Menopause and cognitive impairment: A narrative review of current knowledge.
Délio Marques Conde, Roberto Carmignani Verdade, Ana L R Valadares...
https://pubmed.ncbi.nlm.nih.gov/34513605Actively Recruiting
Phase Not Applicable
Age: 45Years - 55Years
FEMALE
Healthy Volunteers
ID07481513
Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women
Led by American University of Beirut Medical Center · Updated on 2026-03-19
140
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore how intermittent fasting, specifically the 16/8 method, affects the mental health of women in the perimenopause stage. This phase, typically between ages 45 and 55, involves hormonal changes that can impact mood, sleep, cognition, and physical well-being. The study will include 98 women to compare mental health outcomes between those following intermittent fasting and those following standard dietary guidelines, helping to understand if intermittent fasting may improve mental health during this transition. Participants will be randomly assigned to one of two groups: the experimental group will follow a 16/8 intermittent fasting regimen, fasting for 16 hours daily and eating during an 8-hour window, supported by a fasting tracker and educational materials. The control group will follow Lebanese food-based dietary guidelines. The study spans six months with data collected at baseline and at 6, 12, and 24 weeks. Weekly calls will support adherence and monitor side effects such as fatigue or low blood sugar. Those experiencing severe distress will receive referrals and may be withdrawn. Women will have their mental health assessed using validated tools like the PHQ-9 for depression, GAD-7 for anxiety, and the Pittsburgh Sleep Quality Index for sleep quality, along with measures of body satisfaction, cognitive function, sexual health, and BMI. Data will be collected at several points throughout the study to track changes. Safety monitoring includes referral to free medical or mental health support as needed. Total participation lasts six months, with ongoing follow-up to evaluate the effect of intermittent fasting on mental wellbeing in perimenopausal women.
CONDITIONS
Brief Title
Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women
Who Can Participate
Age: 45Years - 55Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Women aged 45 to 55 years
- Currently in the perimenopausal stage as defined by STRAW criteria and confirmed using the Menopausal Rating Scale (MRS)
You will not qualify if you...
- Currently using hormone replacement therapy
- Diagnosed with severe medical conditions such as uncontrolled diabetes, heart disease, hypertension, cancer, or kidney disease
- Have a formal mental health diagnosis as defined by the DSM-5
- Experiencing any form of dementia
- Have had surgical menopause, premature ovarian failure, chemotherapy or radiotherapy, or are ovarian cancer survivors
- Currently pregnant, undergoing treatment for endometriosis, have significant thyroid disorders, or on any form of hormone therapy
- Do not speak English
- Score greater than 0 on question 9 of the PHQ-9 (including suicidal ideation) will lead to removal and referral for mental health support
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 24 weeks
Participants follow either a 16/8 intermittent fasting regimen or standard dietary guidelines to assess effects on mental health during perimenopause.
Weekly calls for participants in the fasting group to support adherence and monitor side effects; data collected at baseline, 6, 12, and 24 weeks
Trial Site Locations
Total: 1 location
1
American University of Beirut Medical Center
Beirut, Lebanon
Actively Recruiting
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Research Team
N
Nadia T Dandan, PsyD
S
Sara El Hajj, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Impact of fasting on stress systems and depressive symptoms in patients with major depressive disorder: a cross-sectional study.
Britta Stapel, Daniela Fraccarollo, Mechthild Westhoff-Bleck...
https://pubmed.ncbi.nlm.nih.gov/35538177Fasting Interventions for Stress, Anxiety and Depressive Symptoms: A Systematic Review and Meta-Analysis.
Elisa Berthelot, Damien Etchecopar-Etchart, Dimitri Thellier...
https://pubmed.ncbi.nlm.nih.gov/34836202Intermittent Fasting and Human Metabolic Health.
Ruth E Patterson, Gail A Laughlin, Andrea Z LaCroix...
https://pubmed.ncbi.nlm.nih.gov/25857868