Intermittent Fasting, Mental Health, Perimenopause
Conditions
Keywords
Intermittent Fasting, Mental Health, Perimenopause, Depression
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.
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
BEHAVIORALIntermittent 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
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Intermittent Fasting on Depression Score Changes at 3 months | 3 months post-intervention start | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Baseline and at 3-month follow-up | 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. |
| Body Weight | baseline and at 3-month follow-up | 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. |
| Height | Baseline and at 3-month follow-up | 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. |
| Sleep Quality | Baseline and at 3-month follow-up | 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. |
| Cognitive Performance | Baseline and at 3-month follow-up | 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. |
| Menopausal Symptoms | Baseline and at 3-month follow-up | 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. |
| Sexual Health | Baseline and at 3-month follow-up | 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. |
| Body Image Satisfaction | Baseline and at 3-month follow-up | 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. |
Countries
Lebanon
Contacts
CONTACTNadia T Dandan, PsyD
CONTACTSara El Hajj, BA
PRINCIPAL_INVESTIGATORNadia T Dandan, PsyD
American University of Beirut Medical Center
Outcome results
None listed