A diet program combining intermittent energy restriction and the Mediterranean diet
Effects of Intermittent Energy Restriction on Intra-Abdominal Fat and the Gut Microbiome: A Randomized Trial
This study is testing whether a diet that combines intermittent energy restriction with the Mediterranean diet can help middle-aged adults with high belly fat lose weight and improve their health compared to a daily diet plan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 35 Years to 69 Years |
| Sex | All |
| Sponsor | University of Hawaii Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Honolulu, Hawaii) |
| Trial ID | NCT05132686 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a 24-week randomized trial comparing intermittent energy restriction (IER) combined with the Mediterranean diet (MED) to a daily energy restriction (DER) approach among 260 middle-aged adults with high visceral fat. Participants will be randomly assigned to either the IER+MED group, which follows a specific eating pattern of energy restriction for two days a week, or the MED/DER group, which maintains a daily energy restriction. The trial aims to assess reductions in abdominal visceral fat, liver fat, and overall adiposity, as well as the impact on cancer-related biomarkers and gut microbiome. The study is designed to include a diverse population, focusing on East-Asian, Native Hawaiian, and white ethnicities.
Who should consider this trial
Good fit: Ideal candidates are middle-aged adults aged 35-69 with a BMI between 25-40 kg/m2 and high visceral fat levels.
Not a fit: Patients with serious health issues, pregnancy, or contraindications to MR imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective dietary approach for reducing visceral fat and improving metabolic health in at-risk populations.
How similar studies have performed: Previous studies have shown promising results for intermittent energy restriction and Mediterranean diets, but this specific combination is being rigorously tested for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Honolulu, Hawaii
- University of Hawaii Cancer Center — Honolulu, Hawaii, United States (Recruiting)
Study contacts
- Principal investigator: Loic Le Marchand, MD, PhD — University of Hawaii Cancer Research Center
- Study coordinator: Carol J Boushey, PhD, RDN
- Email: cjboushey@cc.hawaii.edu
- Phone: 765-404-8366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.