Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women

Overview

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.

Interventions

• 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

Primary outcome measures

• Effect of Intermittent Fasting on Depression Score Changes at 3 months [Time frame: 3 months post-intervention start]

Secondary outcome measures (8)

• Anxiety [Time frame: Baseline and at 3-month follow-up]
• Body Weight [Time frame: baseline and at 3-month follow-up]
• Height [Time frame: Baseline and at 3-month follow-up]
• Sleep Quality [Time frame: Baseline and at 3-month follow-up]
• Cognitive Performance [Time frame: Baseline and at 3-month follow-up]
• Menopausal Symptoms [Time frame: Baseline and at 3-month follow-up]
• Sexual Health [Time frame: Baseline and at 3-month follow-up]
• Body Image Satisfaction [Time frame: Baseline and at 3-month follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Lebanon · 1 center

• American University of Beirut Medical Center — Beirut

Publications

• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07481513 · SBS-2024-0499 · MPP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