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Recruiting NCT07481513

Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women

◆ AI Clinical Summary

This study examines whether intermittent fasting (eating within an 8-hour window daily) can improve mental health in women aged 45-55 going through perimenopause. The research focuses on how this eating pattern might help with mood and emotional well-being during a time when hormonal changes often affect mental health.

Key Objective: The trial tests whether intermittent fasting can reduce depression, anxiety, and mood disturbances in perimenopausal women.

Who to Consider: Women aged 45-55 experiencing perimenopause who are interested in exploring whether intermittent fasting might improve their mental health symptoms should consider enrolling.

Trial Parameters

Condition Mental Health
Sponsor American University of Beirut Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 140
Sex FEMALE
Min Age 45 Years
Max Age 55 Years
Start Date 2025-09-23
Completion 2026-06
Interventions
Intermittent fasting (16/8)

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

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