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

Sponsor
University of Nicosia
Study ID
NCT07378787
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 75 Years
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

First listed
Jan 30, 2026
Start date
Jan 17, 2026
Status verified
Jan 2026
Primary completion
Jan 20, 2029
Completion
Jan 20, 2029

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Time-Restricted Low Glycaemic Index Diet
    Participants in the Time-Restricted-Low-Glycaemic Index group will follow a 16:8 intermittent fasting regimen, where all meals are consumed within an 8-hour eating window. Their diet will also consist of low-glycaemic index foods following the principles of the Mediterranean diet. They will provided with individualized dietary plans through the Nutrium App and followed up regularly through the app.
  • No Intervention: Control group
    The Control Group will receive no dietary intervention during the 6-month trial but will be placed on a waiting list for future guidance if requested. Their dietary intake will be recorded through the Nutrium App.

Primary Outcome Measure

Brain-derived neurotrophic factor concentration [ Time Frame: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period ]

Central Contacts

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