MiOA: Intervention: Community: Oral Nutrition Supplements (2023)

Author and Year:
Roshel H, Hayashi A, Fernandes A, et al. 2020
PubMed ID:
Article Title:
Supplement-based nutritional strategies to tackle frailty: A multifactorial, double-blind, randomized placebo-controlled trial.
Roschel H, Hayashi A, Fernandes A, Jambassi-Filho J, Hevia-Larraín V, de Capitani M, Santana D, Gonçalves L, de Sá-Pinto A, Lima F, Sapienza M, Duarte A, Pereira R, Phillips S, Gualano B
Clinical Nutrition (Edinburgh, Scotland)
Year of publication:
Page numbers:
Study Design:
Randomized Controlled Trial
Risk of Bias Assessment Rating:
Low risk
Inclusion Criteria:
Age over 65 years, classified as frail or pre-frail according to Fried's criteria (based on unintentional weight loss, weakness, self-reported exhaustion, slow walking speed, and low physical activity)
Exclusion Criteria:
Use of insulin or steroid-based drugs; use of protein- or amine-based supplements; under a caloric or food-group dietary restriction; currently engaged in resistance training; untreated chronic disease; any musculoskeletal condition precluding exercise
Research Purpose:
Researchers were testing the efficacy of leucine, whey protein, soy protein, creatine, and creatine plus whey versus placebo-matched controls. They hypothesized that leucine, protein supplementation, creatine, and creatine plus whey, would augment the effects of resistance exercise with respect to strength and muscle mass.
Blinding efforts:
A nutritionist blinded to the study delivered the supplements (or placebo), explained how to take them, and was available to answer any questions. Supplements and placebo were delivered in black plastic containers with a standardized measuring scoop. At the end of the follow-up, participants were surveyed about which supplement they believed to have taken. The percentage of correct answers was compared between groups to test the effectiveness of the blinding.
Study Location:
University of Sao Paulo, School of Medicine (Sao Paulo, Brazil)
Source(s) of Funding:
Government, Not-for-profit
Please specify names of funders:
The National Council of Scientific and Technological Development (CNPq), CAPES (program of the Ministry of Education in Brazil), and FAPESP (The São Paulo Research Foundation - public institution supporting research in higher education and research institutions)