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Effect of Low-Fat vs Low-Carbohydrate Diet on 12-Month Weight Loss in Overweight Adults and the Association With Genotype Pattern or Insulin Secretion: The DIETFITS Randomized Clinical Trial.
Gardner, CD, Trepanowski, JF, Del Gobbo, LC, Hauser, ME, Rigdon, J, Ioannidis, JPA, Desai, M, King, AC
JAMA. 2018;319(7):667-679
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Obesity is a major public health challenge and different dietary strategies are employed to lose weight. This randomised clinical trial of 609 obese adults between the age of 18 and 50 aimed to determine the effects of a healthy low-fat diet in comparison to a healthy low-carbohydrate diet on weight change over a 12 month period. The study also assessed whether 3 genetic markers and blood sugar management affected weight loss in the 2 groups. Participants in the study were offered 22 group sessions of health coaching to support adherence to the programme. 481 participants completed the study. The low-carbohydrate group lost on average 6kg and the low-fat group lost on average 5.4kg. The difference between the 2 groups did not achieve significance for weight loss. There was also no significant genetic or blood sugar management effect in relation to dietary pattern and weight loss. The authors of this study conclude that the results of this study do not help in identifying which dietary type is better for whom in relation to 3 genetic markers and blood sugar management.
Abstract
Importance: Dietary modification remains key to successful weight loss. Yet, no one dietary strategy is consistently superior to others for the general population. Previous research suggests genotype or insulin-glucose dynamics may modify the effects of diets. Objective: To determine the effect of a healthy low-fat (HLF) diet vs a healthy low-carbohydrate (HLC) diet on weight change and if genotype pattern or insulin secretion are related to the dietary effects on weight loss. Design, Setting, and Participants: The Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) randomized clinical trial included 609 adults aged 18 to 50 years without diabetes with a body mass index between 28 and 40. The trial enrollment was from January 29, 2013, through April 14, 2015; the date of final follow-up was May 16, 2016. Participants were randomized to the 12-month HLF or HLC diet. The study also tested whether 3 single-nucleotide polymorphism multilocus genotype responsiveness patterns or insulin secretion (INS-30; blood concentration of insulin 30 minutes after a glucose challenge) were associated with weight loss. Interventions: Health educators delivered the behavior modification intervention to HLF (n = 305) and HLC (n = 304) participants via 22 diet-specific small group sessions administered over 12 months. The sessions focused on ways to achieve the lowest fat or carbohydrate intake that could be maintained long-term and emphasized diet quality. Main Outcomes and Measures: Primary outcome was 12-month weight change and determination of whether there were significant interactions among diet type and genotype pattern, diet and insulin secretion, and diet and weight loss. Results: Among 609 participants randomized (mean age, 40 [SD, 7] years; 57% women; mean body mass index, 33 [SD, 3]; 244 [40%] had a low-fat genotype; 180 [30%] had a low-carbohydrate genotype; mean baseline INS-30, 93 μIU/mL), 481 (79%) completed the trial. In the HLF vs HLC diets, respectively, the mean 12-month macronutrient distributions were 48% vs 30% for carbohydrates, 29% vs 45% for fat, and 21% vs 23% for protein. Weight change at 12 months was -5.3 kg for the HLF diet vs -6.0 kg for the HLC diet (mean between-group difference, 0.7 kg [95% CI, -0.2 to 1.6 kg]). There was no significant diet-genotype pattern interaction (P = .20) or diet-insulin secretion (INS-30) interaction (P = .47) with 12-month weight loss. There were 18 adverse events or serious adverse events that were evenly distributed across the 2 diet groups. Conclusions and Relevance: In this 12-month weight loss diet study, there was no significant difference in weight change between a healthy low-fat diet vs a healthy low-carbohydrate diet, and neither genotype pattern nor baseline insulin secretion was associated with the dietary effects on weight loss. In the context of these 2 common weight loss diet approaches, neither of the 2 hypothesized predisposing factors was helpful in identifying which diet was better for whom. Trial Registration: clinicaltrials.gov Identifier: NCT01826591.
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Micronutrient Gaps in Three Commercial Weight-Loss Diet Plans.
