MiOA: Intervention: Long-Term Care: Oral Nutrition Supplements (2023)
Author and Year:
Rondanelli M, Klersy C, Terracol G, et al. 2016
PubMed ID:
Article Title:
Whey protein, amino acids, and vitamin D supplementation with physical activity increases fat-free mass and strength, functionality, and quality of life and decreases inflammation in sarcopenic elderly.
Authors:
Rondanelli M, Klersy C, Terracol G, Talluri J, Maugeri R, Guido D, Faliva M, Solerte B, Fioravanti M, Lukaski H, Perna S
Journal:
The American Journal of Clinical Nutrition
Year of publication:
2016
Volume:
103
Issue:
3
Page numbers:
830-840
Study Design:
Randomized Controlled Trial
Risk of Bias Assessment Rating:
Low risk
Inclusion Criteria:
65 y or older; appendicular skeletal FFM divided by height squared 2 SD below the mean for young adults (relative muscle mass 7.26 kg/m2 for men and 5.5 kg/m2 for women); similar physical ability, assessed with the activities of daily living (ADL) score, and normal cognitive function or only mild cognitive disturbance as defined by aMini-Mental State Examination.20.
Exclusion Criteria:
Evidence of heart disease, kidney or liver disease, or any other disease that might influence the results of the study; acute illness or severe liver, heart, or kidney dysfunction; significant body weight change in the past 6 months; altered glyco-metabolic control, thyroid disorders, other endocrinopathies, or cancers, and any patients treated with steroids and heparin; total walking incapacity
Research Purpose:
We designed a randomized, double-blind, placebo-controlled supplementation trial that combined whey protein, essential amino acids, and vitamin D with regular physical activity for all participants. We set out to test whether, compared with placebo, supplementation would increase fat-free mass (FFM) while improving strength, nutritional status, inflammation, and measures of quality of life and physical function (secondary outcomes).
Blinding efforts:
Participants were assigned to a treatment according to a coded (AB) block randomization table prepared by an independent statistician. Investigators were blinded to the randomization table, the code assignments, and the procedure. As people were enrolled they were assigned a progressive number. A research dietitian, blinded to the randomization schedule provided by the statistician, distributed the supplements to participants each day.
Study Location:
Santa Margherita Hospital, Pavia, Italy
Source(s) of Funding:
Government
Please specify names of funders:
Italian Ministry of the University and Research to the University of Pavia Department of Public Health