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Effects of an educational intervention on frailty status, physical function, physical activity, sleep patterns, and nutritional status of older adults with frailty or pre-frailty: the FRAGSALUD study.
Casals, C, Ávila-Cabeza-de-Vaca, L, González-Mariscal, A, Marín-Galindo, A, Costilla, M, Ponce-Gonzalez, JG, Vázquez-Sánchez, MÁ, Corral-Pérez, J
Frontiers in public health. 2023;11:1267666
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Frailty and pre-frailty are associated with an increased risk of premature mortality. Factors involved in the development of frailty include physical activity, sleep and nutrition. The aim of this 6-month randomised controlled trial was to evaluate the effects of an educational programme on frailty, physical function, physical activity, sleep and nutritional status. 166 community-dwelling individuals aged 65 years or over with frailty or pre-frailty were randomised to either receive a health education programme consisting of 4 group sessions in the first month which included guidelines for physical activity, nutrition and cognitive training as well as the promotion of psychological and social wellbeing and 6 follow-up calls over 6 months or their usual healthcare (control). Compared to the control group, the intervention group had significant reductions in frailty score, exhaustion and fatigue score, increase in gait speed and improvements in various physical function tests. The intervention group also showed significant improvements in mini nutritional assessment compared to the control group although this was not associated with significant changes in anthropometric parameters. There was a significant increase in awakenings in the control group whilst this parameter did not change in the intervention group, whilst there were no changes in other sleep parameters. The authors concluded that the simplicity, affordability and effectiveness of the health education programme may contribute to healthy ageing.
Expert Review
Conflicts of interest:
None
Take Home Message:
To improve frailty and physical functioning, a comprehensive programme may be effective, which includes:
- Nutrition
- Physical exercise
- Cognitive training
- Promotion of social and psychological wellbeing.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
- Frailty and pre-frailty increase the risk of premature mortality but are reversible
- The aim of this study was to evaluate the effects of a health education programme on frailty status in frail or pre-frail older persons.
Methods
- Randomised controlled trial
- Participants: 166 community-dwelling individuals aged 65 years or over with frailty or pre-frailty living in Spain were enrolled, 163 completed the study (80 in intervention and 83 in control group)
- Four weekly group sessions which included guidelines for physical activity, nutrition and cognitive training as well as the promotion of psychological and social wellbeing and 6 follow-up calls over 6 months versus usual healthcare (control).
Results
- Baseline demographics: The educational group consisted of more women (p=0.001), had a younger average age (p=0.019), lower height (p=0.001) and a higher average education level (p=0.013) compared to the control group.
Effects on intervention group:
- Reductions in frailty score (p<0.05 vs baseline and change vs change in control group), with 30% of participants in the intervention group no longer being classified as frail or pre-frail in contrast to none in the control group
- Reductions in fatigue and exhaustion score (p<0.05 vs baseline and change vs change in control group)
- Increase in gait speed and improvements in various physical function tests (all p<0.05 vs baseline and change vs change in control group)
- Improvements in mini nutritional assessment (p<0.001 vs baseline and change vs change in control group)
- Improvement in sleep behaviour demonstrated by an increase in awakenings in the control group (p<0.05 vs baseline and change vs change in intervention group) whilst this parameter did not change in the intervention group.
No effects (vs control) on:
- Anthropometric parameters/unintended weight loss
- Other sleep parameters
- Physical activity expenditure and physical activity score
- Hand grip strength.
Conclusion
This affordable and simple health education programme is effective in reducing frailty in elderly and may contribute to healthy ageing.
Clinical practice applications:
- A comprehensive programme, encompassing not only nutrition, but also exercise, cognitive training and a focus on social and psychological wellbeing may be most effective in improving frailty and physical functioning
- Nutrition intervention, alongside other lifestyle interventions, may have benefits for nutritional status in older adults, even if this is not reflected in a change in anthropometric parameters, such as weight.
Considerations for future research:
- Studies with longer-term follow-up would help evaluate whether/for how long the benefits are sustained.
