Actively Recruiting

Phase Not Applicable
Age: 45Years - 75Years
FEMALE
Healthy Volunteers
NCT07378787

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

Led by University of Nicosia · Updated on 2026-01-30

72

Participants Needed

2

Research Sites

157 weeks

Total Duration

On this page

Sponsors

U

University of Nicosia

Lead Sponsor

D

Digital Diet Clinic Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 45Years - 75Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women in late perimenopausal or menopausal status (late perimenopause defined as two or more skipped cycles and at least 60 days of no menstrual cycle; menopause defined as 12 consecutive months without a menstrual cycle)
  • BMI of 23 kg/m2 or higher
  • Age between 45 and 75 years old
  • If using medication, dose must have been stable for the previous 12 months
  • Able to use technology and follow the dietary plan
Not Eligible

You will not qualify if you...

  • Diagnosis of mild cognitive impairment or Alzheimer's disease (self-reported memory complaints allowed)
  • Use of hormone replacement therapy (HRT)
  • Medical conditions significantly affecting cognitive or metabolic function, including type 1 diabetes, severe metabolic disorders, cardiovascular disease, neurodegenerative conditions, diagnosed eating disorders, or severe mental health conditions
  • Currently enrolled in another intervention study
  • Severe food allergies or dietary restrictions preventing adherence to the study diet
  • History of substance abuse

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Genos Ltd

Zagreb, Croatia, 10000

Active, Not Recruiting

2

University of Nicosia

Nicosia, Engomi, Cyprus, 1700

Actively Recruiting

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Research Team

E

Elena Philippou, PhD

CONTACT

F

Francesco Colelli, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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