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Vitamin D supplementation and exercise for improving physical function, body composition and metabolic health in overweight or obese older adults with vitamin D deficiency: a pilot randomized, double-blind, placebo-controlled trial.
Mesinovic, J, Rodriguez, AJ, Cervo, MM, Gandham, A, Xu, CLH, Glavas, C, de Courten, B, Zengin, A, Ebeling, PR, Scott, D
European journal of nutrition. 2023;62(2):951-964
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Overweight and obese older adults are at increased risk for vitamin D deficiency, which is associated with poor metabolic and musculoskeletal health, unfavourable body composition, and attenuated responses to exercise. The aim of this study was to determine whether, compared with placebo, vitamin D3 supplementation (4000 IU/day) taken prior to and during a 12-week exercise program improves physical function, body composition or metabolic health, in overweight or obese older adults with vitamin D deficiency. This study is a 24-week parallel-group, double-blind, placebo-controlled pilot randomised controlled trial. Fifty overweight or obese participants were enrolled for the study, and randomised to either 4000 IU/day of oral vitamin D3 or identical placebo. Results demonstrated that 4000 IU/day vitamin D3 supplementation: - did not affect gait speed when taken with or without exercise, - helped achieve optimal serum 25-hydroxyvitamin D levels and decreased waist circumference (compared with placebo) following multi-modal exercise. - taken alone without exercise reduced stair climb times. However, vitamin D3 supplementation did not have any beneficial effects on other biochemical, body composition or physical function parameters when taken alone or during exercise. Authors conclude that future studies should focus on populations with moderate or severe vitamin D deficiency as they are more likely to experience therapeutic benefits from vitamin D supplementation.
Abstract
PURPOSE Vitamin D supplementation may have non-skeletal health benefits and enhance exercise responsiveness, particularly in those with low vitamin D levels. We determined whether, compared with placebo, vitamin D supplementation taken prior to and during a 12-week exercise program improves physical function, body composition or metabolic health, in overweight and obese older adults with vitamin D deficiency. METHODS Fifty overweight or obese older adults (mean ± SD age: 60 ± 6 years; BMI 30.6 ± 5.7 kg/m2) with vitamin D deficiency (25-hydroxyvitamin D [25(OH)D] < 50 nmol/L) were recruited. Participants were randomly allocated to receive either vitamin D3 (4000 IU/day) or matching placebo for 24 weeks. Between weeks 12 and 24, all participants completed multi-modal exercise three days per week while continuing with vitamin D/placebo. Mean changes in physical function (primary outcome: gait speed), body composition and biochemical parameters at weeks 12 and 24 were compared between groups. RESULTS Vitamin D supplementation, with or without exercise, had no effect on gait speed. From baseline to week 12, vitamin D supplementation increased serum 25(OH)D levels (placebo: 2.5 ± 14.7 nmol/L; treatment: 43.4 ± 18.4 nmol/L; P < 0.001) and reduced stair climb times (placebo: 0.3 ± 1.0 s; treatment: - 0.2 ± 1.0 s; P = 0.046). From 12 to 24 weeks, vitamin D supplementation combined with exercise decreased waist circumference (placebo: 1.3 ± 7.3 cm; treatment: - 3.0 ± 6.1 cm; P = 0.02) and waist-to-hip ratio (placebo: 0.01 ± 0.05; treatment: - 0.03 ± 0.05; P = 0.01) relative to placebo. Vitamin D supplementation, with or without exercise, had no effect on other physical function, body composition or metabolic health outcomes. CONCLUSION Vitamin D supplementation had no effect on most physical function, body composition or metabolic health parameters when taken alone, or during exercise, in overweight or obese older adults with vitamin D deficiency. Vitamin D-related improvements in stair climb times and waist circumference suggest that future trials should explore the effects of vitamin D on muscle power, and its effects on body composition when combined with exercise, in populations with moderate or severe vitamin D deficiency.
