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Effect of a Nutritional and Behavioral Intervention on Energy-Reduced Mediterranean Diet Adherence Among Patients With Metabolic Syndrome: Interim Analysis of the PREDIMED-Plus Randomized Clinical Trial.
Sayón-Orea, C, Razquin, C, Bulló, M, Corella, D, Fitó, M, Romaguera, D, Vioque, J, Alonso-Gómez, ÁM, Wärnberg, J, Martínez, JA, et al
JAMA. 2019;322(15):1486-1499
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Excess caloric intake and poor nutritional quality are associated with overweight and obesity. A traditional Mediterranean diet has been shown to reduce all-cause mortality, and in particular to reduce risk of cardiovascular disease, type 2 diabetes mellitus and overweight. The aim of this randomised, prospective, single-blinded study was to evaluate the effectiveness of an intensive lifestyle intervention programme in 6874 overweight or obese men and women with metabolic syndrome in Spain. The intervention group was advised on an energy-reduced Mediterranean diet and exercise and received behavioural support, with initial group sessions and interviews, and monthly follow-up phone calls for one year. The control group received advice on a Mediterranean diet and usual care, with 6 monthly follow-ups. After 12 months, the more intensively counselled patients showed a significantly better adherence to an energy-reduced Mediterranean diet than the control group. They had greater reductions in refined grains, pastries, red and processed meats and greater increases in vegetable, fruit and nut consumption than the control group. The intervention group had also better improvements in cardiovascular risk factors.
Abstract
Importance: High-quality dietary patterns may help prevent chronic disease, but limited data exist from randomized trials about the effects of nutritional and behavioral interventions on dietary changes. Objective: To assess the effect of a nutritional and physical activity education program on dietary quality. Design, Setting, and Participants: Preliminary exploratory interim analysis of an ongoing randomized trial. In 23 research centers in Spain, 6874 men and women aged 55 to 75 years with metabolic syndrome and no cardiovascular disease were enrolled in the trial between September 2013 and December 2016, with final data collection in March 2019. Interventions: Participants were randomized to an intervention group that encouraged an energy-reduced Mediterranean diet, promoted physical activity, and provided behavioral support (n = 3406) or to a control group that encouraged an energy-unrestricted Mediterranean diet (n = 3468). All participants received allotments of extra-virgin olive oil (1 L/mo) and nuts (125 g/mo) for free. Main Outcomes and Measures: The primary outcome was 12-month change in adherence based on the energy-reduced Mediterranean diet (er-MedDiet) score (range, 0-17; higher scores indicate greater adherence; minimal clinically important difference, 1 point). Results: Among 6874 randomized participants (mean [SD] age, 65.0 [4.9] years; 3406 [52%] men), 6583 (96%) completed the 12-month follow-up and were included in the main analysis. The mean (SD) er-MedDiet score was 8.5 (2.6) at baseline and 13.2 (2.7) at 12 months in the intervention group (increase, 4.7 [95% CI, 4.6-4.8]) and 8.6 (2.7) at baseline and 11.1 (2.8) at 12 months in the control group (increase, 2.5 [95% CI, 2.3-2.6]) (between-group difference, 2.2 [95% CI, 2.1-2.4]; P < .001). Conclusions and Relevance: In this preliminary analysis of an ongoing trial, an intervention that encouraged an energy-reduced Mediterranean diet and physical activity, compared with advice to follow an energy-unrestricted Mediterranean diet, resulted in a significantly greater increase in diet adherence after 12 months. Further evaluation of long-term cardiovascular effects is needed. Trial Registration: isrctn.com Identifier: ISRCTN89898870.
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Comparison of the Effects of Fasting Glucose, Hemoglobin A1c, and Triglyceride-Glucose Index on Cardiovascular Events in Type 2 Diabetes Mellitus.
Su, WY, Chen, SC, Huang, YT, Huang, JC, Wu, PY, Hsu, WH, Lee, MY
Nutrients. 2019;11(11)
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Cardiovascular disease generally refers to the narrowing or blockage of the arteries of the heart, which can lead to a heart attack or stroke and is the major cause of death in individuals with type 2 diabetes. Identifying individuals with type 2 diabetes who are at high risk of developing cardiovascular disease could ensure better management of these patients. This retrospective observational study of 3524 individuals with type 2 diabetes aimed to investigate if the amount of sugar found in the blood over the last few months, known as haemaglobin A1c (HbA1c) can predict cardiovascular disease in individuals with type 2 diabetes. In addition, the study looked at the triglyceride-glucose (TyG) index and its relationship to cardiovascular disease outcomes. The results showed that several factors were associated with cardiovascular disease, however of main note was that the TyG index and the amount of sugar in the blood following a fast were associated with increased cardiovascular events in individuals with type 2 diabetes, but HbA1c was not. It was concluded that TyG and the blood sugar level could be used to allow early identification and management of type 2 diabetics to prevent cardiovascular events. Clinicians could use this study to justify the use of measuring the TyG index and blood sugar levels as a predictor for cardiovascular events to ensure that patients are managed not only for type 2 diabetes but also to reduce their risk of cardiovascular events in the future.
