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An Energy-Reduced Mediterranean Diet, Physical Activity, and Body Composition: An Interim Subgroup Analysis of the PREDIMED-Plus Randomized Clinical Trial.
Konieczna, J, Ruiz-Canela, M, Galmes-Panades, AM, Abete, I, Babio, N, Fiol, M, Martín-Sánchez, V, Estruch, R, Vidal, J, Buil-Cosiales, P, et al
JAMA network open. 2023;6(10):e2337994
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The Mediterranean diet (MedDiet), which focuses on whole grains, lean meat, fruits, vegetables, and low amounts of minimally processed foods has been shown in previous research to improve body composition and decrease fat storage around the middle. This randomised control trial of 1556 older adults aimed to determine the effects of combining a 30% lower energy version of the MedDiet in combination with physical exercise on body composition. After 3 years, the results showed that compared to a normal MedDiet without exercise, the lower energy version in combination with exercise improved body composition by decreasing total fat, and the fat stored around the organs and increasing muscle mass. However, benefits were more pronounced after 1 year and decreased slightly at 3 years. It was concluded that a low energy MedDiet in combination with physical activity may be able to improve the body composition of overweight and older adults with obesity. This study could be used by healthcare professionals to recommend a low energy MedDiet to older adults to promote weight loss, whilst attenuating muscle loss associated with ageing.
Expert Review
Conflicts of interest:
None
Take Home Message:
- The addition of exercise to an energy-reduced diet, which focuses on whole grains, healthy fats, lean protein, and fruits and vegetables can emphasise positive effects on body composition in older adults.
- However, there is a loss of lean mass associated with this type of diet (contrary to author conclusions) and measures should be taken to monitor and increase protein intake to prevent or limit this loss.
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
This study aimed to determine the long-term effects of an energy reduced MedDiet in combination with physical activity on body composition.
Methods
- This is a predetermined 3-year interim analysis of a 6-year single-blind, randomised control trial of 1556 individuals aged 55-75 who are overweight or obese with metabolic syndrome.
- 760 individuals on 30% energy reduced MedDiet with limited processed foods, plus 45 minutes walking 6 days per week and behavioural and motivational support. [Intervention group]
- 761 on standard MedDiet without physical activity. [Control]
Results
Within group comparisons showed that individuals in the intervention group lost (P value represents baseline vs year 3):
- Total fat mass percentage (1-year vs baseline, −1.14%; 95% CI, −1.32% to −0.96%; 3-year vs baseline, −0.52%; 95% CI, −0.71% to −0.33% P=<0.001)
- Absolute visceral fat (1-year vs baseline, −154 g; 95% CI, −191 to −116 g; 3-year vs baseline, −75.1 g, 95% CI, −115 to −35.3 g P=<0.001)
- Absolute total fat after 1 year (mean change at 1 year vs baseline, −1677 g; 95% CI, −1930 to −1424 g) but regained some at year 3 (mean change at 3 years vs baseline, −1018 g; 95% CI, −1280 to −756 g P=<0.001)
- Absolute lean mass (mean change at 1 year vs baseline −300 g; 95% CI, −439 to −162 g) with further losses at year 3 (−626 g; 95% CI, −770 to −483 g P=0.001).
Within group comparisons also showed significantly increased:
- Total lean mass percentage, which was greater at year 1 than year 3 (1-year vs baseline, 1.07%; 95%CI, 0.90%-1.25%; 3-year vs baseline, 0.47%; 95% CI, 0.29%-0.65% P=<0.001).
As a result of total fat loss and some lean mass in the intervention group, the lean:fat mass ratio improved and was unchanged in the control group (between group differences (P=<0.001).
Compared to women, men may find the MedDiet + exercise more beneficial as it was shown that body composition changes were slightly more pronounced in men.
Conclusion
An energy-reduced MedDiet plus exercise emphasised positive changes to body composition compared to standard MedDiet in older adults who are overweight or have obesity.
Clinical practice applications:
- The recommendation of a reduced energy MedDiet in combination with physical activity to older people who are overweight or obese may improve body composition.
- Although lean mass loss slowed between years 1 and 3, other practices should be employed to attenuate the loss of lean mass associated with an energy-reduced MedDiet and ageing.
Considerations for future research:
- The research has not yet concluded but when it does, it will address the incidence of cardiovascular disease along with body composition changes.