Abstract
INTRODUCTION The prevalence of frailty is increasing worldwide, emphasizing the importance of prioritizing healthy ageing. To address this, cost-effective and minimally supervised interventions are being sought. This study aimed to assess the impact of an educational program on frailty status, physical function, physical activity, sleep patterns, and nutritional status in community-dwelling older adults with at least 1 Fried's frailty criteria. METHODS A 6-month multicentre randomized controlled trial was conducted from March 2022 to February 2023 in 14 health centres located in Cadiz and Malaga, Spain. The educational intervention consisted of 4 group sessions and 6 follow-up phone calls spread over 6 months. The program focused on educating participants about frailty and its impact on health, providing guidelines for physical activity, healthy dietary habits, cognitive training, psychological well-being and social activities. A total of 163 participants, divided into control (n = 80) and educational groups (n = 83) were assessed before and after the intervention. RESULTS The results showed a significant group-time interaction in the physical function evaluated with a large effect on Short Physical Performance Battery score (η2p = 0.179, -0.1 [-1.2-1.0] points for control group vs. 1.0 [0.0-3.0] points for educational group, p < 0.001), and an effect on the 4-meter gait test ((η2p = 0.122, 0.5 [0.1-0.0] s for control group vs. -0.4 [-0.5- -0.3] s for educational group, p < 0.001), and the 5-repetition sit-to-stand test (η2p = 0.136, 1.0 [0.0-1.2] s for control group vs. -4.3 [-7.0- -2.3] for educational group, p < 0.001). Additionally, the use of accelerometers to assess physical activity, inactivity, and sleep patterns revealed a significant small effect in the number of awakenings at night ((η2p = 0.040, 1.1 [-0.5-3.4] awakenings for control group vs. 0.0 [-2.2-0.0] awakenings for educational group, p = 0.009). The findings also highlighted a significant medium effect regarding malnutrition risk, which was assessed using the Mini-Nutritional Assessment score (η2p = 0.088, -0.7 [-2.3-1.5] points for control group vs. 1.5 [-0.5-3.0] points for educational group, p < 0.001). DISCUSSION Thus, the 6-month educational program effectively improved physical function, sleep patterns, and nutritional status compared to usual healthcare attendance in community-dwelling older adults with frailty or pre-frailty. These findings underscore the potential of minimally supervised interventions in promoting a healthy lifestyle in this vulnerable population.
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Adherence to Mediterranean Diet and NAFLD in Patients with Metabolic Syndrome: The FLIPAN Study.
Montemayor, S, Mascaró, CM, Ugarriza, L, Casares, M, Llompart, I, Abete, I, Zulet, MÁ, Martínez, JA, Tur, JA, Bouzas, C
Nutrients. 2022;14(15)
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Non-alcoholic fatty liver disease (NAFLD) is characterised by fat deposition that is not linked to excessive alcohol intake. This condition is often linked to other health issues such as obesity, metabolic syndrome, type 2 diabetes and cardiovascular disease, and they share common diagnostic biomarkers. An unhealthy diet and lifestyle are also linked to the progression of NAFLD. Mediterranean diet is a predominantly plant-based diet that may have an association with lower risk and reduced severity of NAFLD. This multicentre, prospective, randomised controlled trial included one hundred and thirty-six NAFLD patients to analyse the effect of Mediterranean diet adherence on NAFLD in patients with metabolic syndrome. The NAFLD patients followed a personalised Mediterranean diet and physical activity interventions for six months. Individuals with greater adherence to the Mediterranean diet and physical activity interventions showed improvements in body mass index, body weight, waist circumference, blood pressure and intrahepatic fat content after six months of intervention. Healthcare professionals can use the results of this study to understand the benefits of adherence to the Mediterranean diet and physical activity interventions in reducing NAFLD severity and metabolic irregularities. However, due to the small sample size of this study, further robust studies are required to evaluate the benefits of different dietary strategies, the therapeutic value of different food items and the intervention duration required to achieve improvements in NAFLD and metabolic syndrome.
