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.
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
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.
Parallel
Time-Restricted Low-Glycaemic Index Diet
Other interventionThe combination of a 16:8 Time-Restricted eating period with a low glycaemic index Mediterranean diet
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
Cognitive function
Cognitive function using CNS Vital Signs assessments, including visual, verbal and composite memory, reaction time, executive function, complex attention and cognitive flexibility
Insulin resistance
Fasting glucose and insulin to assess insulin resistance using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
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
C-reactive protein (CRP)
CRP concentration to assess inflammation
Physical activity assessment
Assessment of physical activity will be done using the Physical Activity Questionnaire - Short Form (IPAQ-SF) (confounding outcome)
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.
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