- It will also look at long-term effects of the diet to determine longevity.
- Future research could focus on how to limit lean mass loss through the possibility of changing the type of exercise that accompanies the MedDiet.
Abstract
IMPORTANCE Strategies targeting body composition may help prevent chronic diseases in persons with excess weight, but randomized clinical trials evaluating lifestyle interventions have rarely reported effects on directly quantified body composition. OBJECTIVE To evaluate the effects of a lifestyle weight-loss intervention on changes in overall and regional body composition. DESIGN, SETTING, AND PARTICIPANTS The ongoing Prevención con Dieta Mediterránea-Plus (PREDIMED-Plus) randomized clinical trial is designed to test the effect of the intervention on cardiovascular disease prevention after 8 years of follow-up. The trial is being conducted in 23 Spanish research centers and includes men and women (age 55-75 years) with body mass index between 27 and 40 and metabolic syndrome. The trial reported herein is an interim subgroup analysis of the intermediate outcome body composition after 3-year follow-up, and data analysis was conducted from February 1 to November 30, 2022. Of 6874 total PREDIMED-Plus participants, a subsample of 1521 individuals, coming from centers with access to a dual energy x-ray absorptiometry device, underwent body composition measurements at 3 time points. INTERVENTION Participants were randomly allocated to a multifactorial intervention based on an energy-reduced Mediterranean diet (MedDiet) and increased physical activity (PA) or to a control group based on usual care, with advice to follow an ad libitum MedDiet, but no physical activity promotion. MAIN OUTCOMES AND MEASURES The outcomes (continuous) were 3-year changes in total fat and lean mass (expressed as percentages of body mass) and visceral fat (in grams), tested using multivariable linear mixed-effects models. Clinical relevance of changes in body components (dichotomous) was assessed based on 5% or more improvements in baseline values, using logistic regression. Main analyses were performed in the evaluable population (completers only) and in sensitivity analyses, multiple imputation was performed to include data of participants lost to follow-up (intention-to-treat analyses). RESULTS A total of 1521 individuals were included (mean [SD] age, 65.3 [5.0] years; 52.1% men). In comparison with the control group (n=761), participants in the intervention arm (n=760) showed greater reductions in the percentage of total fat (between group differences after 1-year, -0.94% [95% CI, -1.19 to -0.69]; 3 years, -0.38% [95% CI, -0.64 to -0.12] and visceral fat storage after 1 year, -126 g [95% CI, -179 to -73.3 g]; 3 years, -70.4 g [95% CI, -126 to -15.2 g] and greater increases in the percentage of total lean mass at 1 year, 0.88% [95% CI, 0.63%-1.12%]; 3-years 0.34% [95% CI, 0.09%-0.60%]). The intervention group was more likely to show improvements of 5% or more in baseline body components (absolute risk reduction after 1 year, 13% for total fat mass, 11% for total lean mass, and 14% for visceral fat mass; after 3-years: 6% for total fat mass, 6% for total lean mass, and 8% for visceral fat mass). The number of participants needed to treat was between 12 and 17 to attain at least 1 individual with possibly clinically meaningful improvements in body composition. CONCLUSIONS AND RELEVANCE The findings of this trial suggest a weight-loss lifestyle intervention based on an energy-reduced MedDiet and physical activity significantly reduced total and visceral fat and attenuated age-related losses of lean mass in older adults with overweight or obesity and metabolic syndrome. Continued follow-up is warranted to confirm the long-term consequences of these changes on cardiovascular clinical end points. TRIAL REGISTRATION isrctn.org Identifier: ISRCTN89898870.
2.
Lifestyle factors and visceral adipose tissue: Results from the PREDIMED-PLUS study.
Galmes-Panades, AM, Konieczna, J, Abete, I, Colom, A, Rosique-Esteban, N, Zulet, MA, Vázquez, Z, Estruch, R, Vidal, J, Toledo, E, et al
PloS one. 2019;14(1):e0210726
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Excess visceral adipose tissue (VAT, abdominal fat) is a risk factor for developing cardiovascular disease, type 2 diabetes mellitus and all cause mortality. Lifestyle factors, including diet and physical activity, are associated with VAT. This cross-sectional study evaluated the association between different levels of physical activity (PA), adherence to an energy-restricted Mediterranean diet and sedentary lifestyle with VAT in older people with overweight/obesity and metabolic syndrome. Data were taken from an ongoing randomised study evaluating the effect of a weight loss programme based on an energy-restricted Mediterranean diet, promotion of physical activity and behavioural support compared to usual care consisting of advice on an energy-unrestricted Mediterranean diet only. Total and moderate-to-vigorous physical activity and muscle strength were inversely, and sedentary behaviour was positively associated with VAT. There was no statistically significant association between VAT and light exercise, adherence to the energy-reduced Mediterranean diet and watching TV.
