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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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BackgroundInfluentialGender-Specific Impact of Sex Hormones on the Immune System
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Rogeri, P. S., Zanella, R., Martins, G. L., Garcia, M. D. A., Leite, G., Lugaresi, R., Gasparini, S. O., Sperandio, G. A., Ferreira, L. H. B., Souza-Junior, T. P., et al. (2021) · Nutrients · doi:10.3390/nu14010052 · Cited by 181
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“However, recent studies examining increased protein intake in older individuals do not show increased lean body mass (LBM) accretion (Bhasin et al., 2018), and that the amount and quality of protein intake are not associated with muscle mass or strength in older adults (Gingrich et al.”
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“Increasing protein content in an iso-caloric diet has been shown to result in the loss of fat mass (18), but in the present study supplementation of any kind was associated with an increase in the fat percentage, with no marked change in LTM or body weight.”
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Phillips, S. M., Paddon-Jones, D., & Layman, D. K. (2020) · Advances in Nutrition · doi:10.1093/advances/nmaa047 · Cited by 65
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Is It Time to Reconsider the U.S. Recommendations for Dietary Protein and Amino Acid Intake?
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“[12] demonstrated a beneficial effect of protein on physical performance in frail elderly adults but others did not demonstrate any long-term benefit [49].”
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Madhu, S., Kapoor, N., Das, S., Nishant, R., & Sanjay, K. (2022) · Indian Journal of Endocrinology and Metabolism · doi:10.4103/2230-8210.356236 · Cited by 47
“8 g/kg per day protein is enough to maintain lean body mass and muscle function.[119,120] At present, there is inadequate data to support the use of pharmacotherapy and bariatric surgery in sarcopenic obesity.”
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“Protein intake as it relates to aging adults and skeletal muscle quantity and performance is particularly important (45, 53), but the varied experimental designs in the 5 articles resulted in 4 iterations of energy balance and RT, which precluded aggregating the articles separately.”
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“Likewise, whether this association with protein-rich food applied to a frail older adults was still unclear [35].”
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“Only 4 of the 16 trials reported greater fat mass losses in high- compared with low-protein groups (24, 57, 71, 76); 3 trials reported higher or maintained lean or fat-free masses in high- v.”
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“However, protein’s effects on lean body mass and physical performance diminish with age.(38) The protein recommended daily allowance is based on nitrogen balance studies, an inadequate outcome for older adults at risk of sarcopenia.”
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“However, a significant reduction in intramuscular fat and increase in normal density muscle was observed with the nutritional supplement (29, 30).”
Protein-Restricted Diets and Their Impact on Metabolic Health and Aging
Kim, S. Q., Spann, R. A., Hill, C. M., Berryman, C. E., Berthoud, H., McDougal, D. H., He, Y., Münzberg, H., Yu, S., & Morrison, C. D. (2025) · Annual Review of Nutrition · doi:10.1146/annurev-nutr-121624-114918 · Cited by 17
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“Besides, various studies that have been conducted to determine protein intake effectiveness in the elderly population are biased, since they were performed recruiting healthy older adults without functional limitations and not individuals with protein intakes lower than the recommended daily dose [20].”
BackgroundThe medicalization of testosterone: reinventing the elixir of life
Gagliano‐Jucá, T., Álvarez, M., & Basaria, S. S. (2022) · Reviews in Endocrine and Metabolic Disorders · doi:10.1007/s11154-022-09751-8 · Cited by 16
Self-citationAndrogens as the “old age stick” in skeletal muscle
Gentile, G., Stefano, F. D., Sorrentino, C., D’Angiolo, R., Lauretta, C., Giovannelli, P., Migliaccio, A., Castoria, G., & Donato, M. D. (2025) · Cell Communication and Signaling · doi:10.1186/s12964-025-02163-6 · Cited by 18
“…trials have consistently reported a significant improvement of the 6-minutes walking distance test, stair climb power, leg press strength and power on androgen treat-ment, once again indicating a dangerous liaison between the androgen decline and the loss of skeletal muscle tro-phism [127, 140].”