Abstract
The triglyceride-glucose (TyG) index has been correlated with insulin resistance. We aim to investigate the role of the TyG index on cardiovascular (CV) events in type 2 diabetes mellitus and compare the roles of fasting glucose, hemoglobin A1c, and the TyG index in predicting CV events. This retrospective study enrolled 3524 patients with type 2 diabetes from the Kaohsiung Medical University Research Database in 2009 in this longitudinal study and followed them until 2015. The TyG index was calculated as log (fasting triglyceride level (mg/dL) × fasting glucose level (mg/dL)/2). CV events included myocardial infarction, unstable angina, stroke, hospitalization for coronary artery disease, peripheral artery disease, and CV-related death. The association between variables and CV events was assessed using a multivariable stepwise Cox proportional hazard analysis. Two hundred and fifteen CV events (6.1%) were recorded during a follow-up period of 5.93 years. The multivariable stepwise analysis showed that high fasting glucose (HR, 1.007; p < 0.001) and a high TyG index (HR, 1.521; p = 0.004) but not hemoglobin A1c or triglycerides were associated with a higher rate of CV events. Adding fasting glucose and the TyG index to the basic model improved the predictive ability of progression to a CV event (p < 0.001 and p = 0.018, respectively), over that of hemoglobin A1c (p = 0.084) and triglyceride (p = 0.221). Fasting glucose and the TyG index are useful parameters and stronger predictive factors than hemoglobin A1c and triglyceride for CV events and may offer an additional prognostic benefit in patients with type 2 diabetes.
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Effect of yerba mate and green tea on paraoxonase and leptin levels in patients affected by overweight or obesity and dyslipidemia: a randomized clinical trial.
Balsan, G, Pellanda, LC, Sausen, G, Galarraga, T, Zaffari, D, Pontin, B, Portal, VL
Nutrition journal. 2019;18(1):5
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Yerba mate is a popular tea-like beverage, traditionally consumed in Latin and South America. Yerba mate contains a range of plant compounds that may have beneficial effects on health, such as weight loss and antioxidant activity. This study aimed to evaluate the effect of the intake of yerba mate and green tea on serum levels of leptin, a hormone involved in regulating appetite, and paraoxonase-1 (PON-1), an enzyme that can destroy harmful oxidised fats in the blood. 142 overweight or obese adults aged 35-60 years, with abnormal levels of fats in the blood and no history of coronary artery disease took part in this controlled, randomised clinical trial. Participants drank 1 litre of either yerba mate, green tea or apple tea daily for eight weeks. Blood PON-1 and leptin levels were measured at the beginning and end of the study. The group drinking yerba mate showed a significant 9.7% increase in blood levels of PON-1, but no difference in leptin levels. The consumption of green tea resulted in no significant differences in the levels of PON-1 or leptin. The increase in PON-1 levels in the yerba mate group was significantly associated with increased levels of high-density lipoprotein (HDL-c - often called ‘good’ cholesterol). The authors concluded that drinking yerba mate increased antioxidant capacity by increasing blood levels of PON-1 and was positively associated with increased HDL-c, demonstrating a protective role of this beverage against thickening and hardening of the arteries.