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Resistance Exercise Training Increases Muscle Mass and Strength in Prostate Cancer Patients on Androgen Deprivation Therapy.
Houben, LHP, Overkamp, M, VAN Kraaij, P, Trommelen, J, VAN Roermund, JGH, DE Vries, P, DE Laet, K, VAN DER Meer, S, Mikkelsen, UR, Verdijk, LB, et al
Medicine and science in sports and exercise. 2023;55(4):614-624
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Androgen deprivation therapy (ADT) forms the cornerstone in the treatment of localised high-risk, locally advanced, and metastatic prostate cancer (PCa). The hypothesis of this study was that protein supplementation augments the benefits of prolonged resistance exercise training to attenuate the decline in muscle mass, reduce fat mass accrual, and increase strength and physical performance in PCa patients on ADT. This study is a multicentre partly randomised controlled trial, comparing two intervention groups with a separately recruited control group. One hundred and twenty-six patients were included, and ninety-six patients finished the study. Results show that 20 week of resistance exercise training was feasible, safe, and well tolerated, and effectively counteracted the negative effect of ADT treatment on body composition, muscle mass, leg strength, and aerobic capacity in men with advanced PCa. Protein supplementation did not further augment the benefits of resistance exercise training. Authors conclude that protein supplementation is not required to further augment gains in muscle mass and strength after resistance exercise training in PCa patients who habitually consume ample protein.
Abstract
PURPOSE This study aimed to assess the effects of 20 wk resistance exercise training with or without protein supplementation on body composition, muscle mass, muscle strength, physical performance, and aerobic capacity in prostate cancer patients receiving androgen deprivation therapy (ADT). METHODS Sixty prostate cancer patients receiving ADT were randomly assigned to perform 20 wk of resistance exercise training with supplementation of 31 g whey protein (EX + PRO, n = 30) or placebo (EX + PLA, n = 30), consumed immediately after exercise and every night before sleep. A separate control group (CON, n = 36) only received usual care. At baseline and after 20 wk, body composition (dual-energy x-ray absorptiometry), muscle mass (computed tomography scan), muscle strength (1-repetition maximum strength tests), physical performance (Timed Up and Go Test, 30-Second Chair Stand Test, and Stair Climb Test), aerobic capacity (cardiopulmonary exercise test), and habitual dietary intake (food diary) were assessed. Data were analyzed using a two-factor repeated-measures ANOVA. RESULTS Over time, muscle mass and strength increased in EX + PRO and EX + PLA and decreased in CON. Total fat mass and fat percentage increased in EX + PRO and CON, but not in EX + PLA. Physical performance did not significantly change over time in either group. Aerobic capacity was maintained in EX + PLA, but it decreased in EX + PRO and CON. Habitual protein intake (without supplements) averaged >1.0 g·kg body weight -1 ·d -1 , with no differences over time or between groups. CONCLUSIONS In prostate cancer patients, resistance exercise training counteracts the adverse effects of ADT on body composition, muscle mass, muscle strength, and aerobic capacity, with no additional benefits of protein supplementation.
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The efficacy of morning versus evening exercise for weight loss: A randomized controlled trial.
Brooker, PG, Gomersall, SR, King, NA, Leveritt, MD
Obesity (Silver Spring, Md.). 2023;31(1):83-95
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Despite considerable efforts to promote a healthy lifestyle, rates of overweight and obesity are continuing to rise worldwide, and obesity is now considered a pandemic. Although dietary intervention is the most effective lifestyle intervention for weight loss, exercise plays an important role in weight management. The aim of this study was to investigate the influence of a 12-week exercise programme, performed in either the morning or evening, on weight loss, cardiometabolic health risk factors, and components of energy balance in inactive adults with overweight and obesity. This study is a three-armed randomised controlled trial. Participants allocated to the two intervention conditions were prescribed 250 minutes per week of self-paced aerobic (treadmill-based) exercise for 12 weeks. Results show that there was no compelling evidence to support or encourage exercise exclusively at a particular time of day for weight loss. However, there were improvements in cardiometabolic health, such as weight reduction and increased cardiorespiratory fitness, increased levels of physical activity, and positive changes to dietary intake in both intervention groups. Following the intervention, both exercise groups continued to lose weight, and the improvements in cardiorespiratory fitness were sustained. Authors conclude that consistent reporting of time of day of exercise interventions among high-quality studies would significantly contribute to the literature and provide critical insight into the relative importance (or lack thereof) of prescribing exercise at a particular time of day.