G Engel, M, J Kern, H, Brenna, JT, H Mitmesser, S
Nutrients. 2018;10(1)
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Globally, around 39% of adults are overweight and 13% obese, and more than one third of American adults are obese. Being overweight or obese is associated with many chronic conditions, such as heart disease, high blood pressure and type 2 diabetes. Weight loss, even at moderate level, can reduce the risk of these obesity-related chronic conditions. Commercial weight-loss diet plans can vary greatly, not only in energy content but also in macronutrient and micronutrient composition. Most plans restrict calories or certain macronutrients, particularly carbohydrate or fat, and in doing so, often overlook micronutrient, i.e. vitamin and mineral, content. Previous studies have shown that many weight-loss plans do not provide adequate amounts of all micronutrients, and in order to reach the reference daily intakes for various vitamins and minerals, dieters would need to increase their calorie intake significantly and often unrealistically. The authors of this paper analysed seven single-day menus of three select commercial diet plans to determine their micronutrient sufficiency. The diet plans included were Eat to Live-Vegan, Aggressive Weight Loss (ETL-VAWL), Fast Metabolism Diet (FMD), and Eat, Drink and Be Healthy (EDH). ETL-VAWL diet provided less than 90% of recommended amounts for B12, B3, D, E, calcium, selenium and zinc. The FMD diet was low in B1, D, E, calcium, magnesium and potassium, while EDH diet didn’t meet the recommended amounts for vitamin D, calcium and potassium. Even after adjusting all the plans to an intake of 2000 kcal/day, several micronutrients were found to remain inadequate (vitamin B12 in ETL-VAWL, calcium in FMD and EDH and vitamin D in all diets). The authors conclude that, in order to reduce the risk of micronutrient deficiencies, more attention needs to be paid to micronutrient rich foods when designing commercial diet plans. Alternatively, these nutrient gaps should be filled in other ways, e.g. using appropriate dietary supplements.
Abstract
Weight-loss diets restrict intakes of energy and macronutrients but overlook micronutrient profiles. Commercial diet plans may provide insufficient micronutrients. We analyzed nutrient profiles of three plans and compared their micronutrient sufficiency to Dietary Reference Intakes (DRIs) for male U.S. adults. Hypocaloric vegan (Eat to Live-Vegan, Aggressive Weight Loss; ETL-VAWL), high-animal-protein low-carbohydrate (Fast Metabolism Diet; FMD) and weight maintenance (Eat, Drink and Be Healthy; EDH) diets were evaluated. Seven single-day menus were sampled per diet (n = 21 menus, 7 menus/diet) and analyzed for 20 micronutrients with the online nutrient tracker CRON-O-Meter. Without adjustment for energy intake, the ETL-VAWL diet failed to provide 90% of recommended amounts for B12, B₃, D, E, calcium, selenium and zinc. The FMD diet was low (<90% DRI) in B₁, D, E, calcium, magnesium and potassium. The EDH diet met >90% DRIs for all but vitamin D, calcium and potassium. Several micronutrients remained inadequate after adjustment to 2000 kcal/day: vitamin B12 in ETL-VAWL, calcium in FMD and EDH and vitamin D in all diets. Consistent with previous work, micronutrient deficits are prevalent in weight-loss diet plans. Special attention to micronutrient rich foods is required to reduce risk of micronutrient deficiency in design of commercial diets.
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Effects of Providing High-Fat versus High-Carbohydrate Meals on Daily and Postprandial Physical Activity and Glucose Patterns: a Randomised Controlled Trial.
Parr, EB, Devlin, BL, Callahan, MJ, Radford, BE, Blankenship, JM, Dunstan, DW, Hawley, JA
Nutrients. 2018;10(5)
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The timing of habitual meal consumption and composition is known to be an important factor in health status, particularly for blood glucose regulation. The aim of this randomised crossover study was to assess the effects of altering meal timing and diet composition on postprandial glucose and physical activity levels. Eight overweight or obese men with a sedentary lifestyle completed two 12-day measurement periods including a 7-day habitual period followed by a 5-day experimental period, with an 8-day washout period. The two conditions tested were a high-fat, low carbohydrate diet (HFD) and a high-carbohydrate, low-fat diet (HCD) and participants were instructed to consume meals at standardised times throughout both conditions. Body composition, oxygen consumption and blood glucose were measured at baseline and between each experimental condition. This trial found the provision of meals did not alter overall activity patterns or postprandial activity patterns. The authors observed increased sedentary activity across the day, and identify evening time as an important target for sedentary time to be minimised. Based on these results, the authors suggest that future dietary interventions consider habitual meal consumption and composition to best replicate real-world behaviours.