Abstract
Unhealthy diet is an important factor in the progression of non-alcoholic fatty liver disease (NAFLD). Previous studies showed the benefits of a Mediterranean diet (MedDiet) on Metabolic syndrome (MetS), type 2 diabetes mellitus (T2DM), and cardiovascular diseases, which usually have a pathophysiological relationship with NAFLD. To assess the effect of adherence to a MedDiet on NAFLD in MetS patients after lifestyle intervention, this multicentre (Mallorca and Navarra, Spain) prospective randomized trial, with personalized nutritional intervention based on a customized MedDiet, coupled with physical activity promotion was performed to prevent, and reverse NAFLD among patients with MetS. The current analysis included 138 patients aged 40 to 60 years old, Body Mass Index (BMI) 27-40 kg/m2, diagnosed with NAFLD using MRI, and MetS according to the International Diabetes Federation (IDF). A validated food frequency questionnaire was used to assess dietary intake. Adherence to Mediterranean diet by means of a 17-item validated questionnaire, anthropometrics, physical activity, blood pressure, blood biochemical parameters, and intrahepatic fat contents (IFC) were measured. The independent variable used was changes in MedDiet adherence, categorized in tertiles after 6 months follow-up. Subjects with high adherence to the MedDiet showed higher decreases in BMI, body weight, WC, SBP, DBP, and IFC. An association between improvement in adherence to the MedDiet and amelioration of IFC after 6-month follow-up was observed. High adherence to the MedDiet is associated with better status of MetS features, and better values of IFC.
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The PREVIEW intervention study: Results from a 3-year randomized 2 x 2 factorial multinational trial investigating the role of protein, glycaemic index and physical activity for prevention of type 2 diabetes.
Raben, A, Vestentoft, PS, Brand-Miller, J, Jalo, E, Drummen, M, Simpson, L, Martinez, JA, Handjieva-Darlenska, T, Stratton, G, Huttunen-Lenz, M, et al
Diabetes, obesity & metabolism. 2021;23(2):324-337
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The main risk for the development of type 2 diabetes is being overweight or obese. Strategies to decrease weight are important to prevent its development or reverse disease. This long-term, randomised control trial of 2326 adults with prediabetes, aimed to compare the effectiveness of different maintenance diets, after initial weight loss; one which was high protein and low glycaemic index, and the other which was moderate protein and moderate glycaemic index. These diets were then combined with either moderate intensity or high intensity exercise. The results showed that after 3 years, the incidence of type 2 diabetes was low and did not differ between the diet and exercise groups. However, more individuals achieved normal blood sugar levels when on a moderate protein diet combined with moderate exercise and when on a high protein diet combined with moderate exercise. The high protein diet with high intensity exercise was the least effective at maintaining normal blood sugar levels. The amount of weight lost was the same no matter what combination of diet and exercise. It was concluded that the incidence of type 2 diabetes was lower than expected with the diet and exercise regimes and did not differ between the diets. This study could be used by healthcare professionals to introduce a long-term protocol combining weight loss, healthy eating, and physical activity to pre diabetic individuals who want to reduce their chance of developing type 2 diabetes.
Abstract
AIM: To compare the impact of two long-term weight-maintenance diets, a high protein (HP) and low glycaemic index (GI) diet versus a moderate protein (MP) and moderate GI diet, combined with either high intensity (HI) or moderate intensity physical activity (PA), on the incidence of type 2 diabetes (T2D) after rapid weight loss. MATERIALS AND METHODS A 3-year multicentre randomized trial in eight countries using a 2 x 2 diet-by-PA factorial design was conducted. Eight-week weight reduction was followed by a 3-year randomized weight-maintenance phase. In total, 2326 adults (age 25-70 years, body mass index ≥ 25 kg/m2 ) with prediabetes were enrolled. The primary endpoint was 3-year incidence of T2D analysed by diet treatment. Secondary outcomes included glucose, insulin, HbA1c and body weight. RESULTS The total number of T2D cases was 62 and the cumulative incidence rate was 3.1%, with no significant differences between the two diets, PA or their combination. T2D incidence was similar across intervention centres, irrespective of attrition. Significantly fewer participants achieved normoglycaemia in the HP compared with the MP group (P < .0001). At 3 years, normoglycaemia was lowest in HP-HI (11.9%) compared with the other three groups (20.0%-21.0%, P < .05). There were no group differences in body weight change (-11% after 8-week weight reduction; -5% after 3-year weight maintenance) or in other secondary outcomes. CONCLUSIONS Three-year incidence of T2D was much lower than predicted and did not differ between diets, PA or their combination. Maintaining the target intakes of protein and GI over 3 years was difficult, but the overall protocol combining weight loss, healthy eating and PA was successful in markedly reducing the risk of T2D. This is an important clinically relevant outcome.
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Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study).