Abstract
OBJECTIVE The aim of this study was to investigate the influence of morning versus evening exercise on weight loss, cardiometabolic health, and components of energy balance. METHODS A total of 100 inactive adults with overweight or obesity were randomized to morning exercise (AMEx; 06:00-09:00), evening exercise (PMEx; 16:00-19:00), or wait-list control (CON). AMEx and PMEx were prescribed 250 min·wk-1 of self-paced aerobic exercise for 12 weeks. Anthropometry and body composition, physical activity, and dietary intake were assessed at baseline, 6 weeks, and 12 weeks. Cardiorespiratory fitness (V̇O2 peak), resting metabolic rate, and blood markers were assessed at baseline and 12 weeks. Body composition and V̇O2 peak were also measured at 3- and 6-month follow-up. RESULTS AMEx and PMEx lost weight during the intervention (mean [SD], AMEx, -2.7 [2.5] kg, p < 0.001; PMEx, -3.1 [3.4] kg, p < 0.001). V̇O2 peak significantly increased in both intervention groups, and these changes were different from CON (AMEx, +4.7 mL·kg-1 ·min-1 , p = 0.034; PMEx, +4.2 mL·kg-1 ·min-1 , p = 0.045). There were no between-group differences for resting metabolic rate or physical activity. At 12 weeks, total energy intake was significantly reduced in both AMEx and PMEx versus CON (AMEx, -3974 kJ, p < 0.001; PMEx, -3165 kJ, p = 0.001). CONCLUSIONS Adults with overweight and obesity experience modest weight loss in response to an exercise program, but there does not appear to be an optimal time to exercise.
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Effects of a 2-year exercise training on neuromuscular system health in older individuals with low muscle function.
Monti, E, Tagliaferri, S, Zampieri, S, Sarto, F, Sirago, G, Franchi, MV, Ticinesi, A, Longobucco, Y, Adorni, E, Lauretani, F, et al
Journal of cachexia, sarcopenia and muscle. 2023;14(2):794-804
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Ageing is accompanied by a progressive decline in muscle mass and functionality, associated with an increased likelihood of adverse outcomes including falls, fractures, physical disability and mortality, possibly leading to a clinical syndrome known as sarcopenia. Among the causes of sarcopenia, motoneuron and neuromuscular junction (NMJ) degeneration have been proposed as key determinants. The aim of this study was to investigate the effects of a 2-year multimodal training intervention involving aerobic, strength and balance exercises on muscle mass and function, motoneuronal and NMJ health in a population of older individuals classified as sarcopenic. This study was a randomised controlled trial which enrolled 45 sarcopenic participants (34 females and 11 males) who were randomly assigned to one of the two groups: intervention or control group. Results show that the 2-year multimodal training intervention seemingly preserved NMJ stability, preventing serum C-terminal agrin fragment (CAF) [a biomarker of muscle wasting and weakness] concentration rise in the intervention group, although this biomarker increased significantly only in the control group. Conversely, neurofilament light chain (NfL) [clinical biomarker of many neurodegenerative diseases] concentration did not change in either group. Finally, improvements of physical performance were correlated with changes of serum biomarkers of NMJ stability. Authors conclude that a 2-year multimodal training intervention including aerobic, strength and balance exercises is effective for preventing CAF concentration increments, suggesting a positive effect on NMJ stability.