Optimizing Diagnostic Accuracy and Treatment Decisions in Men With Testosterone Deficiency
Bhasin, S., & Ozimek, N. (2021) · Endocrine Practice · doi:10.1016/j.eprac.2021.08.002 · Cited by 15
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“The adherence with dietary prescription (81%–86%) and testosterone/placebo injections (>99%) was high (14).”
BackgroundInfluentialSelf-citationFigueiredo, M. G., Gagliano‐Jucá, T., & Basaria, S. S. (2023) · Endocrinology and Metabolism Clinics of North America · doi:10.1016/j.ecl.2022.12.002 · Cited by 12
Self-citationNutritional approaches targeting mitochondria for the prevention of sarcopenia
Hahm, J., Nirmala, F. S., Ha, T. Y., & Ahn, J. (2023) · Nutrition Reviews · doi:10.1093/nutrit/nuad084 · Cited by 13
Reinders, I., Visser, M., & Wijnhoven, H. A. H. (2020) · Clinical Nutrition ESPEN · doi:10.1016/j.clnesp.2020.02.020 · Cited by 12
Norouzi, M., Nadjarzadeh, A., Maleki, M., Khayyatzadeh, S. S., Hosseini, S., Yaseri, M., & Fattahi, H. (2022) · BMC Surgery · doi:10.1186/s12893-022-01495-1 · Cited by 12
“Also, the amount and type of protein intake has been studied [13]; although some studies indicated that taking protein from diet or supplements is associated with the prevention of excessive inflammatory responses [18, 19], some others reported conflicting results [20, 21].”
ResultSilva, T. R., Lago, S. C., Yavorivski, A., Ferreira, L. L., Fighera, T. M., & Spritzer, P. M. (2020) · Menopause The Journal of The North American Menopause Society · doi:10.1097/gme.0000000000001692 · Cited by 11
“As an integrated marker of protein anabolism, LBM can be measured precisely and is responsive to dietary interventions.(29) Secondary outcomes included appendicular lean mass (ALM), whole body and trunk fat mass and visceral adipose tissue (VAT).”
BackgroundStrasser, B., Grote, V., Bily, W., Nics, H., Riedl, P., Jira, I., & Fischer, M. J. (2023) · Healthcare · doi:10.3390/healthcare11162317 · Cited by 10
“5 g/kg per day may be too low for functionally limited older patients to successfully recover muscular strength and physical function, especially those with chronic diseases [26].”
BackgroundOgawa, M., Yoshida, N., Satomi‐Kobayashi, S., Tsuboi, Y., Komaki, K., Wakida, K., Gotake, Y., Inoue, T., Tanaka, H., Yamashita, T., et al. (2019) · Journal of Cardiology · doi:10.1016/j.jjcc.2019.03.011 · Cited by 10
O’Leary, F., Grech, A. L., Sui, Z., Cheng, H., Rangan, A., & Hirani, V. (2019) · European Journal of Clinical Nutrition · doi:10.1038/s41430-019-0478-x · Cited by 10
“There is some evidence that there may be benefits of higher protein intakes in protecting against the development of age-related syndromes including sarcopenia and frailty [15, 36–38]; however the evidence is mixed [39].”
BackgroundCheese: mere indulgence or part of a healthy diet?
Eugénio, A. T., Ramos, R., Barreto, I. R., Carriço, R., Marcos, J., Camelo, A., Santo, C. E., & Brandão, I. (2025) · Frontiers in Nutrition · doi:10.3389/fnut.2025.1649432 · Cited by 9
Khanal, P., He, L., Degens, H., Stebbings, G. K., Onambélé-Pearson, G. L., Williams, A. G., Thomis, M. A., & Morse, C. I. (2021) · Nutrients · doi:10.3390/nu13093076 · Cited by 12
“Investigating the beneficial effect of protein and other nutrients on muscle phenotypes has utilized several approaches previously, with some studies identifying direct associations between nutrients and muscle phenotypes while some identified nutrients profiles of healthy elderly individuals [28–31].”
BackgroundIs Exercise Beneficial and Safe in Patients with Cirrhosis and Portal Hypertension?