Represas-Carrera, F, Couso-Viana, S, Méndez-López, F, Masluk, B, Magallón-Botaya, R, Recio-Rodríguez, JI, Pombo, H, Leiva-Rus, A, Gil-Girbau, M, Motrico, E, et al
International journal of environmental research and public health. 2021;18(11)
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Life habits such as smoking, physical activity, and diet affect glycaemic control. The objective of this multicentre randomised cluster trial (EIRA study) was to evaluate the effectiveness of multicomponent educational interventions on glycaemic control in Type 2 diabetic patients. Interventions in multicomponent individual, group and community settings included smoking cessation, the Mediterranean diet and physical activity, as well as an assessment of the quality of life. Participants had unhealthy lifestyles prior to the intervention. The study was conducted in 26 primary healthcare centres in seven health departments in Spain over a period of 12 months. A brief intervention aimed to change the habits of the participants, including increasing physical activity, quitting smoking and adhering to the Mediterranean diet. After 12 months of intervention, there were no statistically significant improvements in glycaemic control, physical activity, sedentary lifestyle, smoking, or quality of life. However, adherence to the Mediterranean diet was statistically significant. Further research is needed to determine the effectiveness of multicomponent interventions in improving glycaemic control. The clinical applicability of multicomponent interventions to tackle type 2 diabetes, obesity, and unhealthy lifestyles should be considered by healthcare providers.
Abstract
Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45-75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions' effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45-75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = -0.09 (95% CI: -0.29-0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: -0.32-0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01-0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64-1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55-1.73), no smoking OR = 0.61 (95% CI: 0.54-1.06), EVA adjusted mean difference = -1.26 (95% CI: -4.98-2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control.
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Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity Advice on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial.
Mueller, S, Winzer, EB, Duvinage, A, Gevaert, AB, Edelmann, F, Haller, B, Pieske-Kraigher, E, Beckers, P, Bobenko, A, Hommel, J, et al
JAMA. 2021;325(6):542-551
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Heart failure with preserved ejection fraction (HFpEF) is a condition in which the heart's lower left chamber is less able to pump blood due to stiffness. The prevalence of HFpEF is high among the elderly. Endurance exercise is known to increase peak oxygen consumption (Vo2). This prospective, randomised, controlled, three-armed, multi-centre trial aimed to understand the effects of endurance training in older people with HFpEF at 3 and 12 months. In this study, 180 sedentary patients with HFpEF were randomly assigned to high-intensity interval training, moderate continuous training, or control of home-based tele-guideline physical activity advice. The study found no statistically significant difference in changes in V̇o2 between high-intensity interval and moderate continuous training, and neither group met the clinically significant difference of 2.5 mL/kg/min compared with the guideline control. Diastolic function or natriuretic peptides did not change significantly in any group. Adherence level was lower among elderly patients, and there were serious adverse effects in patients with HFpEE. Healthcare professionals can use the findings of this study to understand the impact and adverse effects of endurance training at different intensities in patients with HFpEE.
Abstract
Importance: Endurance exercise is effective in improving peak oxygen consumption (peak V̇o2) in patients with heart failure with preserved ejection fraction (HFpEF). However, it remains unknown whether differing modes of exercise have different effects. Objective: To determine whether high-intensity interval training, moderate continuous training, and guideline-based advice on physical activity have different effects on change in peak V̇o2 in patients with HFpEF. Design, Setting, and Participants: Randomized clinical trial at 5 sites (Berlin, Leipzig, and Munich, Germany; Antwerp, Belgium; and Trondheim, Norway) from July 2014 to September 2018. From 532 screened patients, 180 sedentary patients with chronic, stable HFpEF were enrolled. Outcomes were analyzed by core laboratories blinded to treatment groups; however, the patients and staff conducting the evaluations were not blinded. Interventions: Patients were randomly assigned (1:1:1; n = 60 per group) to high-intensity interval training (3 × 38 minutes/week), moderate continuous training (5 × 40 minutes/week), or guideline control (1-time advice on physical activity according to guidelines) for 12 months (3 months in clinic followed by 9 months telemedically supervised home-based exercise). Main Outcomes and Measures: Primary end point was change in peak V̇o2 after 3 months, with the minimal clinically important difference set at 2.5 mL/kg/min. Secondary end points included changes in metrics of cardiorespiratory fitness, diastolic function, and natriuretic peptides after 3 and 12 months. Results: Among 180 patients who were randomized (mean age, 70 years; 120 women [67%]), 166 (92%) and 154 (86%) completed evaluation at 3 and 12 months, respectively. Change in peak V̇o2 over 3 months for high-intensity interval training vs guideline control was 1.1 vs -0.6 mL/kg/min (difference, 1.5 [95% CI, 0.4 to 2.7]); for moderate continuous training vs guideline control, 1.6 vs -0.6 mL/kg/min (difference, 2.0 [95% CI, 0.9 to 3.1]); and for high-intensity interval training vs moderate continuous training, 1.1 vs 1.6 mL/kg/min (difference, -0.4 [95% CI, -1.4 to 0.6]). No comparisons were statistically significant after 12 months. There were no significant changes in diastolic function or natriuretic peptides. Acute coronary syndrome was recorded in 4 high-intensity interval training patients (7%), 3 moderate continuous training patients (5%), and 5 guideline control patients (8%). Conclusions and Relevance: Among patients with HFpEF, there was no statistically significant difference in change in peak V̇o2 at 3 months between those assigned to high-intensity interval vs moderate continuous training, and neither group met the prespecified minimal clinically important difference compared with the guideline control. These findings do not support either high-intensity interval training or moderate continuous training compared with guideline-based physical activity for patients with HFpEF. Trial Registration: ClinicalTrials.gov Identifier: NCT02078947.
