RecruitingNot ApplicableNCT07481513

Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women


Sponsor

American University of Beirut Medical Center

Enrollment

140 participants

Start Date

Sep 23, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 45 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how intermittent fasting (periods of not eating) affects the mental health of women going through perimenopause — the transition period leading up to menopause. Hormonal changes during this time can significantly impact mood and wellbeing, and researchers want to see if changing eating patterns can help. **You may be eligible if...** - You are a woman aged 45–55 who is in the perimenopausal stage (transitioning toward menopause, as confirmed by standard criteria) **You may NOT be eligible if...** - You are currently using hormone replacement therapy - You have serious health conditions such as uncontrolled diabetes, heart disease, high blood pressure, cancer, or kidney disease - You have a current formal mental health diagnosis (e.g., depression, anxiety disorder) - You are experiencing dementia - You have had surgical menopause, premature ovarian failure, or are undergoing cancer treatment - You have significant thyroid problems or are on any hormone therapy - You are pregnant - You have any thoughts of self-harm (as assessed by a screening question) - You do not speak English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIntermittent fasting (16/8)

Participants assigned to the experimental group will follow a 16/8 intermittent fasting regimen, which involves fasting for 16 consecutive hours each day and consuming all meals within an 8-hour eating window. This dietary approach distinguishes this intervention from others by focusing specifically on time-restricted eating, rather than simply caloric intake or meal composition. To support adherence and monitor consistency, participants will be provided with a fasting tracker sheet. This sheet will allow them to log fasting hours and eating windows, track their fasting days, and monitor adherence trends over time. Additionally, participants in this group will receive a comprehensive educational brochure tailored to intermittent fasting. The brochure includes: * Nutritional guidance on what types of food is recommended during the 8-hour eating window. * Tips to manage common side effects of fasting (e.g., fatigue, dizziness, low blood sugar). * General lifestyle tips for fasting


Locations(1)

American University of Beirut Medical Center

Beirut, Lebanon

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NCT07481513


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