An interventional study of Time-Restricted Low-Glycaemic Index Diet in Late-perimenopause, Menopause and Perimenopause, sponsored by University of Nicosia. Recruiting at 2 sites in 2 countries. Open to female participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by University of Nicosia · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease (AD). Note: (Self-reported memory complaints are allowed).
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.
Other: Time-Restricted Low-Glycaemic Index Diet
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.
The combination of a 16:8 Time-Restricted eating period with a low glycaemic index Mediterranean diet
Also known as: intermittent fasting, low glycaemic diet, Mediterranean diet, 16:8
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
Time frame: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period
Cognitive function
Cognitive function using CNS Vital Signs assessments, including visual, verbal and composite memory, reaction time, executive function, complex attention and cognitive flexibility
Time frame: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period
Insulin resistance
Fasting glucose and insulin to assess insulin resistance using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Time frame: Week 0 and Week 12 for the intervention period
Lipid profile
Total cholesterol, LDL and HDL cholesterol, Triglyceride concentration, the triglyceride-to-HDL (TG/HDL) ratio will be calculated as a predictive marker for cardiovascular risk
Time frame: Week 0 and Week 12 for the intervention period
C-reactive protein (CRP)
CRP concentration to assess inflammation
Time frame: Week 0 and Week 12 for the intervention period
IgG N-glycome composition analysis to assess GlycanAge
The IgG N-glycome composition analysis will be used to measure biological ageing and systemic inflammation by analysing glycans attached to immunoglobulin G (IgG) antibodies in participants' blood samples using high-performance liquid chromatography (HPLC).
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
Body weight will be measured using minimal clothing. Height will be measured using a standard stadiometer. BMI will be calculated as weight in kg divided by height in metres squared
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
Body composition analysis using Bioelectrical Impedance Analysis in the fasted state to assess % body fat, body fat mass, fat-free mass, skeletal muscle mass and visceral fat
Time frame: Week 0 and Week 12 for the intervention phase and Week 24 for the follow-up phase
Gut microbiome
Gut microbiome will be assessed by performing phyla-level PCR analysis on the stool sample
Time frame: Week 0 and Week 12 for the intervention period
Blood pressure
Blood pressure will be assessed using standard methods
Time frame: Week 0 and Week 12 of the intervention period and Week 24 of the follow-up period
Sleep duration and quality
Subjective assessment of sleep duration and quality using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period
Tender and swollen joint count
The participant's number of tender and swollen joints will be self-assessed by providing a diagram to the participant, where they can mark any tender and/or swollen joints.
Time frame: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period
Global Health
Global Health will be assessed using the PROMIS® Scale v1.2 - Global Health which evaluates key domains including global physical health, global mental health, physical function, fatigue, pain interference, emotional distress, social health, and quality of life through Likert-scale items.
Time frame: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period
Physical activity assessment
Assessment of physical activity will be done using the Physical Activity Questionnaire - Short Form (IPAQ-SF) (confounding outcome)
Time frame: 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
Energy, macronutrient intake, dietary glycaemic index and timing of eating will be assessed via the Nutrium application. Adherence to the intervention will be assessed via 3-5 day food diaries through the Nutrium app.
Time frame: 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
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf
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