Abstract
We determined the effects of altering meal timing and diet composition on temporal glucose homeostasis and physical activity measures. Eight sedentary, overweight/obese men (mean ± SD, age: 36 ± 4 years; BMI: 29.8 ± 1.8 kg/m²) completed two × 12-day (12-d) measurement periods, including a 7-d habitual period, and then 5 d of each diet (high-fat diet [HFD]: 67:15:18% fat:carbohydrate:protein versus high-carbohydrate diet [HCD]: 67:15:18% carbohydrate:fat:protein) of three meals/d at ±30 min of 0800 h, 1230 h, and 1800 h, in a randomised order with an 8-d washout. Energy intake (EI), the timing of meal consumption, blood glucose regulation (continuous glucose monitor system (CGMS)), and activity patterns (accelerometer and inclinometer) were assessed across each 12-d period. Meal provision did not alter the patterns of reduced physical activity, and increased sedentary behaviour following dinner, compared with following breakfast and lunch. The HCD increased peak (+1.6 mmol/L, p < 0.001), mean (+0.5 mmol/L, p = 0.001), and total area under the curve (+670 mmol/L/min, p = 0.001), as well as 3-h postprandial meal glucose concentrations (all p < 0.001) compared with the HFD. In overweight/obese males, the provision of meals did not alter physical activity patterns, but did affect glycaemic control. Greater emphasis on meal timing and composition is required in diet and/or behaviour intervention studies to ensure relevance to real-world behaviours.
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Randomised trial of coconut oil, olive oil or butter on blood lipids and other cardiovascular risk factors in healthy men and women.
Khaw, KT, Sharp, SJ, Finikarides, L, Afzal, I, Lentjes, M, Luben, R, Forouhi, NG
BMJ open. 2018;8(3):e020167
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Blood lipids is a term used for fatty substances found in the blood such as cholesterol and triglycerides. When these fatty substances are above a normal level it may increase an individual’s risk factors for coronary heart diseases. A diet high in saturated fats is linked to an increased amount of these fats in the blood. Recent renewed interest in the health effects of saturated fats based on their composition (long chain, medium chain, and short chain) brought about this randomised control trial. The aim of the study was to compare the effects of butter, extra virgin coconut oil and olive oil on blood lipids. The study population were men and women aged between 50 and 70 years who did not have any known medical history of heart disease or were on any medication related to heart disease. At the end of the four week trial period, significant changes in the blood lipids were observed within the three intervention groups. The concentration of LDL cholesterol in the butter group when compared with coconut oil and olive oil showed a significant increase, whilst no difference was observed in the LDL cholesterol concentration between the olive oil and coconut oil group. The concentration of HDL cholesterol in the coconut oil group increased significantly in comparison to the butter or olive oil group. However, the authors concluded that as further trials between different fatty acids and health are required, the current recommendation of the American Heart Association - to reduce saturated fat in general - is strongly recommended.