Abstract
BACKGROUND Ageing is accompanied by a progressive loss of skeletal muscle mass and strength, potentially determining the insurgence of sarcopenia. Evidence suggests that motoneuron and neuromuscular junction (NMJ) degeneration contribute to sarcopenia pathogenesis. Seeking for strategies able to slow down sarcopenia insurgence and progression, we investigated whether a 2-year mixed-model training involving aerobic, strength and balance exercises would be effective for improving or preserving motoneuronal health and NMJ stability, together with muscle mass, strength and functionality in an old, sarcopenic population. METHODS Forty-five sarcopenic elderly (34 females; 11 males) with low dual-energy X-ray absorptiometry (DXA) lean mass and Short Physical Performance Battery (SPPB) score <9 were randomly assigned to either a control group [Healthy Aging Lifestyle Education (HALE), n = 21] or an intervention group [MultiComponent Intervention (MCI), n = 24]. MCI trained three times per week for 2 years with a mix of aerobic, strength and balance exercises matched with nutritional advice. Before and after the intervention, ultrasound scans of the vastus lateralis (VL), SPPB and a blood sample were obtained. VL architecture [pennation angle (PA) and fascicle length (Lf)] and cross-sectional area (CSA) were measured. As biomarkers of neuronal health and NMJ stability status, neurofilament light chain (NfL) and C-terminal agrin fragment (CAF) concentrations were measured in serum. Differences in ultrasound parameters, NfL and CAF concentration and physical performance between baseline and follow-up were tested with mixed ANOVA or Wilcoxon test. The relationship between changes in physical performance and NfL or CAF concentration was assessed through correlation analyses. RESULTS At follow-up, MCI showed preserved VL architecture (PA, Lf) despite a reduced CSA (-8.4%, P < 0.001), accompanied by maintained CAF concentration and ameliorated overall SPPB performance (P = 0.007). Conversely, HALE showed 12.7% decrease in muscle CSA (P < 0.001), together with 5.1% and 5.5% reduction in PA and Lf (P < 0.001 and P = 0.001, respectively), and a 6.2% increase in CAF (P = 0.009) but improved SPPB balance score (P = 0.007). NfL concentration did not change in either group. In the population, negative correlations between changes in CAF concentration and SPPB total score were found (P = 0.047), whereas no correlation between NfL and SPPB variations was observed. CONCLUSIONS The present findings suggest that our 2-year mixed aerobic, strength and balance training seemed effective for preventing the age and sarcopenia-related increases in CAF concentration, preserving NMJ stability as well as muscle structure (PA and Lf) and improving physical performance in sarcopenic older individuals.
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Alternate-Day Fasting Combined with Exercise: Effect on Sleep in Adults with Obesity and NAFLD.
Ezpeleta, M, Gabel, K, Cienfuegos, S, Kalam, F, Lin, S, Pavlou, V, Varady, KA
Nutrients. 2023;15(6)
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Non-alcoholic fatty liver disease (NAFLD) is defined as the presence of 5% or more fat in the liver, confirmed by hepatic imaging or biopsy. Poor sleep may adversely affect insulin sensitivity and inflammatory status, thereby contributing to the development and progression of NAFLD. The aim of this study was to investigate how intermittent fasting combined with exercise impacts body weight and sleep measures in adults with NAFLD. This study was a secondary analysis of a 3-month randomised, controlled, parallel-arm study. Participants were randomized to 1 of 4 intervention groups: alternate-day fasting (ADF) plus exercise, ADF alone, exercise alone, or a no-intervention control group. Results showed that intermittent fasting combined with exercise produced significant reductions in body weight and intrahepatic triglyceride content but no changes in sleep quality, duration, insomnia severity, or risk of obstructive sleep apnoea. Authors conclude that the weight loss induced by ADF combined with exercise does not improve sleep quality, duration, insomnia severity or risk of obstructive sleep apnea in individuals with obesity and NAFLD.
