Time-Restricted Eating in Combination With a Low Glycaemic Index Diet on Cognitive Function, Biological Ageing and Metabolic Health in Perimenopause and Menopause.

What this trial studies

The goal of this randomised controlled trial is to investigate whether Time-Restricted Eating (TRE) combined with a Low Glycaemic Index Mediterranean Diet can improve cognitive function, metabolic health, and biological ageing in late perimenopausal and menopausal women aged 45-75 years with a BMI ≥23 kg/m². It will consist of a 12-week intervention followed by a 12 week follow-up period. Researchers will compare a group following the 16:8 time-restricted eating schedule and Low Glycaemic Index Mediterranean Diet to a control group (waiting list) receiving no dietary or meal-timing instructions to determine if these dietary strategies influence cognitive function, assessed via brain-derived neurotropic factor (BDNF) and cognitive function tests, metabolic outcomes, biological age, the gut microbiome, tender and swollen joint count and global health. Participants will: Follow a 16:8 time-restricted eating schedule (eating within an 8-hour window and fasting for 16 hours) if assigned to the intervention group.

Conditions in scope

• Late-perimenopause
• Menopause
• Perimenopause

Interventions

• Time-Restricted Low-Glycaemic Index Diet (Other) — The combination of a 16:8 Time-Restricted eating period with a low glycaemic index Mediterranean diet

Who can join

Women only · Ages 45 Years to 75 Years · Accepts healthy volunteers.

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2026-01-17
• Primary completion: 2029-01-20
• Last update posted: 2026-01-30
• First posted: 2026-01-30

Sponsor & contact

Lead sponsor: University of Nicosia (Other)

Collaborators: Digital Diet Clinic Ltd, GENOS LIMITED

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Brain-derived neurotrophic factor concentration (Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period)
  Changes between the intervention and control group in the concentration of brain-derived neurotrophic factor assessed by Enzyme-linked Immunosorbent Assay

Related ClearedRx care

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