Abstract
INTRODUCTION High dietary saturated fat intake is associated with higher blood concentrations of low-density lipoprotein cholesterol (LDL-C), an established risk factor for coronary heart disease. However, there is increasing interest in whether various dietary oils or fats with different fatty acid profiles such as extra virgin coconut oil may have different metabolic effects but trials have reported inconsistent results. We aimed to compare changes in blood lipid profile, weight, fat distribution and metabolic markers after four weeks consumption of 50 g daily of one of three different dietary fats, extra virgin coconut oil, butter or extra virgin olive oil, in healthy men and women in the general population. DESIGN Randomised clinical trial conducted over June and July 2017. SETTING General community in Cambridgeshire, UK. PARTICIPANTS Volunteer adults were recruited by the British Broadcasting Corporation through their websites. Eligibility criteria were men and women aged 50-75 years, with no known history of cancer, cardiovascular disease or diabetes, not on lipid lowering medication, no contraindications to a high-fat diet and willingness to be randomised to consume one of the three dietary fats for 4 weeks. Of 160 individuals initially expressing an interest and assessed for eligibility, 96 were randomised to one of three interventions; 2 individuals subsequently withdrew and 94 men and women attended a baseline assessment. Their mean age was 60 years, 67% were women and 98% were European Caucasian. Of these, 91 men and women attended a follow-up assessment 4 weeks later. INTERVENTION Participants were randomised to extra virgin coconut oil, extra virgin olive oil or unsalted butter and asked to consume 50 g daily of one of these fats for 4 weeks, which they could incorporate into their usual diet or consume as a supplement. MAIN OUTCOMES AND MEASURES The primary outcome was change in serum LDL-C; secondary outcomes were change in total and high-density lipoprotein cholesterol (TC and HDL-C), TC/HDL-C ratio and non-HDL-C; change in weight, body mass index (BMI), waist circumference, per cent body fat, systolic and diastolic blood pressure, fasting plasma glucose and C reactive protein. RESULTS LDL-C concentrations were significantly increased on butter compared with coconut oil (+0.42, 95% CI 0.19 to 0.65 mmol/L, P<0.0001) and with olive oil (+0.38, 95% CI 0.16 to 0.60 mmol/L, P<0.0001), with no differences in change of LDL-C in coconut oil compared with olive oil (-0.04, 95% CI -0.27 to 0.19 mmol/L, P=0.74). Coconut oil significantly increased HDL-C compared with butter (+0.18, 95% CI 0.06 to 0.30 mmol/L) or olive oil (+0.16, 95% CI 0.03 to 0.28 mmol/L). Butter significantly increased TC/HDL-C ratio and non-HDL-C compared with coconut oil but coconut oil did not significantly differ from olive oil for TC/HDL-C and non-HDL-C. There were no significant differences in changes in weight, BMI, central adiposity, fasting blood glucose, systolic or diastolic blood pressure among any of the three intervention groups. CONCLUSIONS AND RELEVANCE Two different dietary fats (butter and coconut oil) which are predominantly saturated fats, appear to have different effects on blood lipids compared with olive oil, a predominantly monounsaturated fat with coconut oil more comparable to olive oil with respect to LDL-C. The effects of different dietary fats on lipid profiles, metabolic markers and health outcomes may vary not just according to the general classification of their main component fatty acids as saturated or unsaturated but possibly according to different profiles in individual fatty acids, processing methods as well as the foods in which they are consumed or dietary patterns. These findings do not alter current dietary recommendations to reduce saturated fat intake in general but highlight the need for further elucidation of the more nuanced relationships between different dietary fats and health. TRIAL REGISTRATION NUMBER NCT03105947; Results.
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Does adapted physical activity‑based rehabilitation improve mental and physical functioning? A randomized trial.
Røe, C, Preede, L, Dalen, H, Bautz-Holter, E, Nyquist, A, Sandvik, L, Saebu, M
European journal of physical and rehabilitation medicine. 2018;54(3):419-427
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Physical and mental functioning is reduced in people with chronic disability. Adapted physical activity (APA) programmes have been developed to facilitate physical activity in this population, but the mental effects have not yet been addressed. The aim of this study was to determine both the physical and mental effects of an APA programme in 202 patients with chronic disability. Participants were randomised to either join an in-patient APA rehabilitation programme or a waitlist control group. Those in the APA programme received 2-5 hours of guided activity every day for 6 days a week, as well as 1-3 hours of a social or cultural activities. Various questionnaires were completed at baseline and at the end of the intervention. This study found participants receiving the APA rehabilitation programme showed improvements in physical functioning, motivation, self-efficacy (a feeling that 'I can do' an action), pain and fatigue compared with the waitlist group. Based on these results, the authors conclude physical activity should be considered during the development of rehabilitation strategies for people with chronic disabilities.
