Actively Recruiting
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
Eligibility Criteria
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
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
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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