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

Inclusion Criteria1

  • 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 Criteria8

  • 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.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07481513


Related Trials