Time-Restricted Eating in Combination With a Low Glycaemic Index Diet on Cognitive Function, Biological Ageing and Metabolic Health in Perimenopause and Menopause.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Time-Restricted Low-Glycaemic Index Diet.
- Who it may be relevant to
- Registry conditions: Late-perimenopause, Menopause, Perimenopause. Basic parameters: 45 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia, Cyprus
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Detailed description
This randomized controlled trial will run over a period of 24 weeks (6 months) and will be divided into two main phases: a 12-week intervention phase followed by a 12- week follow-up phase designed to assess long-term adherence and health outcomes. The participants will be randomized to one of two groups: the intervention group of a Time-Restricted Eating combined with a Low Glycaemic Index diet (TRE-LGI) group, and the control group which will not receive any dietary intervention.
During the intervention phase (Week 0 to Week 12), participants randomized to the TRE-LGI group will follow a structured eating plan. They will be instructed to consume all their meals within an 8-hour eating window each day and adhere to a low glycaemic index Mediterranean-style diet. Participants randomized to the control group will not receive any dietary intervention but will continue to be monitored for study purposes.
Assessments will be conducted at three time points during this phase. At baseline (Week 0), participants will complete a full set of evaluations, including the online Computerised Neurocognitive Testing tool CNS Vital Signs, metabolic markers (insulin sensitivity, and lipid profiles, C-reactive protein (CRP), BDNF assessment using Enzyme-Linked Immunosorbent Assay (ELISA) Test, biological ageing assessment using the N-glycome analysis (GlycanAge test), gut microbiome analysis from stool samples, body composition, blood pressure, waist circumference, sleep quality using the Pittsburgh Sleep Quality Index (PSQI), physical activity using the International Physical Activity Questionnaire-Short Form IPAQ-SF, tender and swollen joint count and Global Health using the PROMIS® Scale v1.2 - Global Health.
At Week 6, only the N-glycome composition analysis (GlycanAge) will be repeated to monitor changes in biological ageing.
At Week 12, all baseline assessments will be repeated to measure the effects of the intervention.
The follow-up phase, spanning from week 12-24, will focus on evaluating the participants' ability to sustain the dietary practices achieved during the intervention period without receiving further active dietary guidance. Monitoring will continue to measure the longer-term effects on cognitive, metabolic, and biological health outcomes.
At Week 18, participants will undergo N-glycome composition analysis (GlycanAge) to continue monitoring biological ageing.
At Week 24, a final comprehensive assessment will be conducted, including cognitive function (CNS Vital Signs), BDNF Test, N-glycome analysis, body composition using BIA, BMI, blood pressure, waist circumference, and sleep quality (PSQI), physical activity (IPAQ-SF), tender and swollen joint count, and Global Health PROMIS questionnaire.
Participants in the control group will complete the same assessments at each scheduled time point, allowing for direct comparisons; however, they will not undergo any dietary intervention throughout the study.
Interventions
- Other Time-Restricted Low-Glycaemic Index Diet
The combination of a 16:8 Time-Restricted eating period with a low glycaemic index Mediterranean diet
Primary outcome measures
- Brain-derived neurotrophic factor concentration [Time frame: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period]
Secondary outcome measures (12)
- Cognitive function [Time frame: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period]
- Insulin resistance [Time frame: Week 0 and Week 12 for the intervention period]
- Lipid profile [Time frame: Week 0 and Week 12 for the intervention period]
- C-reactive protein (CRP) [Time frame: Week 0 and Week 12 for the intervention period]
- IgG N-glycome composition analysis to assess GlycanAge [Time frame: 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.]
- Anthropometric measurements: Body weight, height, and calculation of the Body Mass Index [Time frame: Week 0 and weekly thereafter until Week 24 for body weight and BMI, Week 0: Body height]
- Body composition analysis using Bioelectrical Impedance Analysis [Time frame: Week 0 and Week 12 for the intervention phase and Week 24 for the follow-up phase]
- Gut microbiome [Time frame: Week 0 and Week 12 for the intervention period]
- Blood pressure [Time frame: Week 0 and Week 12 of the intervention period and Week 24 of the follow-up period]
- Sleep duration and quality [Time frame: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period]
- Tender and swollen joint count [Time frame: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period]
- Global Health [Time frame: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Croatia · 1 center
- Genos Ltd — Zagreb
Cyprus · 1 center
- University of Nicosia — Nicosia
Publications
- 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 39992029
Identifiers
NCT: NCT07378787 · EEBK/EΠ/2025/52