Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-55
SponsorAmerican University of Beirut Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Intermittent fasting (16/8)
BehavioralParticipants 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
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
3 months post-intervention startSecondary outcomes
1
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-up2
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-up3
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-up4
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-upSponsors and contacts
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Source ClinicalTrials.gov