Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Health; Intermittent Fasting; Perimenopause
• Intervention / Treatment: Behavioral: Intermittent fasting (16/8)

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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadia T Dandan, PsyD; Phone Number: +9613795428; Email: nd55@aub.edu.lb
• Study Contact Backup: Name: Sara El Hajj, BA; Phone Number: +96181727230; Email: se148@aub.edu.lb

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • American University of Beirut Medical Center
    • Contact: Nadia T Dandan, PsyD; Phone Number: +9613795428; Email: nd55@aub.edu.lb
    • Contact: Sara El Hajj, BA; Phone Number: +96181727230; Email: se148@aub.edu.lb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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.	Behavioral: Intermittent 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
No Intervention: Control Group; The control group will receive food-based dietary guidelines for Lebanese adults, which will be explained by the research assistant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Intermittent Fasting on Depression Score Changes at 3 months	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.	3 months post-intervention start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Participants' anxiety symptoms will be assessed using the Generalized Anxiety Disorder 7-item Scale (GAD-7). The GAD-7 is a validated self-report questionnaire consisting of 7 items that measure the severity of generalized anxiety symptoms over the past two weeks. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity.	Baseline and at 3-month follow-up
Body Weight	Participants' height will be measured in kilograms using the InBody body composition analyzer. Measurements will be taken at baseline and at 3-month follow-up to assess changes over the course of the intervention.	baseline and at 3-month follow-up
Height	Participant height will be self-reported at the baseline visit. The reported height will be entered into the InBody device to allow calculation of Body Mass Index (BMI) based on the participant's height and measured weight.	Baseline and at 3-month follow-up
Sleep Quality	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated self-report questionnaire that evaluates sleep quality and disturbances over the past month across multiple components. The instrument generates a global score ranging from 0 to 21, with higher scores indicating poor sleep quality.	Baseline and at 3-month follow-up
Cognitive Performance	Cognitive Performance will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA is a standardized cognitive screening tool that evaluates multiple cognitive domains. The test produces a total score ranging from 0 to 30, with higher scores indicating better cognitive performance.	Baseline and at 3-month follow-up
Menopausal Symptoms	Menopausal symptoms will be assessed using the menopausal rating scale (MRS). The MRS is a validated self-report questionnaire to evaluate the severity of common menopausal symptoms across three domains. The scale generates a total score based on participants' responses, with higher scores indicating greater severity of menopausal symptoms.	Baseline and at 3-month follow-up
Sexual Health	Sexual Health will be assessed using the Female Sexual Function Index (FSFI). The FSFI is a validated self-reported questionnaire that evaluates key domains. The instrument generates a total score based on responses across these domains, with higher scores indicating better sexual functioning.	Baseline and at 3-month follow-up
Body Image Satisfaction	Body Satisfaction will be assessed using the Body Appreciation Scale -2 (BAS-2). The BAS-2 is a validated self-report questionnaire that measures positive body image and overall body appreciation. Higher scores indicate greater body appreciation and satisfaction with one's body.	Baseline and at 3-month follow-up

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Nadia T Dandan, PsyD, American University of Beirut Medical Center

Publications and helpful links

General Publications

• Patterson RE, Laughlin GA, LaCroix AZ, Hartman SJ, Natarajan L, Senger CM, Martinez ME, Villasenor A, Sears DD, Marinac CR, Gallo LC. Intermittent Fasting and Human Metabolic Health. J Acad Nutr Diet. 2015 Aug;115(8):1203-12. doi: 10.1016/j.jand.2015.02.018. Epub 2015 Apr 6. No abstract available.
• Berthelot E, Etchecopar-Etchart D, Thellier D, Lancon C, Boyer L, Fond G. Fasting Interventions for Stress, Anxiety and Depressive Symptoms: A Systematic Review and Meta-Analysis. Nutrients. 2021 Nov 5;13(11):3947. doi: 10.3390/nu13113947.
• Conde DM, Verdade RC, Valadares ALR, Mella LFB, Pedro AO, Costa-Paiva L. Menopause and cognitive impairment: A narrative review of current knowledge. World J Psychiatry. 2021 Aug 19;11(8):412-428. doi: 10.5498/wjp.v11.i8.412. eCollection 2021 Aug 19.
• Stapel B, Fraccarollo D, Westhoff-Bleck M, Bauersachs J, Lichtinghagen R, Jahn K, Burkert A, Buchholz V, Bleich S, Frieling H, Ding XQ, Kahl KG. Impact of fasting on stress systems and depressive symptoms in patients with major depressive disorder: a cross-sectional study. Sci Rep. 2022 May 10;12(1):7642. doi: 10.1038/s41598-022-11639-1.

Helpful Links

• This narrative review by Conde et al. synthesizes evidence on menopause-related cognitive decline, estrogen's neuroprotective effects, and hormone therapy's inconsistent benefits for cognition.
• Fasting may improve core depressive symptoms in severe MDD via metabolic shifts, without worsening overall depression, supporting its role as antidepressant adjunct.
• This systematic review and meta-analysis included 11 studies with 1436 participants focusing on RCTs with low bias risk for primary outcomes. It analyszed pre/post-Ramadan data and controlled fasting trials (time-restricted eating, caloric restriction).
• This narrative review analyzes human trials up to 2015 on IF's metabolic impacts, contrasting it with continous calorie restriction, without meta-analysis. It covers feasibility, weight loss, insulin sensitivity, lipid profiles, and cardio-protection.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Mental Health; Intermittent Fasting; Perimenopause
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Personal Satisfaction; Feeding Behavior; Fasting; Depression; Psychological Well-Being; Intermittent Fasting
• Other Study ID Numbers: SBS-2024-0499; MPP (Other Grant/Funding Number: AUBMC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No