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

NCT07378787 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-01-30

No results posted yet for this study

Summary

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.

Adhere to a tailored Low Glycaemic Index Mediterranean Diet and track meals using the Nutrium app.

Attend study visits at the University of Nicosia at Week 0, Week 12, and Week 24 for various assessments.

Provide biological samples, including blood samples at five specific intervals and stool samples at Week 0 and Week 12.

Complete multiple questionnaires regarding diet, lifestyle, sleep quality, physical activity, tender and swollen joints, and quality of life.

Undergo physical and cognitive assessments, such as CNS Vital Signs tests, blood pressure measurements, and body composition analysis.

The two groups will be compared to understand if the intervention improves outcomes and can thus be applied in this population group.

Conditions

Interventions

OTHER

Time-Restricted Low-Glycaemic Index Diet

The combination of a 16:8 Time-Restricted eating period with a low glycaemic index Mediterranean diet

Sponsors & Collaborators

  • Digital Diet Clinic Ltd

    collaborator UNKNOWN

  • GENOS LIMITED

    collaborator UNKNOWN

  • University of Nicosia

    lead OTHER

Principal Investigators

  • Elena Philippou, PhD · University of Nicosia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-17
Primary Completion
2029-01-20
Completion
2029-01-20

Countries

  • Croatia
  • Cyprus

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07378787 on ClinicalTrials.gov