NCT07378787 Time-Restricted Eating in Combination With a Low Glycaemic Index Diet on Cognitive Function, Biological Ageing and Metabolic Health in Perimenopause and Menopause.
| NCT ID | NCT07378787 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nicosia |
| Condition | Late-perimenopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2026-01-17 |
| Primary Completion | 2029-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2026-01-17 with a primary completion date of 2029-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Elena Philippou, PhD
PRINCIPAL INVESTIGATOR
University of Nicosia
Frequently Asked Questions
Who can join the NCT07378787 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 75 Years, studying Late-perimenopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07378787 currently recruiting?
Yes, NCT07378787 is actively recruiting participants. Contact the research team at philippou.e@unic.ac.cy for enrollment information.
Where is the NCT07378787 trial being conducted?
This trial is being conducted at Zagreb, Croatia, Nicosia, Cyprus.
Who is sponsoring the NCT07378787 clinical trial?
NCT07378787 is sponsored by University of Nicosia. The principal investigator is Elena Philippou, PhD at University of Nicosia. The trial plans to enroll 72 participants.