Abstract
BACKGROUND This study aimed to evaluate the effect of the intake of yerba mate (YM) and green tea (GT) on serum levels of leptin and paraoxonase-1 (PON-1), compared to control. METHODS Controlled, randomized clinical trial (RCT) that evaluated 142 men and women affected by overweight or obesity aged 35-60 years, untreated dyslipidemia and no history of coronary artery disease. Participants were randomized to ingest 1000 mL GT, YM or apple tea (AT, control group) daily, during eight weeks. Serum PON-1 and leptin levels were analyzed by ELISA immunoassay at the beginning (baseline) and after eight weeks of intervention. RESULTS The intake of 1 l of YM/day resulted in significant increase in serum levels of PON-1 (9.7%; p = 0.005). The consumption of GT induced no significant difference in the levels of PON-1 (p = 0.154) and leptin (p = 0.783). Intergroup analysis showed a significant difference (p = 0.036) in the variation of PON-1 levels in the YM group when compared to GT and AT groups. In addition, the increase in PON-1 levels in the YM group was significantly associated with increased HDL-c (p = 0.004). CONCLUSIONS The intake of yerba mate increased the antioxidant capacity by increasing serum levels of PON-1 and was positively associated with increased HDL-c, stressing the protective role of this beverage against atherosclerotic diseases. GT intake had no significant effect on serum levels of PON-1 and leptin. TRIAL REGISTRATION This study is registered with ClinicalTrials.gov under protocol number NCT00933647.
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Comparison of two low-fat diets, differing in protein and carbohydrate, on psychological wellbeing in adults with obesity and type 2 diabetes: a randomised clinical trial.
Watson, NA, Dyer, KA, Buckley, JD, Brinkworth, GD, Coates, AM, Parfitt, G, Howe, PRC, Noakes, M, Murphy, KJ
Nutrition journal. 2018;17(1):62
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The psychological burden of living with type 2 diabetes (T2D) has far reaching effects, negatively impacting quality of life, physical health and emotional wellbeing. It has been suggested that health-related quality of life (HRQoL) changes in response to weight status however this has not yet been explored in individuals with T2D. The aim of this randomised controlled study was to compare the effects of high protein and high carbohydrate diets, combined with moderate intensity exercise, on psychological wellbeing and HRQoL in 61 overweight adults with T2D. Participants enrolled in a 12-week weight loss period followed by a 12-week weight maintenance phase and blood glucose levels and various quality of life factors were assessed. This trial found in overweight adults with T2D, improvements in several psychological wellbeing and HRQoL were seen in response to modest weight loss and improvements in blood sugar levels. Improvements were seen in both high protein and high carbohydrate group, though a high protein diet may be better for maintaining control of blood glucose levels thus improving feelings of vitality. Based on this study, the authors conclude that it is imperative to address and support the psychological aspects of patients managing T2D.
Abstract
BACKGROUND Although higher-protein diets (HP) can assist with weight loss and glycemic control, their effect on psychological wellbeing has not been established. The objective of this study was to compare the effects of a HP and a higher-carbohydrate diet (HC), combined with regular exercise, on psychological wellbeing both during weight loss (WL) and weight maintenance phases (WM). METHODS In a parallel RCT, 61 adults with T2D (mean ± SD: BMI 34.3 ± 5.1 kg/m2, aged 55 ± 8 years) consumed a HP diet (29% protein, 34% carbohydrate, 31% fat) or an isocaloric HC diet (21%:48%:24%), with moderate intensity exercise, for 12 weeks of WL and 12 weeks of WM. Secondary data evaluating psychological wellbeing was assessed using: Problems Areas in Diabetes (PAID); Diabetes-39 Quality of Life (D-39); Short Form Health Survey (SF-36); Perceived Stress Scale-10 (PSS-10) and the Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 0, 12 and 24 and evaluated with mixed models analysis. RESULTS Independent of diet, improvements for PAID; D-39 diabetes control; D-39 severity of diabetes; SF-36 physical functioning and SF-36 general health were found following WL (d = 0.30 to 0.69, P ≤ 0.04 for all) which remained after 12 weeks of WM. SF-36 vitality improved more in the HP group (group x time interaction P = 0.03). Associations were seen between HbA1c and D-39 severity of diabetes rating (r = 0.30, P = 0.01) and SF-36 mental health (r = - 0.32, P = 0.003) and between weight loss and PAID (r = 0.30, P = 0.01). CONCLUSION Several improvements in diabetes-related and general psychological wellbeing were seen similarly for both diets following weight loss and a reduction in HbA1c with most of these improvements remaining when weight loss was sustained for 12 weeks. A HP diet may provide additional increases in vitality. TRIAL REGISTRATION The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN 12613000008729 ) on 4 January 2013.
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The Effect of Low-Carbohydrate Diet on Glycemic Control in Patients with Type 2 Diabetes Mellitus.
