Intermittent fasting may beat daily dieting for belly fat loss
NCT ID NCT05132686
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether intermittent fasting (eating very little two days a week) combined with a Mediterranean diet is better than a daily low-calorie diet for reducing belly fat and liver fat. About 260 adults aged 35-69 with excess belly fat will follow one of two diet plans for 24 weeks. The goal is to see which approach works best for weight loss and improving health markers.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 260 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 69 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 35-69 years old * BMI between 25-40 kg/m2 * Currently non-smoking * No serious health issues * Fully vaccinated for COVID-19 * Normal blood chemistry profile * East Asian (Chinese, Japanese, Korean), Filipino, Native Hawaiian/other Pacific Islander or white/European ancestry * Non-drinkers / low habitual drinkers, i.e., men ≤15 drinks per week, women ≤10 drinks per week * Volunteers living on the island of Oahu * For peri-menopausal women, the investigators will require that they had their last period at least 1 year before baseline) * DXA VAT ≥90 cm2 for men and ≥80 cm2 for women * Able to read, speak, and write in English Exclusion Criteria: * Pregnancy * Contraindication to MR imaging (e.g. pacemaker, claustrophobia, metal implants) * Previous surgery to remove any part of the small intestine, colon or rectum (e.g. ileostomy or colectomy) or an amputation of a leg or arm. * For women, taking any anti-estrogen medications (e.g tamoxifen, Nolvadex, Istubal, Valodex) * For men, taking any anti-androgen medications (e.g., Eulexin (flutamide); Anandron or Nilandron (nilutamide); Casodex (bicalutamide); Proscar or Propecia (finasteride); Avodart (dutasteride); or bexlosteride, izonsteride, turosteride, episteride). * Diagnosis of Type 1 diabetes or Type 2 diabetes and taking insulin for treatment * Diagnosis of thyroid conditions under treatment with hormones or medications. * Serious health issues such as dialysis, organ transplant, celiac disease, Crohn's disease, chronic liver disease, active case of hepatitis B or C, chronic kidney disease, or any condition that, in the opinion of the investigator, is a contraindication to participation. * Previous problem with fasting blood collection * Cannot exercise (walk) for up to 1hr/day Deferral Criteria : Volunteers with the following conditions will be called back after the specified duration: * Treatments in past 6 months: chemotherapy or radiation of abdomen/pelvis; corticosteroid hormones; prescription weight loss drugs; estrogen/androgen receptor blockers * Substantial weight change (\>20lbs) in past 6 months * Antibiotic use in past 3 months * Colonoscopy, sigmoidoscopy, colon irrigation/bowel cleaning in the past 3 months * MRI/CAT scan with contrast in the past 2 weeks
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States