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Late-perimenopauseNutriAgeNCT07378787

Time-Restricted Eating in Combination With a Low Glycaemic Index Diet on Cognitive Function, Biological Ageing and Metabolic Health in Perimenopause and Menopause.

A study testing Time-Restricted Low-Glycaemic Index Diet in people with Late-perimenopause and Menopause, run by University of Nicosia at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Late-perimenopause, Menopause, Perimenopause
What is being tested?
Time-Restricted Low-Glycaemic Index Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesin 2 countries
Study dates
17 Jan 2026to 20 Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Elena Philippou, PhD contact

+35799611272

philippou.e@unic.ac.cy

Francesco Colelli, MSc contact

francesco92colelli@gmail.com

2 sites in 2 countries

Croatia1 site
  • Genos Ltd

    Zagreb, 10000

    Active, not recruiting

Other trials in Croatia

Cyprus1 site, 1 recruiting
  • University of Nicosia

    Nicosia, Engomi, 1700

    Elena Philippou, PhD, +35799611272, philippou.e@unic.ac.cy

    Fransesco Colelli, MSc, francesco92colelli@gmail.com

    Recruiting

Other trials in Cyprus

About this study

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.

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.

Read more

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.

Read the 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.

Being tested
Time-Restricted Low-Glycaemic Index Diet
Keywords
Peri-menopause, menopause, intermittent fasting, low glycaemic-index diet, women, time-restricted eating, biological ageing, metabolic markers, cognitive function, cognition, tender joints, swollen joints, nutrition, microbiome, Mediterranean diet, GlycanAge, randomized controlled trial, BDNF, insulin resistance, middle-aged
Medical subject headings
Intermittent Fasting, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time-Restricted Low-Glycaemic Index DietOther

    Also called intermittent fasting, low glycaemic diet, Mediterranean diet, 16:8

    The combination of a 16:8 Time-Restricted eating period with a low glycaemic index Mediterranean diet

Study groups in NCT07378787
Study groupRoleWhat they receive
Time-Restricted Low Glycaemic Index DietExperimentalParticipants 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.
Receives: Other: Time-Restricted Low-Glycaemic Index Diet
Control groupNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period

Secondary outcomes (12)
  1. Cognitive function

    Cognitive function using CNS Vital Signs assessments, including visual, verbal and composite memory, reaction time, executive function, complex attention and cognitive flexibility

    Measured: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period

  2. Insulin resistance

    Fasting glucose and insulin to assess insulin resistance using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).

    Measured: Week 0 and Week 12 for the intervention period

  3. 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

    Measured: Week 0 and Week 12 for the intervention period

  4. C-reactive protein (CRP)

    CRP concentration to assess inflammation

    Measured: Week 0 and Week 12 for the intervention period

  5. 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).

    Measured: 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.

  6. 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

    Measured: Week 0 and weekly thereafter until Week 24 for body weight and BMI, Week 0: Body height

  7. 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

    Measured: Week 0 and Week 12 for the intervention phase and Week 24 for the follow-up phase

  8. Gut microbiome

    Gut microbiome will be assessed by performing phyla-level PCR analysis on the stool sample

    Measured: Week 0 and Week 12 for the intervention period

  9. Blood pressure

    Blood pressure will be assessed using standard methods

    Measured: Week 0 and Week 12 of the intervention period and Week 24 of the follow-up period

  10. Sleep duration and quality

    Subjective assessment of sleep duration and quality using the Pittsburgh Sleep Quality Index (PSQI)

    Measured: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period

  11. 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.

    Measured: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period

  12. 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.

    Measured: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2026
  2. Study start17 Jan 2026
  3. Primary completion20 Jan 2029 (estimated)
  4. Study completion20 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07378787
Sponsor's protocol ID
EEBK/EΠ/2025/52
Acronym
NutriAge
Status last verified
Jan 2026
First submitted
23 Jan 2026
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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.

    PubMed 39992029

Questions about this trial

What is this clinical trial studying?

A study testing Time-Restricted Low-Glycaemic Index Diet in people with Late-perimenopause and Menopause, run by University of Nicosia at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Croatia, Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elena Philippou, PhD (+35799611272, philippou.e@unic.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain-derived neurotrophic factor concentration (time frame: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07378787, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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