Wang, LL, Wang, Q, Hong, Y, Ojo, O, Jiang, Q, Hou, YY, Huang, YH, Wang, XH
Nutrients. 2018;10(6)
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Dietary intervention is a strategy to manage diabetes mellitus, as it can reduce the burden on islet cells and thus improve blood glucose levels, lipid profiles, and cognitive status. The aim of the study was to find out the effectiveness of the ‘six-point formula’ and the effects of a low-fat diet and low-carbohydrate diet on hyperglycaemia. The study is a prospective, single-blind randomized controlled trial which recruited 56 participants with type 2 diabetes mellitus. The participants were randomly allocated to receive either a low-fat diet or a low-carbohydrate diet. Results show that HbA1c levels (the average blood glucose levels in the last 2 – 3 months) in low-carbohydrate diet decreased significantly compared to the low-fat diet. The body mass index and the total cholesterol levels of the participants following the low-carbohydrate diet also decreased. Authors conclude that a low-carbohydrate diet can improve blood glucose, regulate blood lipids, reduce body mass index and decrease insulin doses more than a low-fat diet in Chinese patients with type 2 diabetes mellitus.
Abstract
OBJECTIVE In China, a low-fat diet (LFD) is mainly recommended to help improve blood glucose levels in patients with type 2 diabetes mellitus (T2DM). However, a low-carbohydrate diet (LCD) has been shown to be effective in improving blood glucose levels in America and England. A few studies, primarily randomized controlled trials, have been reported in China as well. METHOD Firstly, we designed two 'six-point formula' methods, which met the requirements of LCD and LFD, respectively. Fifty-six T2DM patients were recruited and randomly allocated to the LCD group (n = 28) and the LFD group (n = 28). The LCD group received education about LCD's six-point formula, while the LFD group received education about LFD's six-point formula. The follow-up time was three months. The indicators for glycemic control and other metabolic parameters were collected and compared between the two groups. RESULTS Forty-nine patients completed the study. The proportions of calories from three macronutrients the patients consumed met the requirements of LCD and LFD. Compared to the LFD group, there was a greater decrease in HbA1c level in the LCD group (-0.63% vs. -0.31%, p < 0.05). The dosages of insulin and fasting blood glucoses (FBG) in the third month were lower than those at baseline in both groups. Compared with baseline values, body mass index (BMI) and total cholesterol (TC) in the LCD group were significantly reduced in the third month (p < 0.05); however, there were no statistically significant differences in the LFD group. CONCLUSIONS LCD can improve blood glucose more than LFD in Chinese patients with T2DM. It can also regulate blood lipid, reduce BMI, and decrease insulin dose in patients with T2DM. In addition, the six-point formula is feasible, easily operable, and a practical educational diet for Chinese patients with T2DM.
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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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Comparison of low calorie high protein and low calorie standard protein diet on waist circumference of adults with visceral obesity and weight cycling.
Witjaksono, F, Jutamulia, J, Annisa, NG, Prasetya, SI, Nurwidya, F
BMC research notes. 2018;11(1):674
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Obesity has become one of the world’s biggest health problem. Obese individuals with a history of repeated weight loss and regain (called weight cycling) have a higher risk of developing chronic disease and increased fat mass in every cycle. The objective of the study was to evaluate the effect of a low calorie high protein diet compared to a low calorie standard protein diet on waist circumference in adults with visceral obesity. The open, randomised clinical trial recruited 61 obese subjects who are older than 20 years of age and had a history of weight cycling. Participants were randomly assigned to one of the two diet groups; high protein or standard protein. Results showed that following a low-calorie diet resulted in waist circumference reduction thus reducing visceral fat. However, protein composition in the diet plan did not affect waist circumference reduction. Authors conclude that calorie restricted diets could be suggested in the treatment of visceral obesity. Macronutrient composition can be adjusted to meet the patient’s individual needs.
Abstract
OBJECTIVES Many individuals with visceral obesity who previously had succeeded in reducing body weight regain and this loss-gain cycle repeats several times which is called as weight cycling. We aimed to evaluate the effect of a low calorie high protein diet (HP) compared to a low calorie standard protein diet (SP) on waist circumference of visceral obese adults with history of weight cycling. RESULTS In this open-randomized clinical trial, participants were asked to follow dietary plan with reduction in daily caloric intake ranging from 500 to 1000 kcal from usual daily amount with minimum daily amount of 1000 kcal for 8 weeks and were divided in two groups: HP group with protein as 22-30% total calorie intake; and SP group with protein as 12-20% total calorie intake. There was a statistically significant difference (P < 0.001) between waist circumference before and after the dietary intervention among both groups. Meanwhile, there was no statistically significant difference in the mean reduction of waist circumference between HP and SP groups (P = 0.073). Taken together, the protein proportion does not significantly affected waist circumference. Trial registration ClinicalTrials.gov NCT03374150, 11 December 2017.