Tapper, E. B., Martínez-Macías, R. F., & Duarte‐Rojo, A. (2018) · Current Hepatology Reports · doi:10.1007/s11901-018-0404-z · Cited by 9
Network pharmacology-based analysis of the effects of puerarin on sarcopenia
Chen, X., Wang, Y., Liu, M., Song, X., Wang, D., & Zhang, J. (2022) · Annals of Translational Medicine · doi:10.21037/atm-22-2360 · Cited by 7
“For some patients, exercise therapy is limited by advanced age and disease conditions, while evidence of the effectiveness of nutritional interventions alone has not yet been gathered by highquality studies (8,20).”
BackgroundThe anabolic applications of androgens in older adults with functional limitations
Gattu, A. K., Goldman, A. L., Guzelce, E. C., Galbiati, F., & Bhasin, S. (2022) · Reviews in Endocrine and Metabolic Disorders · doi:10.1007/s11154-022-09766-1 · Cited by 9
Self-citationCorrea‐de‐Araujo, R., & Bhasin, S. (2022) · The Journals of Gerontology Series A · doi:10.1093/gerona/glac181 · Cited by 7
Self-citationFraile‐Μartinez, O., Ortega, M. A., & Montero, C. G. (2026) · International Journal of Molecular Sciences · doi:10.3390/ijms27020692 · Cited by 12
Niskanen, R. T., Reinders, I., Wijnhoven, H. A. H., Hyvönen, A., Pols‐Vrijmoeth, M., Trommel‐Bout, M., Visser, M., Pitkälä, K. H., Suominen, M. H., Öhman, H., et al. (2023) · Journal of Human Nutrition and Dietetics · doi:10.1111/jhn.13197 · Cited by 7
Overdevest, E., Dorhout, B. G., Nicolaou, M., van Valkengoed, I. G. M., Haveman‐Nies, A., Oztürk, H., de Groot, C. P. G. M., Tieland, M., & Weijs, P. J. M. (2021) · Nutrients · doi:10.3390/nu13010184 · Cited by 7
Molecular cloning, characterization, and functional analysis of the uncharacterized C11orf96 gene
Yang, H., Zhu, J., Guo, H., Tang, A., Chen, S., Zhang, D., Yuan, L., & Liu, G. (2022) · BMC Veterinary Research · doi:10.1186/s12917-022-03224-5 · Cited by 7
Sarcopenia in Aging: Pathogenesis, Diagnosis, and Emerging Therapeutic Frontiers
Jeyaraman, M., Jeyaraman, N., Nallakumarasamy, A., Ramasubramanian, S., Muthu, S., Murugan, S., Rajendran, S. N. S., Rajendran, R. L., Ahn, B., & Gangadaran, P. (2025) · Molecular Imaging and Biology · doi:10.1007/s11307-025-02071-8 · Cited by 7
Pharmacological targeting of age-related changes in skeletal muscle tissue
Leuchtmann, A. B., & Handschin, C. (2019) · Pharmacological Research · doi:10.1016/j.phrs.2019.02.030 · Cited by 7
Optimizing the Design of Clinical Trials to Evaluate the Efficacy of Function-Promoting Therapies
Bhasin, S., Cawthon, P. M., Correa‐de‐Araujo, R., Storer, T. W., Volpi, E., Newman, A. B., Dioh, W., Tourette, C., Evans, W. J., & Fielding, R. A. (2023) · The Journals of Gerontology Series A · doi:10.1093/gerona/glad024 · Cited by 6
Self-citationIgarashi, H., Uchino, H., Kanaguchi, M., Hisanaga, K., Sato, G., Yoshikawa, F., Furuta, M., Washizawa, N., Usui, S., Miyagi, M., et al. (2023) · Diabetology & Metabolic Syndrome · doi:10.1186/s13098-023-00990-6 · Cited by 5
“Increased total body muscle mass and higher total daily dose of insulin within the CRIC group, implicating increased anabolic demands due to the relatively high proportion of the protein intake [22, 23] Data from series of studies suggest that high protein intake could have detrimental metabolic effects; acute intrave…”
BackgroundApovian, C., Singer, M., Campbell, W. W., Bhasin, S., McCarthy, A. C., Shah, M. S., Basaria, S., & Moore, L. (2017) · The Journal of Nutrition, Health & Aging · doi:10.1007/s12603-017-0990-4 · Cited by 5
Self-citationWu, X., Lim, K. J., Ma, Y., Gu, J., Jiang, Y., Zhu, L., Chen, Y., & Sun, J. (2026) · Journal of Cachexia Sarcopenia and Muscle · doi:10.1002/jcsm.70212 · Cited by 4
“However, another intervention trial done in nonsarcopenic patients with reduced mobility comparing the effects of normal versus increased protein intake on mobility showed no differences between these interventions [12].”
