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Clinical Trials/NCT07481513
NCT07481513RecruitingNot Applicable

Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women

American University of Beirut Medical Center1 site in 1 country140 target enrollmentStarted: September 23, 2025Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
140
Locations
1
Primary Endpoint
Effect of Intermittent Fasting on Depression Score Changes at 3 months

Study Overview

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.

Detailed Description

This study explores whether intermittent fasting (IF) can improve psychological well-being during a critical life stage. Intermittent fasting, particularly the popular 16/8 method, fasting for 16 hours and eating during an 8-hour window, has gained attention for its potential health benefits, including better metabolic function, hormonal balance, and cognitive performance. However, the impact on mental health among women in perimenopause remains largely unexplored. Perimenopause, which typically occurs between ages of 45 and 55, is a transitional phase marked by hormonal fluctuations that can cause mood changes, depression, anxiety, cognitive fog, poor sleep, and physical discomfort. While hormone replacement therapy (HRT) is a common solution, many women seek non-pharmacological alternatives due to concerns about side effects. This six-month randomized controlled trial aims to fill that gap by assessing whether intermittent fasting can positively influence mental health outcomes compared to standard dietary guidelines. The research will be conducted at the American University of Beirut Medical Center (AUBMC) and will involve 98 women in perimenopause, with up to 140 recruited to account for potential dropouts. Participants will be randomly assigned to either the experimental group, which will follow a 16/8 intermittent fasting regimen, or the control group, which will follow the Lebanese food-based dietary guidelines. Mental health will be assessed through validated measures such as the PHQ-9 for depression, GAD-7 for anxiety, and the Pittsburgh Sleep Quality Index for sleep quality, alongside assessments of body satisfaction, cognitive function, sexual health, and BMI. Data will be collected at baseline and follow-up intervals at 6,12, and 24 weeks. Women in the fasting group will receive guidance on the 16/8 schedule and weekly calls to encourage adherence and monitor side effects such as fatigue or low blood sugar. Any participant showing signs of severe distress or health issues will be referred for free medical or mental health support and withdrawn from the study if necessary. By focusing on mental health during perimenopause, this research seeks to provide a safe, cost-effective alternative to medication, potentially helping women manage symptoms and improve quality.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
45 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Experimental Group

Experimental

The experimental group will receive instructions on following a 16/8 intermittent fasting regimen, which involves fasting for 16 hours and consuming all meals within an 8-hour window. Participants in this group will also be asked to track their fasting routines using a designated schedule.

Intervention: Intermittent fasting (16/8) (Behavioral)

Control Group

No Intervention

The control group will receive food-based dietary guidelines for Lebanese adults, which will be explained by the research assistant

Outcomes

Primary Outcomes

Effect of Intermittent Fasting on Depression Score Changes at 3 months

Time Frame: 3 months post-intervention start

Change in depressive symptoms measured by the Patient Health Questionnaire-9 score from baseline to 3 months following the 16/8 intermittent fasting intervention. Depressive symptoms will be assessed at baseline and at the 3-month follow-up using the PHQ-9. Higher scores indicate greater depressive symptom severity.

Secondary Outcomes

  • Anxiety(Baseline and at 3-month follow-up)
  • Body Weight(baseline and at 3-month follow-up)
  • Height(Baseline and at 3-month follow-up)
  • Sleep Quality(Baseline and at 3-month follow-up)
  • Cognitive Performance(Baseline and at 3-month follow-up)
  • Menopausal Symptoms(Baseline and at 3-month follow-up)
  • Sexual Health(Baseline and at 3-month follow-up)
  • Body Image Satisfaction(Baseline and at 3-month follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nadia Tina Dandan

Clinical Instructor

American University of Beirut Medical Center

Study Sites (1)

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