An interventional study of Intermittent fasting (16/8) in Mental Health, Perimenopause and Intermittent Fasting, sponsored by American University of Beirut Medical Center. Recruiting at 1 site in Lebanon. Open to female participants aged 45 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by American University of Beirut Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
333 studies on the registry are indexed under Intermittent Fasting; 99 are open to participants now.
This study's planned enrollment of 140 is above the median of 50 across 320 interventional studies indexed under Intermittent Fasting.
Browse Intermittent Fasting studies →American University of Beirut Medical Center is the lead sponsor of 158 studies on the registry; 24 are open to participants now.
Compared within Intermittent Fasting, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychological Well-Being. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
The control group will receive food-based dietary guidelines for Lebanese adults, which will be explained by the research assistant
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
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.
Time frame: 3 months post-intervention start
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and at 3-month follow-up
PDFs hosted by the registry, ClinicalTrials.gov.
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