16:8 time-restricted eating with a low glycaemic-index Mediterranean diet for perimenopausal and menopausal women
The Effect of Time-Restricted Eating in Combination With a Low Glycaemic Index Diet on Cognitive Function, Markers of Biological Age and Metabolic Health in Late-Perimenopausal and Menopausal Women: a Randomized Controlled Trial. The NutriAge Trial.
This trial will test whether a 16:8 time-restricted eating schedule combined with a low glycaemic-index Mediterranean diet can improve thinking, metabolic health, and biological ageing in women aged 45–75 in late perimenopause or menopause with BMI ≥23.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | Female |
| Sponsor | University of Nicosia Academic / other |
| Locations | 2 sites (Zagreb and 1 other locations) |
| Trial ID | NCT07378787 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled 24-week trial with a 12-week intervention period followed by a 12-week follow-up to monitor longer-term adherence and outcomes. Participants are randomized to a combined intervention (16:8 time-restricted eating plus a low glycaemic-index Mediterranean-style diet) or a waiting-list control with no dietary instructions. Key outcomes measured at baseline, week 12 and week 24 include cognitive testing and BDNF, metabolic markers (insulin sensitivity, lipids, CRP), biological age via N-glycome (GlycanAge), gut microbiome from stool, body composition, blood pressure, waist circumference, sleep quality and joint counts. The trial requires participants to follow a daily 8-hour eating window and the prescribed dietary pattern, with monitoring using digital tools and in-person visits for biological sample collection.
Who should consider this trial
Good fit: Women aged 45–75 in late perimenopause or menopause with BMI ≥23 kg/m², on stable medication doses for the prior 12 months, able to use technology and follow a dietary plan, and not using hormone replacement therapy are ideal candidates.
Not a fit: People with diagnosed mild cognitive impairment or Alzheimer's disease, those on hormone replacement therapy, or those with major metabolic, cardiovascular, neurodegenerative, severe eating or psychiatric disorders are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could offer a non-drug way to improve cognitive performance, metabolic health, and markers of biological ageing in perimenopausal and menopausal women.
How similar studies have performed: Previous small trials of time-restricted eating and Mediterranean-style or low‑GI diets have shown metabolic benefits and limited cognitive signals, but combining TRE with a low‑GI Mediterranean diet specifically in perimenopausal/menopausal women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women in late perimenopausal or menopausal status Note: Late perimenopause is defined as two or more skipped cycles and at least 60 days of amenorrhea. Recent blood tests showing elevated FSH levels support eligibility for late perimenopause. Menopause is defined as 12 consecutive months without a menstrual cycle. * BMI ≥23 kg/m2 * Age 45-75 years old * If using any medication, the dose should be stable for the previous 12 months * Able to use technology and follow the dietary plan Exclusion Criteria: * Diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease (AD). Note: (Self-reported memory complaints are allowed). * On hormone replacement therapy (HRT) * Medical conditions that significantly affect cognitive or metabolic function including diagnosis of type 1 diabetes, severe metabolic disorders, cardiovascular disease, or neurodegenerative conditions, diagnosed eating disorders or severe mental health conditions. * Currently enrolled in another intervention. * Severe food allergies or dietary restrictions that would prevent adherence to the study diet. * History of substance abuse.
Where this trial is running
Zagreb and 1 other locations
- Genos Ltd — Zagreb, Croatia (Active_not_recruiting)
- University of Nicosia — Nicosia, Engomi, Cyprus (Recruiting)
Study contacts
- Principal investigator: Elena Philippou, PhD — University of Nicosia
- Study coordinator: Elena Philippou, PhD
- Email: philippou.e@unic.ac.cy
- Phone: +35799611272
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.