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Usefulness of a Lifestyle Intervention in Patients With Cardiovascular Disease.
Broers, ER, Gavidia, G, Wetzels, M, Ribas, V, Ayoola, I, Piera-Jimenez, J, Widdershoven, JWMG, Habibović, M
The American journal of cardiology. 2020;125(3):370-375
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Modifiable (behavioural) risk factors such as sedentary lifestyle and low sleep efficiency, are associated with increased mortality risk and disease progression in individuals with cardiovascular disease. The main aim of this study was to evaluate changes in objectively measured lifestyle and health data derived from wearable devices. This study was part of an international, multicenter randomized controlled trial, the Do Cardiac Health Advanced New Generation Ecosystem 2 study. Only the participants (n=70) randomised to the intervention group were analysed. The participants received the devices to monitor their lifestyle and health parameters. Results indicate significant changes over time in the number of steps and activity level. No significant improvement over time was observed in other outcome measures (i.e., blood pressure, weight, and sleep efficiency). Secondary analysis showed demographic (gender, nationality, marital status), clinical (co-morbidities, heart failure), and psychological (anxiety, depression) profiles that were associated with lifestyle measures. Authors conclude that a personalised approach might be the way forward in order to improve health outcomes in the future.
Abstract
The importance of modifying lifestyle factors in order to improve prognosis in cardiac patients is well-known. Current study aims to evaluate the effects of a lifestyle intervention on changes in lifestyle- and health data derived from wearable devices. Cardiac patients from Spain (n = 34) and The Netherlands (n = 36) were included in the current analysis. Data were collected for 210 days, using the Fitbit activity tracker, Beddit sleep tracker, Moves app (GPS tracker), and the Careportal home monitoring system. Locally Weighted Error Sum of Squares regression assessed trajectories of outcome variables. Linear Mixed Effects regression analysis was used to find relevant predictors of improvement deterioration of outcome measures. Analysis showed that Number of Steps and Activity Level significantly changed over time (F = 58.21, p < 0.001; F = 6.33, p = 0.01). No significant changes were observed on blood pressure, weight, and sleep efficiency. Secondary analysis revealed that being male was associated with higher activity levels (F = 12.53, p < 0.001) and higher number of steps (F = 8.44, p < 0.01). Secondary analysis revealed demographic (gender, nationality, marital status), clinical (co-morbidities, heart failure), and psychological (anxiety, depression) profiles that were associated with lifestyle measures. In conclusion results showed that physical activity increased over time and that certain subgroups of patients were more likely to have a better lifestyle behaviors based on their demographic, clinical, and psychological profile. This advocates a personalized approach in future studies in order to change lifestyle in cardiac patients.
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Interaction Between Type 2 Diabetes Prevention Strategies and Genetic Determinants of Coronary Artery Disease on Cardiometabolic Risk Factors.
