Intermittent fasting for mental health during perimenopause

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.