Abstract
BACKGROUND Visceral adipose tissue (VAT) is a strong predictor of cardiometabolic health, and lifestyle factors may have a positive influence on VAT depot. This study aimed to assess the cross-sectional associations between baseline levels of physical activity (PA), sedentary behaviours (SB) and adherence to the Mediterranean diet (MedDiet) with VAT depot in older individuals with overweight/obesity and metabolic syndrome. METHODS Baseline data of the PREDIMED-Plus study including a sample of 1,231 Caucasian men and women aged 55-75 years were used. Levels of leisure-time PA (total, light, and moderate-to-vigorous, in METs·min/day) and SB (total and TV-viewing, in h/day) were evaluated using validated questionnaires. Adherence to the MedDiet was evaluated using a 17-item energy-restricted MedDiet (erMedDiet) screener. The chair-stand test was used to estimate the muscle strength. VAT depot was assessed with DXA-CoreScan. Multivariable adjusted linear regression models were used to evaluate the association between lifestyle factors and VAT. For the statistics we had used multiadjusted linear regression models. RESULTS Total leisure-time PA (100 METs·min/day: β -24.3g, -36.7;-11.9g), moderate-to-vigorous PA (β -27.8g, 95% CI -40.8;-14.8g), chair-stand test (repeat: β -11.5g, 95% CI -20.1;-2.93g) were inversely associated, and total SB (h/day: β 38.2g, 95% CI 14.7;61.7) positively associated with VAT. Light PA, TV-viewing time and adherence to an erMedDiet were not significantly associated with VAT. CONCLUSIONS In older adults with overweigh/obesity and metabolic syndrome, greater PA, muscle strength, and lower total SB were associated with less VAT depot. In this study, adherence to an erMedDiet was not associated with lower VAT.
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Effects of Intermittent Energy Restriction Combined with a Mediterranean Diet on Reducing Visceral Adiposity: A Randomized Active Comparator Pilot Study.
Panizza, CE, Lim, U, Yonemori, KM, Cassel, KD, Wilkens, LR, Harvie, MN, Maskarinec, G, Delp, EJ, Lampe, JW, Shepherd, JA, et al
Nutrients. 2019;11(6)
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Excess adiposity is known to contribute to many metabolic diseases. Intermittent energy restriction (IER) has emerged as a favourable method of calorie reduction, and combining IER with the Mediterranean diet has shown promising results for reducing body fat and improving insulin resistance. The aim of this pilot study was to explore efficacy of an IER and Mediterranean diet in adiposity reduction in 60 Japanese Americans. Participants were randomised to either consume the IER + Mediterranean diet (22) or a control anti-hypertension diet (26) for 12 weeks. At baseline and 12-weeks, visceral adipose tissue and total fat mass were measured. Phone check-ins were completed weekly for the 12-weeks and both groups had equivalent dietetic support. This study found significant reductions in total fat mass in the IER + Mediterranean group compared with the control group, and found diet adherence to be high. Based on these results, the authors conclude the IER and Mediterranean diet combined can lower total adiposity and potentially improve liver function among Japanese Americans.