Abstract
Objective: This study investigated how alternate-day fasting (ADF) combined with aerobic exercise impacts body weight and sleep in adults with non-alcoholic fatty liver disease (NAFLD). Methods: Adults with obesity and NAFLD (n = 80) were randomized into one of four groups for 3 months: combination of ADF (600 kcal "fast day," alternated with an ad libitum intake "feast day") and moderate-intensity aerobic exercise (five sessions per week, 60 min/session); ADF alone; exercise alone; or a no-intervention control group. Results: By month 3, body weight and intrahepatic triglyceride content decreased (p < 0.001, group × time interaction) in the combination group versus the exercise group and control group, but not versus the ADF group. Sleep quality, measured by the Pittsburgh Sleep Quality Inventory (PSQI), did not change in the combination group (baseline: 6.0 ± 0.7; month 3: 5.6 ± 0.7), ADF group (baseline: 8.9 ± 1.0; month 3: 7.5 ± 0.8), or exercise group (baseline: 6.4 ± 0.6; month 3: 6.7 ± 0.6), versus controls (baseline: 5.5 ± 0.7; month 3: 4.6 ± 0.5). Wake time, bedtime, sleep duration, and insomnia severity did not change (no group x time interaction) over the course of the study in any group. Risk for obstructive sleep apnea was present in 30% of combination subjects, 75% of ADF subjects, 40% of exercise subjects, and 75% of controls, and did not change in the intervention groups, versus controls, by month 3. No associations were observed between changes in body weight, intrahepatic triglyceride content, and any sleep outcome. Conclusions: The weight loss induced by ADF combined with exercise does not improve sleep quality, duration, insomnia severity, or risk of obstructive sleep apnea in individuals with NAFLD.
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Insufficient sleep predicts poor weight loss maintenance after 1 year.
Bogh, AF, Jensen, SBK, Juhl, CR, Janus, C, Sandsdal, RM, Lundgren, JR, Noer, MH, Vu, NQ, Fiorenza, M, Stallknecht, BM, et al
Sleep. 2023;46(5)
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Short sleep duration, defined as less than 6 hours/night, is associated with all-cause mortality, cardiovascular diseases, hypertension, diabetes, and obesity. Sleep restriction causes metabolic and behavioural changes suggesting that short sleep duration may contribute to the development of obesity. The aim of this study was to investigate associations between short sleep duration or poor sleep quality and weight regain after weight loss. This study is based on data from the S-LiTE randomised, controlled trial. Participants followed a low-calorie diet (800 kcal/day) for eight weeks prior to randomisation. Those who lost at least 5% of initial weight were randomised to the control or intervention group. Results showed that participants with objectively measured short sleep duration after a diet-induced weight loss had less success during weight loss maintenance than those with longer sleep duration. Worse sleep quality was associated with less weight loss during a low-calorie diet and subsequent weight maintenance. Authors conclude that insufficient sleep predicts weight regain during interventional efforts to maintain weight loss. Exercise maintained low-calorie diet-induced improvements in sleep quality during 1 year of weight loss maintenance, and liraglutide transiently increased sleep duration.