Merino, J, Jablonski, KA, Mercader, JM, Kahn, SE, Chen, L, Harden, M, Delahanty, LM, Araneta, MRG, Walford, GA, Jacobs, SBR, et al
Diabetes. 2020;69(1):112-120
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Individual risk of Coronary Artery Disease (CAD) and type 2 diabetes reflects the interplay between lifestyle behaviours acting on a backdrop of genetic predisposition. The aim of this study was to examine whether type 2 diabetes prevention strategies, either an intensive lifestyle intervention (ILS) or metformin treatment (MET), modify the association between CAD genetic risk and cardiometabolic risk factors (CRFs) in participants at high risk of type 2 diabetes. The study is a randomised controlled trial were participants were randomly allocated to one of the three groups; ILS (n = 1,079), MET (850 mg twice daily [n = 1,073]), or placebo (n = 1,082). Results indicate that there weren’t major significant differences in baseline characteristics, except for lower high-density lipoprotein and higher triglyceride in the placebo individuals compared with individuals assigned to MET or ILS. In fact, either an ILS or MET has a beneficial effect on 1-year change in different CRFs. Authors conclude that type 2 diabetes–preventive strategies for individuals at high risk of type 2 diabetes provide beneficial effects on CRFs regardless of CAD genetic risk profile.
Abstract
Coronary artery disease (CAD) is more frequent among individuals with dysglycemia. Preventive interventions for diabetes can improve cardiometabolic risk factors (CRFs), but it is unclear whether the benefits on CRFs are similar for individuals at different genetic risk for CAD. We built a 201-variant polygenic risk score (PRS) for CAD and tested for interaction with diabetes prevention strategies on 1-year changes in CRFs in 2,658 Diabetes Prevention Program (DPP) participants. We also examined whether separate lifestyle behaviors interact with PRS and affect changes in CRFs in each intervention group. Participants in both the lifestyle and metformin interventions had greater improvement in the majority of recognized CRFs compared with placebo (P < 0.001) irrespective of CAD genetic risk (P interaction > 0.05). We detected nominal significant interactions between PRS and dietary quality and physical activity on 1-year change in BMI, fasting glucose, triglycerides, and HDL cholesterol in individuals randomized to metformin or placebo, but none of them achieved the multiple-testing correction for significance. This study confirms that diabetes preventive interventions improve CRFs regardless of CAD genetic risk and delivers hypothesis-generating data on the varying benefit of increasing physical activity and improving diet on intermediate cardiovascular risk factors depending on individual CAD genetic risk profile.
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A randomized, double blind, placebo controlled, multicenter clinical trial to assess the efficacy and safety of Emblica officinalis extract in patients with dyslipidemia.
Upadya, H, Prabhu, S, Prasad, A, Subramanian, D, Gupta, S, Goel, A
BMC complementary and alternative medicine. 2019;19(1):27
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Emblica officinalis (Amla or Indian gooseberry) is a fruit that has been traditionally used in Ayurvedic medicine. It has been shown to be effective in the management of dyslipidemia (abnormal fat metabolism), a risk factor for heart disease, in animal models and in pilot clinical studies without major side effects. This multicenter, randomised, placebo controlled, double blind clinical trial was designed to evaluate the efficacy and safety of a proprietary full spectrum amla extract (containing pulp and seeds) in patients with dyslipidemia. 98 patients were enrolled and all completed the 12 week study. None of them were taking any medication for their dyslipidaemia. All the patients enrolled in the study were also asked to initiate lifestyle changes (healthy diet with exercise at least 4 days a week). Apart from conventional lipid parameters, the investigators also measured a number of other parameters relevant to heart disease, including the atherogenic index of plasma (AIP, a marker of heart disease risk). Compared to the placebo group the amla group had significantly greater reductions in triglycerides, LDL-cholesterol, VLDL-cholesterol and the atherogenic index of plasma (AIP, a better predictor of heart disease risk). There were no significant changes in HDL-cholesterol, CoQ10 (lowering of CoQ10 is a concern with many cholesterol lowering drugs), homocysteine, thyroid stimulating hormone (TSH) or fasting blood glucose. Four non-serious adverse events were observed: mild headache, mild fever, two times gastritis (all resolved with standard treatment), three were in the placebo group, one in the amla group. There were no changes in routine blood tests and vital signs (blood pressure, heart rate, temperature, respiratory rate). The authors conclude that the amla extract has significant potential to improve dyslipidaemia without side effects commonly seen with cholesterol lowering drugs.