Abstract
Intermittent energy restriction combined with a Mediterranean diet (IER+MED) has shown promise to reduce body fat and insulin resistance. In the Multiethnic Cohort Adiposity Phenotype Study, Japanese Americans had the highest visceral adipose tissue (VAT) when adjusting for total adiposity. We conducted this pilot study to demonstrate feasibility and explore efficacy of following IER+MED for 12 weeks to reduce VAT among East Asians in Hawaii. Sixty volunteers (aged 35-55, BMI 25-40 kg/m2, VAT ≥ 90 cm2 for men and ≥ 80 cm2 for women) were randomized to IER+MED (two consecutive days with 70% energy restriction and 5 days euenergetic MED) or an active comparator (euenergetic Dietary Approaches to Stop Hypertension (DASH) diet). Participants and clinic staff (except dietitians) were blinded to group assignments. IER+MED had significantly larger reductions in DXA-measured VAT and total fat mass (-22.6 ± 3.6 cm2 and -3.3 ± 0.4 kg, respectively) vs. DASH (-10.7 ± 3.5 cm2 and -1.6 ± 0.4 kg) (p = 0.02 and p = 0.005). However, after adjusting for total fat mass, change in VAT was not statistically different between groups; whereas, improvement in alanine transaminase remained significantly greater for IER+MED vs. DASH (-16.2 ± 3.8 U/L vs. -4.0 ± 3.6 U/L, respectively, p = 0.02). Attrition rate was 10%, and participants adhered well to study prescriptions with no reported major adverse effect. Results demonstrate IER+MED is acceptable, lowers visceral and total adiposity among East Asian Americans, and may improve liver function more effectively than a healthful diet pattern. ClinicalTrials.gov Identifier: NCT03639350.
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A Randomized Study of the Effects of Additional Fruit and Nuts Consumption on Hepatic Fat Content, Cardiovascular Risk Factors and Basal Metabolic Rate.
Agebratt, C, Ström, E, Romu, T, Dahlqvist-Leinhard, O, Borga, M, Leandersson, P, Nystrom, FH
PloS one. 2016;11(1):e0147149
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Fruits and vegetables intake has been advocated to improve blood lipids profile and reduce risk of cardiovascular disease, diabetes and cancer. However, a low fat diet rich in fruits and vegetables has showed no effect on cardiovascular disease and cancer in a large randomized American trial. This might be due to the high sugar content in fruits, particularly fructose. The aim of this study was to compare the effects of adding either fruits or nuts to the diet of 30 healthy non-obese individuals on liver fat, metabolic rate and cardiovascular risk markers. Authors concluded that the trial only showed small effects on cardiovascular risk factors. Nevertheless, there was a significant change in lipoprotein (fats that transport fats in the blood) levels between the two groups, which tends to give an advantage to the consumption of nuts over fruits. They deduced that increased intake of fruits doesn’t negatively impact cardiovascular disease risk factors in healthy non-obese individuals. However, further research needs to evaluate the effects on obese and insulin-resistant participants.
Abstract
BACKGROUND Fruit has since long been advocated as a healthy source of many nutrients, however, the high content of sugars in fruit might be a concern. OBJECTIVES To study effects of an increased fruit intake compared with similar amount of extra calories from nuts in humans. METHODS Thirty healthy non-obese participants were randomized to either supplement the diet with fruits or nuts, each at +7 kcal/kg bodyweight/day for two months. Major endpoints were change of hepatic fat content (HFC, by magnetic resonance imaging, MRI), basal metabolic rate (BMR, with indirect calorimetry) and cardiovascular risk markers. RESULTS Weight gain was numerically similar in both groups although only statistically significant in the group randomized to nuts (fruit: from 22.15 ± 1.61 kg/m(2) to 22.30 ± 1.7 kg/m(2), p = 0.24 nuts: from 22.54 ± 2.26 kg/m(2) to 22.73 ± 2.28 kg/m(2), p = 0.045). On the other hand BMR increased in the nut group only (p = 0.028). Only the nut group reported a net increase of calories (from 2519 ± 721 kcal/day to 2763 ± 595 kcal/day, p = 0.035) according to 3-day food registrations. Despite an almost three-fold reported increased fructose-intake in the fruit group (from 9.1 ± 6.0 gram/day to 25.6 ± 9.6 gram/day, p<0.0001, nuts: from 12.4 ± 5.7 gram/day to 6.5 ± 5.3 gram/day, p = 0.007) there was no change of HFC. The numerical increase in fasting insulin was statistically significant only in the fruit group (from 7.73±3.1 mIE/L to 8.81±2.9 mIE/L, p = 0.018, nuts: from 7.29±2.9 mIE/L to 8.62±3.0 mIE/L, p = 0.14). Levels of vitamin C increased in both groups while α-tocopherol/cholesterol-ratio increased only in the fruit group. CONCLUSIONS Although BMR increased in the nut-group only this was not linked with differences in weight gain between groups which potentially could be explained by the lack of reported net caloric increase in the fruit group. In healthy non-obese individuals an increased fruit intake seems safe from cardiovascular risk perspective, including measurement of HFC by MRI. TRIAL REGISTRATION ClinicalTrials.gov NCT02227511.