Abstract
STUDY OBJECTIVES Insufficient sleep may attenuate weight loss, but the role of sleep in weight loss maintenance is unknown. Since weight regain after weight loss remains a major obstacle in obesity treatment, we investigated whether insufficient sleep predicts weight regain during weight loss maintenance. METHODS In a randomized, controlled, two-by-two factorial study, 195 adults with obesity completed an 8-week low-calorie diet and were randomly assigned to 1-year weight loss maintenance with or without exercise and liraglutide 3.0 mg/day or placebo. Sleep duration and quality were measured before and after the low-calorie diet and during weight maintenance using wrist-worn accelerometers (GENEActiv) and Pittsburgh Sleep Quality Index (PSQI). To test associations between insufficient sleep and weight regain, participants were stratified at randomization into subgroups according to sleep duration (≥6 h/night) or sleep quality (PSQI score ≤/>5). RESULTS After a diet-induced 13.1 kg weight loss, participants with short sleep duration at randomization regained 5.3 kg body weight (p = .0008) and had less reduction in body fat percentage compared with participants with normal sleep duration (p = .007) during the 1-year weight maintenance phase. Participants with poor sleep quality before the weight loss regained 3.5 kg body weight compared with good quality sleepers (p = .010). During the weight maintenance phase, participants undergoing liraglutide treatment displayed increased sleep duration compared with placebo after 26 weeks (5 vs. -15 min/night) but not after 1 year. Participants undergoing exercise treatment preserved the sleep quality improvements attained from the initial weight loss. CONCLUSIONS Short sleep duration or poor sleep quality was associated with weight regain after weight loss in adults with obesity.
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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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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.
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A Randomised Placebo-Controlled Study of Purified Anthocyanins on Cognition in Individuals at Increased Risk for Dementia.
Aarsland, D, Khalifa, K, Bergland, AK, Soennesyn, H, Oppedal, K, Holteng, LBA, Oesterhus, R, Nakling, A, Jarholm, JA, de Lucia, C, et al
The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry. 2023;31(2):141-151
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A growing body of evidence suggests that some modifiable factors, including cardiometabolic disorders such as hypertension, diabetes and hypercholesterolemia, as well as lifestyle factors such as physical exercise and diet, are associated with an increased risk of developing dementia. Anthocyanins, a flavonoid subclass found in dark berries and fruits, are among the dietary factors that may have positive effects on the pathogenesis of Alzheimer’s disease. The aim of this study was to assess whether anthocyanins can improve cognition and reduce the risk of dementia. This study is a 24-week randomised, double-blind, placebo-controlled Phase II study. Two-hundred and six participants were randomly assigned to one of the two groups: anthocyanins (n=106) or placebo (n=100). Results show that there wasn’t any significant group difference at the end of the study (24 weeks) in episodic memory (primary analysis) or for the secondary cognitive outcomes. However, there was a significant difference in slopes during weeks 8−24 where the anthocyanin group improved while the placebo group worsened. Furthermore, anthocyanin capsules were well-tolerated and safe to use. Authors conclude that future studies need to explore the potential mechanisms leading to cognitive improvement, how they relate to bioavailability of anthocyanins and metabolites, the optimal dosage, and the duration of treatment.
Abstract
IMPORTANCE Identifying nutritional compounds which can reduce cognitive decline in older people is a hugely important topic. OBJECTIVE To study the safety and effect of anthocyanins in maintaining cognitive functioning in people at increased risk for dementia. DESIGN, SETTING, AND PARTICIPANTS Participants (206 individuals, aged 60-80 years) diagnosed with either mild cognitive impairment (MCI) or two or more cardiometabolic disorders (i.e., diabetes, hypertension, obesity) were enrolled at three different centres in Norway. INTERVENTION Participants were randomly assigned to four capsules with a total of 320 mg/d of naturally purified anthocyanins or placebo 1:1 for 24 weeks. MAIN OUTCOMES AND MEASURES The primary outcome was the Quality of Episodic Memory composite measure (0-100) from an online cognitive test battery CogTrack, which was administered at baseline and monthly for the next 24 weeks. Secondary outcomes included other cognitive scores from the CogTrack battery. We applied mixed effects models with a baseline test score, group, time and their interaction as fixed effects, as well as other predefined baseline covariates. The primary comparison was the group difference at week 24 based on a modified intention-to-treat principle. RESULTS The primary analysis did not show a significant group difference at 24 weeks (78.2 versus 76.8; adjusted mean difference 1.4 (95% confidence interval -0.9-3.7); effect size 0.15; p = 0.23). However, there was a significant difference in slopes during weeks 8-24 (p = 0.007); the anthocyanin group improved while the placebo group worsened. No differences were found for the secondary cognitive outcomes. Anthocyanin capsules were well-tolerated and safe to use. CONCLUSION Anthocyanin supplementation for 24 weeks was safe and well tolerated in people with MCI or cardiometabolic disorders. We found no significant group difference in episodic memory at the end of the study but statistically significant differences in slopes. Further studies are warranted to explore whether anthocyanins supplementation can reduce cognitive decline in people at increased risk of dementia. TRIAL REGISTRATION ClinicalTrials.gov, (Identifier NCT03419039). http://www. CLINICALTRIALS gov/, NCT03419039.