Kramer, C. S., Monsegue, A. P., Morwani‐Mangnani, J., Grootswagers, P., Beekman, M., Slagboom, P. E., Verdijk, L. B., & de Groot, C. P. G. M. (2024) · Mechanisms of Ageing and Development · doi:10.1016/j.mad.2024.112002 · Cited by 5
“Muscle mass, as measured by ALM, is estimated to require n = 25 in the mobility compromised group (Beaudart et al., 2020), n = 24 in the metabolically compromised group (Bhasin et al., 2018; Tieland et al., 2012b), and n = 55 in the TKR group (Liao et al., 2020).”
Dietary protein and muscle wasting in chronic kidney disease: new insights
Güngör, Ö., Kara, A. V., Hasbal, N. B., & Kalantar‐Zadeh, K. (2023) · Current Opinion in Clinical Nutrition & Metabolic Care · doi:10.1097/mco.0000000000000903 · Cited by 5
“[31] conducted a randomized controlled trial in elderly patients with physical function limitations.”
BackgroundNutritional requirements during ageing
Lecerf, J. (2019) · Object Constraint Language · doi:10.1051/ocl/2019015 · Cited by 3
Akazawa, N., Funai, K., Hino, T., Tsuji, R., Tamura, W., Tamura, K., Hioka, A., & Moriyama, H. (2023) · Clinical Nutrition ESPEN · doi:10.1016/j.clnesp.2023.09.922 · Cited by 2
Nagy, S.-R., Mititelu, M., Marin, R. C., Popovici, V., Pallag, A., & Jurca, T. (2025) · Sports · doi:10.3390/sports13060182 · Cited by 3
“Numerous studies investigated protein and amino acid supplementation associated with RT benefits in older people [12,18,20,23,61,74,81,84,101–111] Gender-related differences were evident in all exercises, with men consistently out-performing women.”
InfluentialBesoins nutritionnels au cours du vieillissement
Lecerf, J. (2019) · Cahiers de Nutrition et de Diététique · doi:10.1016/j.cnd.2019.06.002 · Cited by 2
Nagy, S.-R., Mititelu, M., Popovici, V., Marin, R.-C., Pallag, A., & Jurca, T. (2025) · Journal of Functional Morphology and Kinesiology · doi:10.3390/jfmk10030248 · Cited by 2
Differing dietary patterns according to body composition
Lee, Y.-C., Kim, H.-M., Lee, H. S., Jeon, S., Kwon, Y., & Lee, J. (2025) · Frontiers in Nutrition · doi:10.3389/fnut.2025.1509620 · Cited by 1
High-Protein Diets: What to Tell Our Patients
Garibotto, G., Verzola, D., Picciotto, D., & Russo, E. (2026) · American Journal of Kidney Diseases · doi:10.1053/j.ajkd.2026.01.023 · Cited by 1
Highlights from the 2019 International Congress on Frailty and Sarcopenia Research
Maltais, M. L., Aubertin‐Leheudre, M., Dray, C., Fielding, R. A., Rolland, Y., Cesari, M., & Vellas, B. J. (2019) · The Journal of Frailty & Aging · doi:10.14283/jfa.2019.13 · Cited by 1
“Dr Shalender Bashin presented preliminary results showing that protein intake higher than the recommended daily allowance (RDA) may not be always needed for improving muscle mass and function in older adults (24).”
Rooks, D. (2019) · Current Physical Medicine and Rehabilitation Reports · doi:10.1007/s40141-019-00236-5 · Cited by 1
Function Promoting Therapies Come of Age
Fielding, R. A. (2019) · The Journals of Gerontology Series A · doi:10.1093/gerona/glz171
“3 g/kg/d for 6 months did not further increase lean body mass over and above the increases observed with testosterone therapy alone (14).”
Background
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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