Abstract
BACKGROUND Dyslipidemia is one of the most frequently implicated risk factors for development of atherosclerosis. This study evaluated the efficacy of amla (Emblica officinalis) extract (composed of polyphenols, triterpenoids, oils etc. as found in the fresh wild amla fruit) in patients with dyslipidemia. METHODS A total of 98 dyslipidemic patients were enrolled and divided into amla and placebo groups. Amla extract (500 mg) or a matching placebo capsule was administered twice daily for 12 weeks to the respective group of patients. The patients were followed up for 12 weeks and efficacy of study medication was assessed by analyzing lipid profile. Other parameters evaluated were apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), Coenzyme Q10 (CoQ10), high-sensitive C-reactive protein (hsCRP), fasting blood sugar (FBS), homocysteine and thyroid stimulating hormone (TSH). RESULTS In 12 weeks, the major lipids such as total cholesterol (TC) (p = 0.0003), triglyceride (TG) (p = 0.0003), low density lipoprotein cholesterol (LDL-C) (p = 0.0064) and very low density lipoprotein cholesterol (VLDL-C) (p = 0.0001) were significantly lower in amla group as compared to placebo group. Additionally, a 39% reduction in atherogenic index of the plasma (AIP) (p = 0.0177) was also noted in amla group. The ratio of Apo B to Apo A1 was reduced more (p = 0.0866) in the amla group as compared to the placebo. There was no significant change in CoQ10 level of amla (p = 0.2942) or placebo groups (p = 0.6744). Although there was a general trend of FBS reduction, the numbers of participants who may be classified as pre-diabetes and diabetes groups (FBS > 100 mg/dl) in the amla group were only 8. These results show that the amla extract used in the study is potentially a hypoglycaemic as well. However, this needs reconfirmation in a larger study. CONCLUSIONS The Amla extract has shown significant potential in reducing TC and TG levels as well as lipid ratios, AIP and apoB/apo A-I in dyslipidemic persons and thus has scope to treat general as well as diabetic dyslipidemia. A single agent to reduce cholesterol as well as TG is rare. Cholesterol reduction is achieved without concomitant reduction of Co Q10, in contrast to what is observed with statins. TRIAL REGISTRATION Registered with Clinical Trials Registry- India at www.ctri.nic.in (Registration number: CTRI/2015/04/005682 ) on 8 April 2015 (retrospectively registered).
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One- and Two-Year Effects of the Healthy Primary School of the Future on Children's Dietary and Physical Activity Behaviours: A Quasi-Experimental Study.
Bartelink, NHM, van Assema, P, Kremers, SPJ, Savelberg, HHCM, Oosterhoff, M, Willeboordse, M, van Schayck, OCP, Winkens, B, Jansen, MWJ
Nutrients. 2019;11(3)
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Diet and Physical Activity (PA) habits are formed at a young age, and unhealthy habits can lead to childhood obesity and lifelong health problems. Schools are globally recognised as having access to children across all socio-economic backgrounds and to play an important role in influencing healthy habits. This Dutch experimental longitudinal study looks at the impact Primary schools can have on the health of their students by implementing a dedicated Nutrition and PA Program called ‘Healthy Primary Schools for the Future (HPSF), modelled on an American initiative, piloted in 4 schools and 2 control schools. The study tests whether a fully implemented program (focused on Nutrition and PA - including free lunches & daily PA sessions) or a partial program (focused only on PA sessions) influences healthy change in children’s behaviours versus control schools (no program). The data from 1676 children aged 4-12 yrs was used and the study took place over 3 yrs (2015-2017) with a commitment to continue till 2019 where follow-up data could be obtained. The data was collected once a year using parental and child questionnaires. Additional movement data was obtained from accelerometers the children wore for 7 days during each annual measurement week. The results at year 3 show that a combined nutrition and PA program had greatest benefits on improving diet (variety of foods eaten), and reducing unhealthy snacking, and increasing PA. Neither the partial program or control schools displayed positive changes. The researchers reflect that the full program allowed greater involvement from all parties involved (schools, parents, children’s, educational and health partners) which led to changes becoming an integral part of the school routine. Focusing on nutrition and PA together seemed to encourage complementary behavioural changes compared to focusing only on PA.