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Does adding exercise or physical activity to pharmacological osteoporosis therapy in patients with increased fracture risk improve bone mineral density and lower fracture risk? A systematic review and meta-analysis.
Schumm, AK, Craige, EA, Arora, NK, Owen, PJ, Mundell, NL, Buehring, B, Maus, U, Belavy, DL
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2023;34(11):1867-1880
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Osteoporosis, a progressive systematic skeletal disease is caused by diminished bone density and strength, which may increase the risk of fragility fractures in the spine, pelvis, femur etc. Women are at greater risk of developing osteoporosis. Osteopenia is an intermediary stage of reduced bone mineral density before progressing into the osteoporosis disease state. Exercise and pharmacological therapies are considered two effective strategies commonly used in the treatment of osteoporosis. Exercise may help to improve bone mineral density, strength and muscle mass and reduce the risk of fractures. This systematic review and meta-analysis of five parallel-arm randomised controlled trials investigated the combined effect of exercise and pharmacological therapy on bone mineral density, bone turnover markers, fractures and fracture healing in patients with osteopenia and osteoporosis. This systematic review and meta-analysis showed a non-significant improvement in bone mineral density in patients with osteopenia and osteoporosis followed by combined pharmacological treatment with exercise. Pharmacological therapy alone showed improvement and maintenance of bone mineral density. There was no evidence for the improvement in fragility fracture healing. Due to the low evidence and high heterogeneity of included studies, further robust studies are required to evaluate the combined effect of exercise and pharmacological therapy in people with systematic skeletal disease. Healthcare professionals can use this study to understand the benefits of pharmacological therapy in improving osteoporosis and osteopenia and the potential of adding exercise as a therapeutic strategy in clinical practice.
Abstract
This prospectively registered systematic review and meta-analysis examines whether exercise (EX) training has an additive effect to osteoanabolic and/or antiresorptive pharmacological therapy (PT) in people with osteoporosis on bone mineral density (BMD), bone turnover markers (BTMs), fracture healing, and fractures. Four databases (inception to 6 May 2022), 5 trial registries, and reference lists were searched. Included were randomized controlled trials comparing the effect of EX + PT vs. PT with regard to BMD, BTM, fracture healing, and fractures. Risk of bias was assessed using the Cochrane RoB2 and certainty of evidence by the GRADE approach. Random-effects meta-analysis with Hartung-Knapp-Sidik-Jonkman adjustment was used to estimate standardized mean differences and 95% confidence intervals. Out of 2593 records, five RCTs with 530 participants were included. Meta-analysis showed with very low certainty evidence and wide confidence intervals that EX + PT compared to PT had larger effect sizes for BMD at 12 months at the hip (SMD [95%CI]: 0.18 [- 1.71; 2.06], n = 3 studies), tibia (0.25 [- 4.85; 5.34], n = 2), lumbar spine (0.20 [- 1.15; 1.55], n = 4), and forearm (0.05 [- 0.35; 0.46], n = 3), but not femoral neck (- 0.03 [- 1.80; 1.75], n = 3). Furthermore, no improvement was revealed for BTM such as bone ALP (- 0.68 [- 5.88; 4.53], n = 3), PINP (- 0.74 [- 10.42; 8.93], n = 2), and CTX-I (- 0.69 [- 9.61; 8.23], n = 2), but with very wide confidence intervals. Three potentially relevant ongoing trials were identified via registries. No data were found for fracture healing or fracture outcomes. It remains unclear whether EX has an additive impact to PT in people with osteoporosis. High-quality, adequately powered, targetted RCTs are required. PROTOCOL REGISTRATION PROSPERO CRD42022336132.