Abstract
BACKGROUND Persons with chronic disabilities face a wide variety of problems with functioning that affect their level of physical activity and participation. We have limited knowledge about the effect of adapted physical activity (APA)-based rehabilitation on perceived mental and physical functioning. AIM: The main aim of this study was to evaluate the effect of APA‑based rehabilitation compared to waiting‑list on perceived mental and physical functioning. Secondly, we wanted to assess whether improvement in self‑efficacy, motivation, pain and fatigue during rehabilitation was related to the effect of the intervention. DESIGN Randomized controlled trial. SETTING In‑patient rehabilitation Center. POPULATION All subjects above 17 years who were referred by their physician to BHC between July 1, 2010 and August 1, 2012 without major cognitive or language problems were eligible for the study (N.=321). METHODS Persons above 17 years (men and women) with chronic disabilities who applied for a rehabilitation stay, were randomized to an adapted physical activity‑based rehabilitation intervention (N.=304) or waiting‑list with delayed rehabilitation. A total of 246 consented and were allocated to four week intervention or a waiting‑list control group. The main outcome was physical and mental functioning evaluated four weeks after rehabilitation using the Medical Outcomes Study 12-Item Short‑Form Health Survey (SF-12). RESULTS Compared to waiting‑list the adapted physical activity‑based intervention improved physical and mental functioning. Improvement in physical functioning during rehabilitation was related to reduced pain, improved motivation and self‑efficacy. CONCLUSIONS The results indicate that an adapted physical activity‑based rehabilitation program improves functioning. Improved efficacy for managing disability may mediate the improvement in mental functioning. CLINICAL REHABILITATION IMPACT Adapted physical activity‑based rehabilitation should be considered during the development of rehabilitation strategies for people with chronic disabilities. Motivational and self‑efficacy aspects must be addressed when organizing and evaluating rehabilitation programs.
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Comparison of the construct validity and reproducibility of four different types of patient-reported outcome measures (PROMs) in patients with rheumatoid arthritis.
Renskers, L, van Uden, RJJC, Huis, AMP, Rongen, SAA, Teerenstra, S, van Riel, PLCM
Clinical rheumatology. 2018;37(12):3191-3199
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Rheumatoid arthritis is an inflammatory autoimmune disease characterised by chronic joint inflammation, which leads to pain, stiffness, function loss, and fatigue. During outpatient visits, patient-reported outcome measures (PROMs) are taking a more central place because they directly apply to the patients’ personal perception and can identify key concerns that need to be addressed. The objective of this study was to measure and compare construct validity of four scale types of PROMs within four different domains. The study is a prospective longitudinal study which recruited adult patients with rheumatoid arthritis. Two-hundred eleven patients were included for the construct validity assessment and one hundred fifty-three patients for the reproducibility assessment. Results showed that within the construct validity assessment, the differences between the four scale types were small and appeared not different. On the other hand, the assessment on reproducibility of the scales was moderate to high. The exception was for the domain of general well-being, as correlations both for construct validity as well as for reproducibility were lower compared to the other domains. Authors conclude that the numerical rating scale is the preferred PROM scale for patients with rheumatoid arthritis.
Abstract
Patient-reported outcome measures (PROMs) are increasingly used in the assessment of patients with rheumatoid arthritis (RA). The aim of this study was to assess the construct validity and reproducibility of four types of PROMs (numerical rating scale (NRS), visual analogue scale (VAS), verbal rating scale (VRS), and Likert scale). In addition, patients' preference for one of these PROMs was measured. Patients with stable RA and no change in pain medication or steroid medication (n = 211) were asked to complete a questionnaire directly following, and 5 days after their outpatient visit. The questionnaire measured the validity of the PROMs in four domains (pain, fatigue, experienced disease activity, and general well-being). To assess construct validity, Pearson correlation coefficients were calculated using the Disease Activity Score-3. To assess reproducibility, intraclass correlation coefficients (ICCs) were calculated. Correlation coefficients between the different PROMs within each domain were compared. There were no differences regarding construct validity between the different PROM scale types. Regarding reproducibility, VAS and NRS scored better in the domains pain and experienced disease activity. Patients chose NRS as preferred measurement method, with the VAS in second place. The four scale types of PROMs appeared to be equally valid to assess pain, fatigue, experienced disease activity, and general well-being. VAS and NRS appeared to be more reliable for measuring pain and experienced disease activity. The patients favoured NRS. In combination with other practical advantages of NRS over VAS, we do advise the NRS as the preferred scale type for PROMs.
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Effect of intermittent vs. daily calorie restriction on changes in weight and patient-reported outcomes in people with multiple sclerosis.
