A 2-year randomized controlled trial of human caloric restriction: Feasibility and effects on predictors of health span and longevity
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BACKGROUND: Caloric restriction (CR), energy intake reduced below ad libitum (AL) intake, increases life span in many species. The implications for humans can be clarified by randomized controlled trials of CR. METHODS: To determine CR's feasibility, safety, and effects on predictors of longevity, disease risk factors, and quality of life in nonobese humans aged 21-51 years, 218 persons were randomized to a 2-year intervention designed to achieve 25% CR or to AL diet. Outcomes were change from baseline resting metabolic rate adjusted for weight change ("RMR residual") and core temperature (primary); plasma triiodothyronine (T3) and tumor necrosis factor-α (secondary); and exploratory physiological and psychological measures. RESULTS: Body mass index averaged 25.1 (range: 21.9-28.0 kg/m(2)). Eighty-two percent of CR and 95% of AL participants completed the protocol. The CR group achieved 11.7±0.7 %CR (mean ± standard error) and maintained 10.4±0.4% weight loss. Weight change in AL was negligible. RMR residual decreased significantly more in CR than AL at 12 months (p = .04) but not 24 months (M24). Core temperature change differed little between groups. T3 decreased more in CR at M12 and M24 (p < .001), while tumor necrosis factor-α decreased significantly more only at M24 (p = .02). CR had larger decreases in cardiometabolic risk factors and in daily energy expenditure adjusted for weight change, without adverse effects on quality of life. CONCLUSIONS: Sustained CR is feasible in nonobese humans. The effects of the achieved CR on correlates of human survival and disease risk factors suggest potential benefits for aging-related outcomes that could be elucidated by further human studies.
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The two-year CALERIE clinical trial of calorie restriction led to anti-aging effects including weight loss, improvement in cardiovascular risk parameters, and an increase in insulin sensitivity in healthy non-obese adults.
“A two-year-long clinical trial with CR called CALERIE (Comprehensive Assessment of Long Term Effects of Reducing Caloric Intake) led to a straightforward conclusion about the anti-aging effects, including weight loss, improvement in cardiovascular risk parameters, and an increase in insulin sensitivity in healthy non-obese adults [81].”
From Molecular Targets of 20-Hydroxyecdysone in Mammals, Mechanism of Action: Is It a Calorie Restriction Mimetic and Anti-Aging Compound? (2025) · cites this paper as [81]
The Adherence and Weight Loss and Cardiometabolic Risk Factors sections report weight loss, improved cardiovascular risk measures, and improved HOMA-IR, a measure of insulin resistance, in the two-year trial. But the Discussion describes effects on potential longevity-related factors and disease risks, not a straightforward demonstration of anti-aging effects in humans; it says further studies are needed to clarify the impact on health span and life span. Page numbers are unavailable in our copy. (LLM, conf=0.90)
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- Authors
- Ravussin, E., Redman, L. M., Rochon, J., Das, S. K., Fontana, L., Kraus, W. E., Romashkan, S., Williamson, D. A., Meydani, S. N., Villareal, D. T., Smith, S. R., Stein, R. I., Scott, T. M., Stewart, T. M., Saltzman, E., Klein, S., Bhapkar, M., Martin, C. K., Gilhooly, C. H., Holloszy, J. O., Hadley, E. C., Roberts, S. B., & for the CALERIE Study Group
- Affiliations
- Pennington Biomedical Research Center (US)
- Duke University (US)
- Tufts University (US)
- Washington University in St. Louis (US)
- National Institutes of Health (US)
- ORCID
- Venue
- The Journals of Gerontology Series A: Biological Sciences and Medical Sciences
- Publisher
- Oxford University Press (OUP)
- Published
- 2015-07-17
- Volume
- 70
- Issue
- 9
- Pages
- 1097-1104
- ISSN
- 1079-5006 (ISSN-L)
- 1758-535X
- PMC
- PMC4841173
- OpenAlex
- W2270526877
- Cited by
- 489
- References
- 39
- Citations by year
- 2026: 47 · 2025: 33 · 2024: 46 · 2023: 39 · 2022: 55 · 2021: 46 · 2020: 50 · 2019: 35 · 2018: 45 · 2017: 42 · 2016: 37 · 2015: 13
- FWCI
- 17.52
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Journals of Gerontology Series A (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Institutional Research Information System (Università degli Studi di Brescia) (submittedVersion)
- Funders
- National Institutes of Health
- National Institute on Aging (U01AG020478, U01AG020487, U24AG047121, U01AG020480, U01AG022132)
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK098722, P30DK072476)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Aging › Genetics, Aging, and Longevity in Model Organisms
- Health Sciences › Medicine › Physiology › Dietary Effects on Health
- Health Sciences › Medicine › Geriatrics and Gerontology › Sirtuins and Resveratrol in Medicine
- Keywords
- caloric restriction, longevity, healthspan, resting metabolic rate, energy expenditure, triiodothyronine, TNF-α, core body temperature, cardiometabolic risk factors, weight loss, quality of life, aging, non-obese adults
- MeSH terms
- Adult, Basal Metabolism, Blood Glucose, Blood Pressure, Body Temperature, C-Reactive Protein, Energy Intake, Feasibility Studies, Female, Humans, Lipids, Longevity, Male, Middle Aged, Time Factors, Triiodothyronine, Tumor Necrosis Factor-alpha, Weight Loss, Caloric Restriction, Young Adult
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