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Acute Endothelial Benefits of Fat Restriction over Carbohydrate Restriction in Type 2 Diabetes Mellitus: Beyond Carbs and Fats.
Barbosa-Yañez, RL, Dambeck, U, Li, L, Machann, J, Kabisch, S, Pfeiffer, AFH
Nutrients. 2018;10(12)
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The control of type 2 diabetes mellitus has become a global challenge. Cardiovascular disease is a major cause of mortality in type 2 diabetes. The aim of the study is to examine and compare the effect of a hypocaloric very low carbohydrate diet versus hypocaloric low-fat diet on vascular function and visceral adipose tissue in type 2 diabetic patients. The study is a randomised parallel group intervention study with adult type 2 diabetes patients with an age range between 42 and 76 years. Results show that both dietary strategies effectively reduced body weight, total adipose tissue, visceral adipose tissue and lipid accumulation in the liver. However, participants following the low-fat diet experienced greater vascular function enhancements. Authors conclude that low-fat diet elicited advantageous effects on vascular function in patients with type 2 diabetes.
Abstract
BACKGROUND Cardiovascular diseases (CVD) are the major cause of mortality in type 2 diabetes patients (T2DM). The causes are embedded in a complex interplay between excess body fat, insulin resistance and serum lipid anomalies. Endothelial homeostasis is strongly affected by this pathogenic network. Even though metabolic changes and weight loss improve vascular endothelial function, the effect of different dietary approaches is still uncertain for type 2 diabetes patients. OBJECTIVE We aimed to compare the acute effects of a hypocaloric very low carbohydrate (VLC) diet versus a hypocaloric low fat (LF) diet on flow mediated dilation (FMD), intrahepatic lipid (IHL) accumulation and visceral adipose tissue as independent risk factors of CVD in T2DM patients. DESIGN 36 T2DM patients (age 63 ± 8 years, 60% females) were randomly assigned to the VLC diet (4⁻10% of total energy intake (E)) or to the LF diet (<30% E) for 3 weeks. Endothelial function was assessed by the flow mediated dilation (FMD) method. Adipose tissue depots and IHL were determined by magnetic resonance. RESULTS Both dietary strategies reduced body weight, body fat content and IHL. Unexpectedly, the LF group experienced significantly greater enhancement of FMD, compared to the VLC group. The FMD showed a positive correlation with protein intake and fat intake in the LF group, while it revealed a negative correlation with protein intake in the VLC diet group. CONCLUSIONS Reduction of total and hepatic adiposity was shown to be successful using either the VLC or LF hypocaloric diets, however, improvements in FMD may be related to the interplay of fat and protein intake.
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Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.
Johansen, MY, MacDonald, CS, Hansen, KB, Karstoft, K, Christensen, R, Pedersen, M, Hansen, LS, Zacho, M, Wedell-Neergaard, AS, Nielsen, ST, et al
JAMA. 2017;318(7):637-646
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First-line treatment of Type 2 diabetes includes diet, physical activity, and weight loss prior to or in parallel with initiation of medication. The aim of this study was to examine whether an intensive lifestyle intervention results in equivalent blood sugar control compared with standard care. A secondary aim was to test whether an intensive lifestyle intervention leads to a reduction in glucose-lowering medication in participants with Type 2 diabetes. The study was a randomized, assessor-blind clinical study of 98 adults with Type 2 diabetes diagnosed for less than 10 years. The participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34). Results show that an intensive lifestyle intervention did not achieve comparable blood sugar control in comparison with standard care, however, the former led to a substantial and parallel reduction in glucose-lowering medication. The authors conclude that even though a lifestyle intervention compared to standard care did not result in the expected glycaemic control, it was still in a direction consistent with benefit.
Abstract
Importance: It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes. Objective: To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes. Design, Setting, and Participants: Randomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016). Ninety-eight adult participants with non-insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included. Participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34). Interventions: All participants received standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months. Main Outcomes and Measures: Primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ±0.4% based on the intention-to-treat population. Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication. Results: Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference in change of -0.26% [95% CI, -0.52% to -0.01%]), not meeting the criteria for equivalence (P = .15). Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1 percentage points [95% CI, 28.6-65.3]). There were 32 adverse events (most commonly musculoskeletal pain or discomfort and mild hypoglycemia) in the lifestyle group and 5 in the standard care group. Conclusions and Relevance: Among adults with type 2 diabetes diagnosed for less than 10 years, a lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings. Trial Registration: clinicaltrials.gov Identifier: NCT02417012.
