Intermittent fasting for mental health during perimenopause
Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women
This trial will see if a 16/8 intermittent fasting plan helps improve mental health for women aged 45–55 who are in perimenopause.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 45 Years to 55 Years |
| Sex | Female |
| Sponsor | American University of Beirut Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beirut) |
| Trial ID | NCT07481513 on ClinicalTrials.gov |
What this trial studies
This six-month randomized controlled trial at the American University of Beirut Medical Center will randomly assign about 98 perimenopausal women aged 45–55 to either a 16/8 intermittent fasting schedule or to follow Lebanese food-based dietary guidelines. Mental health outcomes will be measured with validated questionnaires and other standardized tools, and group differences will be analyzed using independent t-tests. Key exclusions include current hormone replacement therapy, uncontrolled major medical conditions, current DSM-5 psychiatric diagnoses, dementia, surgical menopause, pregnancy, and non–English speakers. The study aims to determine whether intermittent fasting offers a practical non-pharmacologic approach to improve mood, sleep, and cognitive symptoms during the perimenopausal transition.
Who should consider this trial
Good fit: Women aged 45–55 in perimenopause by STRAW criteria and the Menopausal Rating Scale, who speak English, are not on hormone therapy, and do not have major uncontrolled medical or current formal psychiatric conditions.
Not a fit: Women currently using hormone replacement therapy, with uncontrolled diabetes or other severe medical conditions, with a current DSM-5 psychiatric diagnosis, who have had surgical menopause, or who cannot attend visits at the Beirut center are unlikely to be eligible or to receive benefit from participation.
Why it matters
Potential benefit: If successful, intermittent fasting could provide a non-drug option to reduce mood symptoms, improve sleep, and sharpen thinking for women in perimenopause.
How similar studies have performed: Some small studies in general adult populations suggest intermittent fasting can improve mood and cognition, but its effects specifically in perimenopausal women are largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants eligible in this study will be women between the ages of 45 and 55 who are in the perimenopausal stage as defined by the STRAW criteria and confirmed using the Menopausal Rating Scale (MRS). Exclusion Criteria: * Currently using hormone replacement therapy * Diagnosed with severe medical conditions that could interfere with fasting, including uncontrolled diabetes, heart disease, hypertension, cancer or kidney disease * Have a current formal mental health diagnosis as defined by the DSM-5, regardless of whether they are receiving medication or therapy * Experiencing any form of dementia * Have undergone surgical menopause, have premature ovarian failure, are currently undergoing chemotherapy or radiotherapy, or are ovarian cancer survivors * Are currently pregnant. undergoing treatment for endometriosis, have significant thyroid disorders, or are on any form of hormone therapy * Do not speak English * Participants who score greater than 0 on question 9 of the PHQ-9 (including suicidal ideation) will be removed from the trial and provided with mental health referrals to NGOs for support.
Where this trial is running
Beirut
- American University of Beirut Medical Center — Beirut, Lebanon (Recruiting)
Study contacts
- Principal investigator: Nadia T Dandan, PsyD — American University of Beirut Medical Center
- Study coordinator: Nadia T Dandan, PsyD
- Email: nd55@aub.edu.lb
- Phone: +9613795428
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.