Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women

NCT07481513 | Recruiting DMC

• 2 other identifiers: SBS-2024-0499MPP
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health; Perimenopause; Intermittent Fasting

Keywords

Intermittent Fasting; Mental Health; Perimenopause; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

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.

Behavioral: Intermittent fasting (16/8)

Control Group

NO INTERVENTION

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

Interventions

Intermittent fasting (16/8) BEHAVIORAL

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

Experimental Group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: Female only - only individuals who are identified as females and are in the perimenopausal stage are eligible to participate in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

RECRUITING

Related Publications (4)

• 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.

  PMID: 34513605 BACKGROUND

• 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.

  PMID: 35538177 BACKGROUND

• 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.

  PMID: 34836202 BACKGROUND

• 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.

  PMID: 25857868 BACKGROUND

Related 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.

MeSH Terms

Conditions

Psychological Well-Being; Intermittent Fasting; Depression

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Fasting; Feeding Behavior; Behavioral Symptoms

Study Officials

• Nadia T Dandan, PsyD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia T Dandan, PsyD

CONTACT

+9613795428; nd55@aub.edu.lb

Sara El Hajj, BA

CONTACT

+96181727230; se148@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: March 19, 2026
• Study Start: September 23, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)