NCT07481513 Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women
| NCT ID | NCT07481513 |
| Status | Recruiting |
| Phase | — |
| Sponsor | American University of Beirut Medical Center |
| Condition | Mental Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-09-23 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2025-09-23 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will explore how intermittent fasting (specifically the 16/8 method) affects the mental health of women who are in the perimenopause stage. This life stage often brings hormonal changes that can impact emotional and physical well-being. The study will include 98 women aged 45-55, who will be randomly divided into two groups. The study will compare the mental health outcomes of those who follow intermittent fasting with those who do not, using independent t-tests to analyze the results. The goal is to better understand if intermittent fasting can help improve mental health during perimenopause.
Eligibility 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.
Contact & Investigator
Nadia T Dandan, PsyD
PRINCIPAL INVESTIGATOR
American University of Beirut Medical Center
Frequently Asked Questions
Who can join the NCT07481513 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 55 Years, studying Mental Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07481513 currently recruiting?
Yes, NCT07481513 is actively recruiting participants. Contact the research team at nd55@aub.edu.lb for enrollment information.
Where is the NCT07481513 trial being conducted?
This trial is being conducted at Beirut, Lebanon.
Who is sponsoring the NCT07481513 clinical trial?
NCT07481513 is sponsored by American University of Beirut Medical Center. The principal investigator is Nadia T Dandan, PsyD at American University of Beirut Medical Center. The trial plans to enroll 140 participants.