Time-Restricted Eating in Combination With a Low Glycaemic Index Diet on Cognitive Function, Biological Ageing and Metabolic Health in Perimenopause and Menopause.
NutriAge
The Effect of Time-Restricted Eating in Combination With a Low Glycaemic Index Diet on Cognitive Function, Markers of Biological Age and Metabolic Health in Late-Perimenopausal and Menopausal Women: a Randomized Controlled Trial. The NutriAge Trial.
1 other identifier
interventional
72
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2026
CompletedFirst Submitted
Initial submission to the registry
January 23, 2026
CompletedFirst Posted
Study publicly available on registry
January 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 20, 2029
January 30, 2026
January 1, 2026
3 years
January 23, 2026
January 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain-derived neurotrophic factor concentration
Changes between the intervention and control group in the concentration of brain-derived neurotrophic factor assessed by Enzyme-linked Immunosorbent Assay
Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period
Secondary Outcomes (12)
Cognitive function
Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period
Insulin resistance
Week 0 and Week 12 for the intervention period
Lipid profile
Week 0 and Week 12 for the intervention period
C-reactive protein (CRP)
Week 0 and Week 12 for the intervention period
IgG N-glycome composition analysis to assess GlycanAge
The test will be conducted at Week 0, 6, 12, 18, and 24 to monitor progressive changes in biological ageing throughout the 6-month study period.
- +7 more secondary outcomes
Other Outcomes (2)
Physical activity assessment
Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period
Nutritional Assessment and adherence to the dietary intervention
Intervention group: weekly monitoring between Week 1 to Week 12. Control group: 3-day food diary at week 1, week 6 and Week 12. All participants: 3-day food diary at Week 18 and Week 24. Adherence to the intervention: week 1, 6, 12, 24
Study Arms (2)
Time-Restricted Low Glycaemic Index Diet
EXPERIMENTALParticipants 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.
Control group
NO INTERVENTIONThe 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.
Interventions
The combination of a 16:8 Time-Restricted eating period with a low glycaemic index Mediterranean diet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nicosialead
- Digital Diet Clinic Ltdcollaborator
- GENOS LIMITEDcollaborator
Study Sites (2)
Genos Ltd
Zagreb, 10000, Croatia
University of Nicosia
Nicosia, Engomi, 1700, Cyprus
Related Publications (1)
Demetriou CA, Hileti D, Onisiphorou E, Kazafanioti C, Alogakos M, Vardakastani D, Christofidou E, Andreou EP, Giannaki CD, Stavrinou PS, Philippou P, Constantinidou F, Philippou E. Associations Between Chrono-Nutrition Behaviours and Cognitive Function in Middle-Aged Adults: The NUTRICO Cross-Sectional Cohort Study. Nutr Bull. 2025 Jun;50(2):262-277. doi: 10.1111/nbu.70000. Epub 2025 Feb 24.
PMID: 39992029BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elena Philippou, PhD
University of Nicosia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Nutrition-Dietetics
Study Record Dates
First Submitted
January 23, 2026
First Posted
January 30, 2026
Study Start
January 17, 2026
Primary Completion (Estimated)
January 20, 2029
Study Completion (Estimated)
January 20, 2029
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available beginning 6 months after the publication of the primary manuscript and ending 10 years after the study start date.
- Access Criteria
- De-identified individual participant data (IPD) and supporting documents (Study Protocol and SAP) will be made available to qualified academic researchers upon request. To gain access, researchers must submit a detailed research proposal and a methodologically sound analysis plan for review by the NutriAge trial steering committee. Approval is contingent on the scientific merit of the proposal and the feasibility of the analysis. Before data transfer, the requesting institution must execute a Data Use Agreement (DUA) to ensure strict adherence to GDPR standards and to prevent any attempts at participant re-identification.
De-identified individual participant data underlying the results reported in the published article (including cognitive test scores, metabolic markers, and N-glycome markers) will be made available to qualified researchers. Data will be shared only after a formal request and upon approval of a methodologically sound research proposal. To protect participant privacy in accordance with GDPR and the Cyprus National Bioethics Committee, all shared data will be coded, and researchers must sign a Data Use Agreement (DUA) ensuring they will not attempt to re-identify any individual.