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Neck-specific strengthening exercise compared with placebo sham ultrasound in patients with migraine: a randomized controlled trial.
Benatto, MT, Florencio, LL, Bragatto, MM, Dach, F, Fernández-de-Las-Peñas, C, Bevilaqua-Grossi, D
BMC neurology. 2022;22(1):126
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Patients with migraine may experience neck pain, worsened performance of cervical muscles, reduced cervical spine range of motion, and increased muscle sensitivity in the craniocervical region. Physiotherapy is an important nonpharmacological treatment option for reducing the duration and frequency of migraine attacks and may include manual therapy, soft-tissue techniques, and strength and endurance training. The aim of this study was to verify the effectiveness of craniocervical muscle-strengthening exercise (CMSE) in reducing the frequency and intensity of headache in migraine patients. This study is a two-armed, parallel-group randomized controlled trial. Men and women aged between 18 and 55 years, diagnosed only with migraine and at least three days of pain per month were included. Participants were randomly assigned to one of the two groups; intervention (n=21) or placebo (n=21) group. Results show that CMSE neither reduced the frequency and intensity of headache nor improved the performance and sensitivity of the cervical muscles, cervical range of motion, and migraine and neck pain-related disabilities. However, a significant improvement for pressure pain threshold was noticed in the sensitivity of the frontal muscle in favour of the intervention group. Authors conclude that performing CMSE is not enough to reduce the frequency and intensity of headache or improve the performance of the cervical muscles and reduce migraine and neck pain related disabilities.
Abstract
BACKGROUND Migraine patients have musculoskeletal disorders and pain in the cervical. And, despite the pathophysiology demonstrating the relationship between migraine and the cervical spine, the effectiveness of craniocervical exercises in these patients has not been verified. So, the aimed of this study was verify the effectiveness of craniocervical muscle-strengthening exercise (CMSE) in reducing the frequency and intensity of headache in migraine patients. METHODS A two-armed, parallel-group randomized controlled trial with a 3-month follow-up was performed. For eight weeks, the volunteers in the intervention group (n = 21) performed a protocol of CMSE, while those in the sham ultrasound group (n = 21) received the application of disconnected therapeutic ultrasound in the upper trapezius and guideline for home-stretching. The primary outcomes were the frequency and intensity of the headache. The secondary outcomes were questionnaires about migraine and neck disability, and satisfaction with the treatment, cervical range of motion, the pressure pain threshold, craniocervical flexion test (CCFT), cervical muscle strength and endurance test, and the cervical muscle activity during the physical tests. RESULTS No differences were observed for the changes observed in primary outcomes after eight weeks and at the 3-months follow up (p > 0.05). For the secondary outcomes, craniocervical exercises improved the sensitivity of the frontal muscle (p = 0.040) and promoted a reduced amplitude of muscle activity of the anterior scalene and upper trapezius in the last stages of CCFT (p ≤ 0.010). There was also reduced muscle activity of the anterior scalene and splenius capitis in the endurance test (p ≤ 0.045), as evaluated by surface electromyography. CONCLUSION CMSE were insufficient in reducing the frequency and intensity of headache, improving the performance of the cervical muscles, or reducing migraine and neck pain-related disabilities. This was found despite a decreased electromyographic activity of the cervical muscles during the last stages of CCFT and increased median frequency during the endurance test. TRIAL REGISTRATION Accession code RBR-8gfv5j , registered 28/11/2016 in the Registro Brasileiro de Ensaios Clínicos (ReBEC).