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Thyroid hormones and changes in body weight and metabolic parameters in response to weight loss diets: the POUNDS LOST trial.
Liu, G, Liang, L, Bray, GA, Qi, L, Hu, FB, Rood, J, Sacks, FM, Sun, Q
International journal of obesity (2005). 2017;41(6):878-886
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The role of thyroid hormones in diet-induced weight loss and subsequent weight regain is largely unknown. The aim of this study was to examine the associations between thyroid hormones and changes in body weight and resting metabolic rate (RMR) in adults on a calorie-restricted diet. Data analysis was conducted among 569 overweight and obese adults with normal thyroid function participating in the 2-year Prevention of Obesity Using Novel Dietary Strategies (POUNDS) LOST clinical trial. Participants were assigned to diets that represented a reduced caloric intake of 750 kcal/day from estimated energy needs. Changes in body weight and RMR were assessed during the 2-year intervention. Thyroid hormones (free triiodothyronine (T3), free thyroxine (T4), total T3, total T4 and thyroid-stimulating hormone (TSH)), anthropometric measurements and biochemical parameters were assessed at baseline, 6 months and 24 months. Participants lost an average of 6.6 kg of body weight during the first 6 months and subsequently regained an average of 2.7 kg of body weight over the remaining period from 6 to 24 months. Baseline free T3, total T3 and free T4 were associated with baseline body weight, body mass index and RMR. Total T4 and TSH were not associated with these parameters. Higher baseline free T3 and free T4 levels were significantly associated with a greater weight loss during the first 6 months. Thyroid hormones did not predict weight regain in 6-24 months. In addition, changes in free T3 and total T3 levels were positively associated with changes in body weight, RMR, body fat mass, blood pressure, glucose, insulin, triglycerides and leptin at 6 months and 24 months. The authors concluded that on a reduced-calorie diet, higher baseline free T3 and free T4 predicted more weight loss, but not weight regain among overweight and obese adults with normal thyroid function. These findings reveal a role of thyroid hormones in body weight regulation and may help identify individuals more responsive to weight loss diets.
Abstract
BACKGROUND The role of thyroid hormones in diet-induced weight loss and subsequent weight regain is largely unknown. OBJECTIVES To examine the associations between thyroid hormones and changes in body weight and resting metabolic rate (RMR) in a diet-induced weight loss setting. SUBJECTS/METHODS Data analysis was conducted among 569 overweight and obese participants aged 30-70 years with normal thyroid function participating in the 2-year Prevention of Obesity Using Novel Dietary Strategies (POUNDS) LOST randomized clinical trial. Changes in body weight and RMR were assessed during the 2-year intervention. Thyroid hormones (free triiodothyronine (T3), free thyroxine (T4), total T3, total T4 and thyroid-stimulating hormone (TSH)), anthropometric measurements and biochemical parameters were assessed at baseline, 6 months and 24 months. RESULTS Participants lost an average of 6.6 kg of body weight during the first 6 months and subsequently regained an average of 2.7 kg of body weight over the remaining period from 6 to 24 months. Baseline free T3 and total T3 were positively associated, whereas free T4 was inversely associated, with baseline body weight, body mass index and RMR. Total T4 and TSH were not associated with these parameters. Higher baseline free T3 and free T4 levels were significantly associated with a greater weight loss during the first 6 months (P<0.05) after multivariate adjustments including dietary intervention groups and baseline body weight. Comparing extreme tertiles, the multivariate-adjusted weight loss±s.e. was -3.87±0.9 vs -5.39±0.9 kg for free T3 (Ptrend=0.02) and -4.09±0.9 vs -5.88±0.9 kg for free T4 (Ptrend=0.004). The thyroid hormones did not predict weight regain in 6-24 months. A similar pattern of associations was also observed between baseline thyroid hormones and changes in RMR. In addition, changes in free T3 and total T3 levels were positively associated with changes in body weight, RMR, body fat mass, blood pressure, glucose, insulin, triglycerides and leptin at 6 months and 24 months (all P<0.05). CONCLUSIONS In this diet-induced weight loss setting, higher baseline free T3 and free T4 predicted more weight loss, but not weight regain among overweight and obese adults with normal thyroid function. These findings reveal a novel role of thyroid hormones in body weight regulation and may help identify individuals more responsive to weight loss diets.