Abstract
Schools can help to improve children's health. The 'Healthy Primary School of the Future' (HPSF) aims to sustainably integrate health and well-being into the school system. This study examined the effects of HPSF on children's dietary and physical activity (PA) behaviours after 1 and 2 years' follow-up. The study (n = 1676 children) has a quasi-experimental design with four intervention schools, i.e., two full HPSF (focus: nutrition and PA) and two partial HPSF (focus: PA), and four control schools. Accelerometers and child- and parent-reported questionnaires were used at baseline, after 1 (T1) and 2 (T2) years. Mixed-model analyses showed significant favourable effects for the full HPSF versus control schools for, among others, school water consumption (effect size (ES) = 1.03 (T1), 1.14 (T2)), lunch intake of vegetables (odds ratio (OR) = 3.17 (T1), 4.39 (T2)) and dairy products (OR = 4.43 (T1), 4.52 (T2)), sedentary time (ES = -0.23 (T2)) and light PA (ES = 0.22 (T2)). Almost no significant favourable effects were found for partial HPSF compared to control schools. We conclude that the full HPSF is effective in promoting children's health behaviours at T1 and T2 compared with control schools. Focusing on both nutrition and PA components seems to be more effective in promoting healthy behaviours than focusing exclusively on PA.
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Dietary Inflammatory Index, Dietary Non-Enzymatic Antioxidant Capacity, and Colorectal and Breast Cancer Risk (MCC-Spain Study).
Obón-Santacana, M, Romaguera, D, Gracia-Lavedan, E, Molinuevo, A, Molina-Montes, E, Shivappa, N, Hebert, JR, Tardón, A, Castaño-Vinyals, G, Moratalla, F, et al
Nutrients. 2019;11(6)
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This study aims to correlate the risk factors of inflammation and antioxidant capacity in cases of colon and breast cancer, using data from a large Spanish case-controlled study (1852 colon cancer subjects, 1567 breast cancer subjects and a total 4933 controls). The role of diet in colon cancer is widely accepted, however it is more controversial with breast cancer where genetic mutations and other lifestyle factors are cited as primary risk factors. What unites these cancers is the inter-related presence of both inflammation and oxidative stress. The dietary inflammatory index (DII®) and non-enzymatic antioxidant capacity (NEAC) were used to evaluate inflammation and oxidative stress using 30 nutrient parameters and 6 inflammatory blood markers. The results showed that colon cancer subjects typically ate a more pro-inflammatory diet compared to controls, with a higher odds ratio of men to women, and tended to be older, heavier and less physically active. The breast cancer subjects also had higher inflammatory scores versus controls but demographically were younger, premenopausal, frequently with a first-degree family link to breast cancer, and including a higher percentage of smokers. For both cancers, inflammation significantly and statistically increased risk factors. Adding in oxidative stress results showed a statistically higher risk of developing colon cancer whilst in breast cancer subjects the risk was increased but non-statistically valid. They did report that meat-eaters had a relative 9% increased risk of Breast cancer. Overall the study concluded that dietary components of inflammation and oxidative stress increased risk of colon cancer but were not statistically valid for breast cancer.
Abstract
Inflammation and antioxidant capacity have been associated with colorectal and breast cancer. We computed the dietary inflammatory index (DII®), and the total dietary non-enzymatic antioxidant capacity (NEAC) and associated them with colorectal and breast cancer risk in the population-based multi case-control study in Spain (MCC-Spain). We included 1852 colorectal cancer and 1567 breast cancer cases, and 3447 and 1486 population controls, respectively. DII score and NEAC were derived using data from a semi-quantitative validated food frequency questionnaire. Unconditional logistic regression models were used to estimate odds ratios (OR) and 95% confidence intervals (95%CI) for energy-adjusted DII (E-DII), and a score combining E-DII and NEAC. E-DII was associated with colorectal cancer risk (OR = 1.93, highest quartile versus lowest, 95%CI:1.60-2.32; p-trend: <0.001); this increase was observed for both colon and rectal cancer. Less pronounced increased risks were observed for breast cancer (OR = 1.22, highest quartile versus lowest, 95%CI:0.99-1.52, p-trend: >0.10). The combined score of high E-DII scores and low antioxidant values were associated with colorectal cancer risk (OR = 1.48, highest quartile versus lowest, 95%CI: 1.26-1.74; p-trend: <0.001), but not breast cancer. This study provides evidence that a pro-inflammatory diet is associated with increased colorectal cancer risk while findings for breast cancer were less consistent.