Nutritional supplementation with physical activity improves muscle composition in mobility‐limited older adults, the VIVE2 study: a randomized, double‐blind, placebo‐controlled trial
Authors: Englund Davis , Kirn Dylan , Koochek Afsaneh , Travison Thomas , Reid Kieran , von Berens Åsa , Zhu Hao , Lilja Mats , Gustafsson Thomas , Cederholm Tommy , Fielding Roger 
Published: June 2021

BackgroundNutritional supplementation and structured physical activity have been shown to positively influence muscle mass and strength in older adults. The efficacy of long‐term nutritional supplementation in combination with structured physical activity in this population remains unclear.ObjectiveTo examine the effects of a combined intervention of nutritional supplementation and structured physical activity compared to a placebo, on measures of total‐body and thigh composition and knee extensor strength in a cohort of mobility‐limited older adults across two sites (Boston, MA, USA and Stockholm, Sweden).DesignMobility‐limited (Short Physical Performance Battery (SPPB) ≤9) and vitamin D insufficient (serum 25(OH) D 9 – 24 ng/ml) older adults were recruited for this study. All subjects participated in a physical activity program (3x/week for 24 weeks), involving walking, strength, balance, and flexibility exercises. Subjects were randomized consume a daily nutritional supplement (150kcal, 20g whey protein, 800IU vitamin D, 4 fl. oz. beverage) or placebo (30kcal, non‐nutritive). We examined total‐body composition (DXA), thigh composition (CT), and muscle strength, power, and quality before and after the 6‐month intervention.Results149 subjects were randomized into the study (mean age=77.5±5.4; female=46.3%; mean SPPB= 7.9±1.2; mean vitamin D=18.7±6.4 ng/ml). Adherence across supplement and placebo groups was similar for the physical activity intervention (75% and 72%, respectively) and the study product (86% and 88%, respectively). After the intervention period both groups demonstrated improvements in total‐body composition, subcutaneous fat, intermuscular fat, and strength measures. Nutritional supplementation lead to further losses of intermuscular fat (treatment effect: −0.33 cm2, 95% CI: −0.68 ~ 0.02), increased normal density muscle (treatment effect: 3.17 cm2, 95% CI: 0.52 ~ 5.83), and an increase in serum 25(OH)D (treatment effect: 4.55 ng/ml, 95% CI: 2.03 ~ 7.08).ConclusionsSix‐months of structured physical activity resulted in improvements in body composition, subcutaneous fat, intermuscular fat, and strength measures. The addition of nutritional supplementation resulted in a greater decline in intermuscular fat and improved muscle density. These results suggest nutritional supplementation provides additional benefits in mobility‐limited and vitamin D deficient older adults.Support or Funding InformationThis study was supported in part by Nestle' Health Science. In addition, this work was also supported by the U.S. Department of Agriculture (USDA), under agreement No. 58‐1950‐0‐014 and the Boston Claude D. Pepper Center Older American Independence Centers (OAIC; 1P30AG031679). Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the USDA.