A randomized pilot study comparing zero‐calorie alternate‐day fasting to daily caloric restriction in adults with obesity
Open accessAbstract
Objective: To evaluate the safety and tolerability of alternate‐day fasting (ADF) and to compare changes in weight, body composition, lipids, and insulin sensitivity index (Si) with those produced by a standard weight loss diet, moderate daily caloric restriction (CR). Methods: Adults with obesity (BMI ≥30 kg/m 2, age 18‐55) were randomized to either zero‐calorie ADF (n = 14) or CR (−400 kcal/day, n = 12) for 8 weeks. Outcomes were measured at the end of the 8‐week intervention and after 24 weeks of unsupervised follow‐up. Results: No adverse effects were attributed to ADF, and 93% completed the 8‐week ADF protocol. At 8 weeks, ADF achieved a 376 kcal/day greater energy deficit; however, there were no significant between‐group differences in change in weight (mean ± SE; ADF −8.2 ± 0.9 kg, CR −7.1 ± 1.0 kg), body composition, lipids, or Si. After 24 weeks of unsupervised follow‐up, there were no significant differences in weight regain; however, changes from baseline in % fat mass and lean mass were more favorable in ADF. Conclusions: ADF is a safe and tolerable approach to weight loss. ADF produced similar changes in weight, body composition, lipids, and Si at 8 weeks and did not appear to increase risk for weight regain 24 weeks after completing the intervention.
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Four trials documented no adverse events throughout the intervention period.
“Among them, four trials [34, 35, 57, 73] documented no adverse events throughout the intervention period.”
From Comparing caloric restriction regimens for effective weight management in adults: a systematic review and network meta-analysis (2024) · cites this paper as [35]
The Results, under Safety Assessments (page unavailable), report no significant changes in safety measures during the 8-week intervention and describe one unrelated gallbladder event after it ended. They do not explicitly document that no adverse events occurred during the intervention; unchanged safety measures are not the same as an absence of adverse events. (LLM, conf=0.83)
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- Authors
- Catenacci, V. A., Pan, Z., Ostendorf, D., Brannon, S., Gozansky, W. S., Mattson, M. P., Martin, B., MacLean, P. S., Melanson, E. L., & Troy Donahoo, W.
- Affiliations
- Colorado School of Public Health (US)
- Children's Hospital Colorado (US)
- Kaiser Permanente (US)
- National Institutes of Health (US)
- University of Colorado Anschutz (US)
- Department of Medicine, Division of Endocrinology, Metabolism, and Diabetes University of Colorado Anschutz Medical Campus Aurora Colorado USA
- Corresponding author
- Catenacci, Victoria A.
- ORCID
- Venue
- Obesity
- Publisher
- Wiley
- Published
- 2016-08-29
- Volume
- 24
- Issue
- 9
- Pages
- 1874-1883
- ISSN
- 1930-7381 (ISSN-L)
- 1930-739X
- PMC
- PMC5042570
- OpenAlex
- W2518536384
- Cited by
- 332
- References
- 39
- Citations by year
- 2026: 21 · 2025: 29 · 2024: 44 · 2023: 36 · 2022: 52 · 2021: 55 · 2020: 43 · 2019: 17 · 2018: 23 · 2017: 11 · 2016: 1
- FWCI
- 13.96
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Obesity (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (R21 AT002617‐02, NIH UL1 TR001082, NIH DK 048520)
- Topics
- Health Sciences › Medicine › Physiology › Dietary Effects on Health
- Health Sciences › Medicine › Physiology › Diet and metabolism studies
- Social Sciences › Psychology › Clinical Psychology › Eating Disorders and Behaviors
- Keywords
- alternate-day fasting, weight loss, body composition, fat mass, lean body mass, lipids, insulin sensitivity, weight regain, negative energy balance, safety and tolerability
- MeSH terms
- Adult, Body Composition, Body Weight, Energy Intake, Diet, Reducing, Fasting, Female, Humans, Male, Middle Aged, Obesity, Pilot Projects, Weight Loss, Treatment Outcome, Caloric Restriction
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