Fitzgerald, KC, Vizthum, D, Henry-Barron, B, Schweitzer, A, Cassard, SD, Kossoff, E, Hartman, AL, Kapogiannis, D, Sullivan, P, Baer, DJ, et al
Multiple sclerosis and related disorders. 2018;23:33-39
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Multiple sclerosis (MS) is a disease of the central nervous system. Dietary modification is emerging as a safe intervention to potentially modify disease course. The main aim of this study was to assess the safety and feasibility of an intermittent fasting diet in people with MS. Secondary outcomes explored the effects of calorie restriction (CR) diets on body weight and anthropometric characteristics as well as on patient-reported outcomes including fatigue, sleep and mood. The study is a pilot randomised controlled feeding study of three different types of diets. Each participant (n=36) was randomized to 1 of 3 diets: a control diet (placebo), a daily CR diet and intermittent CR diet. Results indicate that daily CR diet was associated with marginally greater weight loss than the intermittent CR diet. Both CR diets were associated with trends toward improvements in cardiometabolic outcomes. Furthermore, CR diets were associated with in improvements in emotional well-being. Authors conclude that CR and weight loss represent interventions for clinically relevant symptoms due to MS, such as emotional well-being, without adding meaningful risks or adverse outcomes.
Abstract
An intermittent fasting or calorie restriction diet has favorable effects in the mouse forms of multiple sclerosis (MS) and may provide additional anti-inflammatory and neuroprotective advantages beyond benefits obtained from weight loss alone. We conducted a pilot randomized controlled feeding study in 36 people with MS to assess safety and feasibility of different types of calorie restriction (CR) diets and assess their effects on weight and patient reported outcomes in people with MS. Patients were randomized to receive 1 of 3 diets for 8 weeks: daily CR diet (22% daily reduction in energy needs), intermittent CR diet (75% reduction in energy needs, 2 days/week; 0% reduction, 5 days/week), or a weight-stable diet (0% reduction in energy needs, 7 days/week). Of the 36 patients enrolled, 31 (86%) completed the trial; no significant adverse events occurred. Participants randomized to CR diets lost a median 3.4 kg (interquartile range [IQR]: -2.4, -4.0). Changes in weight did not differ significantly by type of CR diet, although participants randomized to daily CR tended to have greater weight loss (daily CR: -3.6 kg [IQR: -3.0, -4.1] vs. intermittent CR: -3.0 kg [IQR: -1.95, -4.1]; P = 0.15). Adherence to study diets differed significantly between intermittent CR vs. daily CR, with lesser adherence observed for intermittent CR (P = 0.002). Randomization to either CR diet was associated with significant improvements in emotional well-being/depression scores relative to control, with an average 8-week increase of 1.69 points (95% CI: 0.72, 2.66). CR diets are a safe/feasible way to achieve weight loss in people with MS and may be associated with improved emotional health.
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Anti-Inflammatory Effects of a Vegan Diet Versus the American Heart Association-Recommended Diet in Coronary Artery Disease Trial.
Shah, B, Newman, JD, Woolf, K, Ganguzza, L, Guo, Y, Allen, N, Zhong, J, Fisher, EA, Slater, J
Journal of the American Heart Association. 2018;7(23):e011367
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Inflammation plays a central role in the progression of atherosclerosis and is associated with adverse cardiovascular events. The aim of this study was to determine the effects of a vegan versus American Heart Association (AHA)-recommended diet on high-sensitivity C-reactive protein (hsCRP) [a type of protein found in blood plasma], as well as other markers of inflammation, glucometabolic markers, and lipid profiles in patients with established coronary artery disease (CAD) on guideline-directed medical therapy. This study is a prospective, randomized, open-label, blinded end point study design. The active study duration was 8 weeks, with an interim visit at 4 weeks and a final visit at 8 weeks. Results show: - a significantly greater reduction in hsCRP with a vegan versus AHA-recommended diet in patients with established CAD on guideline-directed medical therapy. - that the degree of weight loss, as measured by both body mass index and waist circumference, did not significantly differ between the 2 diet groups. - that markers of glycaemic control and lipid profiles, overall, also did not significantly differ in the vegan diet group when compared with the AHA-recommended diet group. Authors conclude that in patients with CAD and an elevated hsCRP, despite guideline-directed medical therapy, a vegan diet may be considered to further lower the parameters of inflammation.
