16:8 time-restricted eating with a low glycaemic-index Mediterranean diet for perimenopausal and menopausal women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Nicosia
  Nicosia, Engomi, Cyprus Recruiting
• Genos Ltd
  Zagreb, Croatia Active not recruiting

Study contacts

• Principal investigator: Elena Philippou, PhD — University of Nicosia
• Study coordinator: Elena Philippou, PhD
• Email: philippou.e@unic.ac.cy
• Phone: +35799611272

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hop extract vs soy isoflavone for menopausal symptoms

  This study tests whether a full-spectrum hop extract helps reduce menopausal mood symptoms better than soy isoflavones in peri- and postmenopausal women.

  Recruiting Menoclinica by Palacios · Madrid, Madrid · NCT07904390

• Lifestyle changes to ease menopausal symptoms, sleep problems, and anxiety

  Researchers are testing whether a structured lifestyle education program helps perimenopausal and postmenopausal women see fewer menopausal symptoms, better sleep, and less anxiety compared to usual care.

  Recruiting Konya Beyhekim Training and Research Hospital · Konya, Konya · NCT07860645

• CARAMEL: Personalizing Heart Risk in Women 40–60

  This observational study tests a personalized cardiovascular risk-stratification approach for women aged 40–60 using multi-source data and a digital self-management tool.

  Recruiting at 3 sites Biogipuzkoa Health Research Institute · Bogotá and 5 other locations · NCT07695376

• Samphire Guided Care for Wellbeing at Work

  This study tests a 12-week digital program with at-home neuromodulation to see if it helps women with menstrual or perimenopausal symptoms feel better at work and in daily life.

  Recruiting Samphire Group, Inc. · San Francisco, California · NCT07679074

• Low-level laser acupuncture to improve body shape and composition in overweight menopausal women

  This trial will test whether adding low-level multi-acupoint laser acupuncture to WHO-recommended diet and exercise helps overweight or obese menopausal women lose weight and improve body composition.

  Recruiting Chang Gung Memorial Hospital · Keelung, Taiwan · NCT07472881

• Hemp-derived cannabinoids for menopause and perimenopause symptom relief

  This will try hemp-derived cannabinoids versus placebo to see if they reduce physical and psychological symptoms in women aged 40–60 going through perimenopause or menopause.

  Recruiting Phase 2 Washington State University · Pullman, Washington · NCT07393672

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.