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Effect of Protein Intake on Lean Body Mass in Functionally Limited Older Men: A Randomized Clinical Trial
Open accessAbstract
Importance: The Institute of Medicine set the recommended dietary allowance (RDA) for protein at 0.8 g/kg/d for the entire adult population. It remains controversial whether protein intake greater than the RDA is needed to maintain protein anabolism in older adults. Objective: To investigate whether increasing protein intake to 1.3 g/kg/d in older adults with physical function limitations and usual protein intake within the RDA improves lean body mass (LBM), muscle performance, physical function, fatigue, and well-being and augments LBM response to a muscle anabolic drug. Design, Setting, and Participants: This randomized clinical trial with a 2 × 2 factorial design was conducted in a research center. A modified intent-to-treat analytic strategy was used. Participants were 92 functionally limited men 65 years or older with usual protein intake less thanor equal to 0.83 g/kg/d within the RDA. The first participant was randomized on September 21, 2011, and the last participant completed the study on January 19, 2017. Interventions: Participants were randomized for 6 months to controlled diets with 0.8 g/kg/d of protein plus placebo, 1.3 g/kg/d of protein plus placebo, 0.8 g/kg/d of protein plus testosterone enanthate (100 mg weekly), or 1.3 g/kg/d of protein plus testosterone. Prespecified energy and protein contents were provided through custom-prepared meals and supplements. Main Outcomes and Measures: The primary outcome was change in LBM. Secondary outcomes were muscle strength, power, physical function, health-related quality of life, fatigue, affect balance, and well-being. Results: Among 92 men (mean [SD] age, 73.0 [5.8] years), the 4 study groups did not differ in baseline characteristics. Changes from baseline in LBM (0.31 kg; 95% CI, -0.46 to 1.08 kg; P = .43) and appendicular (0.04 kg; 95% CI, -0.48 to 0.55 kg; P = .89) and trunk (0.24 kg; 95% CI, -0.17 to 0.66 kg; P = .24) lean mass, as well as muscle strength and power, walking speed and stair-climbing power, health-related quality of life, fatigue, and well-being, did not differ between men assigned to 0.8 vs 1.3 g/kg/d of protein regardless of whether they received testosterone or placebo. Fat mass decreased in participants given higher protein but did not change in those given the RDA: between-group differences were significant (difference, -1.12 kg; 95% CI, -2.04 to -0.21; P = .02). Conclusions and Relevance: Protein intake exceeding the RDA did not increase LBM, muscle performance, physical function, or well-being measures or augment anabolic response to testosterone in older men with physical function limitations whose usual protein intakes were within the RDA. The RDA for protein is sufficient to maintain LBM, and protein intake exceeding the RDA does not promote LBM accretion or augment anabolic response to testosterone. Trial Registration: clinicaltrials.gov Identifier: NCT01275365.
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“higher doses have recently demonstrated no changes in lean mass273”
From Sarcopenic obesity in older adults: aetiology, epidemiology and treatment strategies (2018) · cites this paper as [273]
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“…studies, we excluded nine studies (Norton et al. 2016; Kim et al. 2021; Johnson et al. 2021; Mori et al. 2023; Park et al. 2023; Zeng et al. 2019; Bhasin et al. 2018; ClinicalTrials.gov 2022, 2018) due to assessment of study de-sign, wrong comparator or interventions, outcomes, and ongoing…”
Metadata
- Authors
- Bhasin, S., Apovian, C. M., Travison, T. G., Pencina, K., Moore, L. L., Huang, G., Campbell, W. W., Li, Z., Howland, A. S., Chen, R., Knapp, P. E., Singer, M. R., Shah, M., Secinaro, K., Eder, R. V., Hally, K., Schram, H., Bearup, R., Beleva, Y. M., McCarthy, A. C., Woodbury, E., McKinnon, J., Fleck, G., Storer, T. W., & Basaria, S.
- Affiliations
- Brigham and Women's Hospital (US)
- Boston Medical Center (US)
- Beth Israel Deaconess Medical Center (US)
- Boston University (US)
- Purdue University West Lafayette (US)
- Corresponding author
- Bhasin, Shalender
- ORCID
- Venue
- JAMA Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2018-04-01
- Volume
- 178
- Issue
- 4
- Pages
- 530
- ISSN
- 2168-6106 (ISSN-L)
- PMC
- PMC5885156
- OpenAlex
- W2790541301
- Cited by
- 113
- References
- 51
- Citations by year
- 2026: 6 · 2025: 9 · 2024: 2 · 2023: 14 · 2022: 21 · 2021: 14 · 2020: 17 · 2019: 19 · 2018: 9
- FWCI
- 10.14
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Internal Medicine (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Heart, Lung, and Blood Institute (K08HL132122)
- Topics
- Health Sciences › Medicine › Physiology (medical) › Nutrition and Health in Aging
- Health Sciences › Nursing › Nutrition and Dietetics › Muscle metabolism and nutrition
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Muscle Physiology and Disorders
- Keywords
- protein intake, lean body mass, older men, functional limitations, high-protein diet, testosterone enanthate, muscle strength, muscle power, physical function, health-related quality of life, fatigue, well-being, sarcopenia, appendicular lean mass, walking speed, balance, protein supplementation
- MeSH terms
- Activities of Daily Living, Affect, Aged, Aged, 80 and over, Androgens, Body Composition, Dietary Proteins, Double-Blind Method, Fatigue, Health Status, Humans, Male, Mental Health, Quality of Life, Testosterone, Absorptiometry, Photon, Muscle Strength, Independent Living, Recommended Dietary Allowances
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