Abstract
Background Dietary interventions may play a role in secondary cardiovascular prevention. hsCRP (High-sensitivity C-reactive protein) is a marker of risk for major adverse cardiovascular outcomes in coronary artery disease. Methods and Results The open-label, blinded end-point, EVADE CAD (Effects of a Vegan Versus the American Heart Association-Recommended Diet in Coronary Artery Disease) trial randomized participants (n=100) with coronary artery disease to 8 weeks of a vegan or American Heart Association-recommended diet with provision of groceries, tools to measure dietary intake, and dietary counseling. The primary end point was high-sensitivity C-reactive protein. A linear regression model compared end points after 8 weeks of a vegan versus American Heart Association diet and adjusted for baseline concentration of the end point. Significance levels for the primary and secondary end points were set at 0.05 and 0.0015, respectively. A vegan diet resulted in a significant 32% lower high-sensitivity C-reactive protein (β, 0.68, 95% confidence interval [0.49-0.94]; P=0.02) when compared with the American Heart Association diet. Results were consistent after adjustment for age, race, baseline waist circumference, diabetes mellitus, and prior myocardial infarction (adjusted β, 0.67 [0.47-0.94], P=0.02). The degree of reduction in body mass index and waist circumference did not significantly differ between the 2 diet groups (adjusted β, 0.99 [0.97-1.00], P=0.10; and adjusted β, 1.00 [0.98-1.01], P=0.66, respectively). There were also no significant differences in markers of glycemic control between the 2 diet groups. There was a nonsignificant 13% reduction in low-density lipoprotein cholesterol with the vegan diet when compared with the American Heart Association diet (adjusted β, 0.87 [0.78-0.97], P=0.01). There were no significant differences in other lipid parameters. Conclusions In patients with coronary artery disease on guideline-directed medical therapy, a vegan diet may be considered to lower high-sensitivity C-reactive protein as a risk marker of adverse outcomes. Clinical Trial Registration URL http://www.clinicaltrials.gov . Unique identifier: NCT 02135939.
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Long-term outcome of patients with steroid-refractory acute severe UC treated with ciclosporin or infliximab.
Laharie, D, Bourreille, A, Branche, J, Allez, M, Bouhnik, Y, Filippi, J, Zerbib, F, Savoye, G, Vuitton, L, Moreau, J, et al
Gut. 2018;67(2):237-243
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Intravenous steroids are the first-line therapy for ulcerative colitis (UC) patients who are hospitalised during a severe UC flare-up. In the 40% of patients who don’t respond to steroids, the drugs ciclosporin and infliximab have been found to be efficient in preventing surgery to remove part or all of the colon, but there is a lack of data on the long-term outcomes of using these medications in UC patients. The aim of this study was to assess long-term outcome of patients included in a randomised trial comparing ciclosporin and infliximab. Between 2007 and 2010, 115 patients with UC that did not respond to steroids were randomised to receive ciclosporin or infliximab in association with azathioprine. Patients were followed to January 2015 or death. After a median follow-up of 5.4 years, colectomy-free survival rates at 1 and 5 years were, respectively, 70.9% and 61.5% in patients who received ciclosporin and 69.1% and 65.1% in those who received infliximab. Long-term colectomy-free survival was independent from initial treatment. However, a higher proportion of patients initially treated with ciclosporin needed a new treatment compared with those who received infliximab first. The researchers concluded that these results further confirm a similar efficacy and good safety profiles of both drugs.
