Randomized controlled trial2025Open access

Effect of a ketogenic diet, time-restricted eating, or alternate-day fasting on weight loss in adults with obesity: a randomized clinical trial

Martínez-Montoro JI, Bandera B, Gutiérrez-Bedmar M, Gómez-Pérez AM, Macías-González M, Moreno-Indias I, Tinahones FJ

BMC medicine · 3 citations

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Independent funding
Government
Servicio Andaluz de Salud
Government
Instituto de Salud Carlos III
Grants
Instituto de Salud Carlos III (C-0029-2014); Instituto de Salud Carlos III (PI18/01160); Servicio Andaluz de Salud (B-0033-2014); Instituto de Salud Carlos III (CPII21-00013); Servicio Andaluz de Salud (RC-0001-2018); Servicio Andaluz de Salud (PI18/01160); Servicio Andaluz de Salud (C-0029-2014); Instituto de Salud Carlos III (JR24/00006); Instituto de Salud Carlos III (CM22/00217)

Based on 2 listed funder(s) and full-text disclosure statement.

Publication

Published
2025-07-01 · BMC Med · vol. 23 · issue 1 · p. 368
Publisher
BioMed Central
Cited
13 citations · more than 98% of similar papers · 6.9× the field average
Impact
Top 10% most cited in its field
References
38 works
Access
Open access (journal) · CC-BY-NC-ND
Research areas
Dietary Effects on Health · Diet and metabolism studies · Enhanced Recovery After Surgery
Keywords
Medicine, Ketogenic diet, Weight loss, Obesity, Randomized controlled trial, Intermittent fasting, Clinical trial, Pediatrics, Internal medicine, Physical therapy, Epilepsy, Psychiatry
MeSH
humans, obesity, weight loss, body mass index, treatment outcome, caloric restriction, fasting, adult, middle aged, female, male, diet, ketogenic

7 authors

From ES

  • José Ignacio Martínez‐Montoro · correspondingInstituto de Salud Carlos III; Andalusian Centre for Nanomedicine and Biotechnology; Hospital Clínico Universitario Virgen de la Victoria; Instituto de Investigación Biomédica de Málaga; Universidad de Málaga
  • Borja BanderaInstituto de Salud Carlos III; Hospital Clínico Universitario Virgen de la Victoria; Instituto de Investigación Biomédica de Málaga; Universidad de Málaga
  • Mario Gutiérrez‐BedmarInstituto de Salud Carlos III; Centro de Investigación en Red en Enfermedades Cardiovasculares; Centro de Investigación Biomédica en Red; Instituto de Investigación Biomédica de Málaga; Universidad de Málaga
  • Ana María Gómez‐PérezInstituto de Salud Carlos III; Hospital Clínico Universitario Virgen de la Victoria; Instituto de Investigación Biomédica de Málaga
  • Manuel Macías‐GonzálezInstituto de Salud Carlos III; Hospital Clínico Universitario Virgen de la Victoria; Instituto de Investigación Biomédica de Málaga
  • Isabel Moreno‐Indias · correspondingInstituto de Salud Carlos III; Hospital Clínico Universitario Virgen de la Victoria; Instituto de Investigación Biomédica de Málaga

Abstract

Background

Studies evaluating the effects of novel, alternative dietary approaches for weight loss compared with the Mediterranean diet (MedDiet) are lacking. We aimed to evaluate the effects of diets with varying ketogenic potential, i.e., a very-low carbohydrate diet (ketogenic diet, KD), time-restricted eating (TRE), and modified alternate-day fasting (mADF) on weight loss in obesity, compared with a MedDiet.

Methods

Three-month, parallel-arm, randomized clinical trial including 160 adults with obesity. Participants were randomized to 1 of 5 groups: control (MedDiet), KD, early TRE (eTRE), late TRE (lTRE), or mADF. All diets were calorie-restricted. The primary outcome was differences in weight loss from baseline to 3 months between a calorie-restricted MedDiet and each of the four remaining calorie-restricted dietary interventions. Secondary outcomes included change in body mass index, body composition, and cardiometabolic risk factors.

Results

The mean age was 45.7 years (SD 10.7), and 70.6% were women. One hundred forty participants completed the study. Significant differences in weight loss from baseline to 3 months were found between KD and the control group [- 3.78 kg (- 5.65 to - 1.91 kg)], between mADF and the control group [- 3.14 kg (- 4.98 to - 1.30 kg)], and between lTRE and the control group [- 2.27 kg (- 4.13 to - 0.40 kg)], but not between eTRE and the control group [- 1.22 kg (- 3.07 to 0.64 kg)].

Conclusions

These results suggest that a calorie-restricted KD, mADF, or lTRE may be more effective for weight loss than a calorie-restricted MedDiet in obesity. Further research is needed to evaluate the long-term feasibility and efficacy of these dietary interventions compared with the MedDiet.

Trial registration

ClinicalTrials.gov (NCT04453150).

Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-ND).

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