Abstract
OBJECTIVE Ciclosporin and infliximab have demonstrated short-term similar efficacy as second-line therapies in patients with acute severe UC (ASUC) refractory to intravenous steroids. The aim of this study was to assess long-term outcome of patients included in a randomised trial comparing ciclosporin and infliximab. DESIGN Between 2007 and 2010, 115 patients with steroid-refractory ASUC were randomised in 29 European centres to receive ciclosporin or infliximab in association with azathioprine. Patients were followed until death or last news up to January 2015. Colectomy-free survival rates at 1 and 5 years and changes in therapy were estimated through Kaplan-Meier method and compared between initial treatment groups through log-rank test. RESULTS After a median follow-up of 5.4 years, colectomy-free survival rates (95% CI) at 1 and 5 years were, respectively, 70.9% (59.2% to 82.6%) and 61.5% (48.7% to 74.2%) in patients who received ciclosporin and 69.1% (56.9% to 81.3%) and 65.1% (52.4% to 77.8%) in those who received infliximab (p=0.97). Cumulative incidence of first infliximab use at 1 and 5 years in patients initially treated with ciclosporin was, respectively, 45.7% (32.6% to 57.9%) and 57.1% (43.0% to 69.0%). Only four patients from the infliximab group were subsequently switched to ciclosporin. Three patients died during the follow-up, none directly related to UC or its treatment. CONCLUSIONS In this cohort of patients with steroid-refractory ASUC initially treated by ciclosporin or infliximab, long-term colectomy-free survival was independent from initial treatment. These long-term results further confirm a similar efficacy and good safety profiles of both drugs and do not favour one drug over the other. TRIAL REGISTRATION NUMBER EudraCT: 2006-005299-42; ClinicalTrials.gouv number: NCT00542152; post-results.
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Hypothesis and data-driven dietary patterns and colorectal Cancer survival: findings from Newfoundland and Labrador colorectal Cancer cohort.
Sharma, I, Roebothan, B, Zhu, Y, Woodrow, J, Parfrey, PS, Mclaughlin, JR, Wang, PP
Nutrition journal. 2018;17(1):55
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Diet and lifestyle play a role in the risk and outcome of chronic diseases including colorectal cancer (CRC). This prospective follow-up study looked at the association between different dietary patterns and the risk of death and cancer recurrence in people with CRC. Over 500 CRC patients diagnosed between 1999 and 2003 were followed-up until 2010. Participants completed a food frequency questionnaire based on their diet a year prior to diagnosis, and this was used to identify several dietary patterns. Diets that were high in processed meats (HR 1.82), meat and dairy products (HR 2.19), and total grains, sugar and soft drinks (HR 1.95) were associated with a higher risk of mortality, cancer recurrence or metastasis. Poor adherence to a Mediterranean-style diet increased the risk of overall mortality (HR 1.62). Prudent vegetable, high sugar pattern, Recommended Food Scores and Dietary Inflammatory Index had no significant association with either mortality or combined mortality, recurrence or metastasis. The authors concluded that the risk of mortality, recurrence and metastasis in patients with colorectal cancer varies with different dietary patterns.
Abstract
BACKGROUND Dietary patterns are commonly used in epidemiological research, yet there have been few studies assessing if and how research results may vary across dietary patterns. This study aimed to estimate the risk of mortality/recurrence/metastasis using different dietary patterns and comparison amongst the patterns. METHODS Dietary patterns were identified by Cluster Analysis (CA), Principal Component Analysis (PCA), Alternate Mediterranean Diet score (altMED), Recommended Food Score (RFS) and Dietary Inflammatory Index (DII) scores using a 169-item food frequency questionnaire. Five hundred thirty-two colorectal cancer patients diagnosed between 1999 and 2003 in Newfoundland were followed-up until 2010. Overall Mortality (OM) and combined Mortality, Recurrence or Metastasis (cMRM) were identified. Comparisons were made with adjusted Cox proportional Hazards Ratios (HRs), correlation coefficients and the distributions of individuals in defined clusters by quartiles of factor and index scores. RESULTS One hundred and seventy cases died from all causes and 29 had a cancer recurrence/metastasis during follow-up. Processed meats as classified by PCA (HR 1.82; 95% confidence interval (CI) 1.07-3.09), clusters characterized by meat and dairy products (HR 2.19; 95% CI 1.03-4.67) and total grains, sugar, soft drinks (HR 1.95; 95% CI 1.13-3.37) were associated with a higher risk of cMRM. Poor adherence to AltMED increased the risk of all-cause OM (HR 1.62; 95% CI 1.04-2.56). Prudent vegetable, high sugar pattern, RFS and DII had no significant association with both OM and cMRM. CONCLUSION Estimation of OM and cMRM varied across dietary patterns which is attributed to the differences in the foundation of each pattern.