Mental HealthNCT07481513
Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women
A study testing Intermittent fasting (16/8) in people with Mental Health and Perimenopause, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Perimenopause, Intermittent Fasting
- What is being tested?
- Intermittent fasting (16/8)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteLebanon
- Study dates
- 23 Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut
Nadia T Dandan, PsyD, +9613795428, nd55@aub.edu.lb
Sara El Hajj, BA, +96181727230, se148@aub.edu.lb
About this study
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.
Read the 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.
- Conditions
- Mental Health, Perimenopause, Intermittent Fasting
- Being tested
- Intermittent fasting (16/8)
- Keywords
- Intermittent Fasting, Mental Health, Perimenopause, Depression
- Medical subject headings
- Psychological Well-Being, Intermittent Fasting, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fasting (16/8)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-intervention start
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and at 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start23 Sep 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Tina Dandan, American University of Beirut Medical Center
- Investigators
- Nadia T Dandan, PsyD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481513
- Sponsor's protocol ID
- SBS-2024-0499
- Other IDs
- MPP
- Status last verified
- Aug 2025
- First submitted
- 20 Nov 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34513605Stapel 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.
PubMed 35538177Berthelot 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.
PubMed 34836202Patterson 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.
PubMed 25857868
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women
- ClinicalTrials.gov ID
- NCT07481513
- Acronym / sponsor ID
- SBS-2024-0499
- Conditions
- Mental Health, Perimenopause, Intermittent Fasting
- Keywords
- Intermittent Fasting, Mental Health, Perimenopause, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Intermittent fasting (16/8)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. |
| Control Group | No intervention | –The control group will receive food-based dietary guidelines for Lebanese adults, which will be explained by the research assistant |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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 | Behavioural | Experimental Group |
Primary outcome
Effect of Intermittent Fasting on Depression Score Changes at 3 months
Time frame: 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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 34513605Conde 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.
- Background: PubMed 35538177Stapel 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.
- Background: PubMed 34836202Berthelot 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.
- Background: PubMed 25857868Patterson 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.
- 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.Link provided by the sponsor.
- Fasting may improve core depressive symptoms in severe MDD via metabolic shifts, without worsening overall depression, supporting its role as antidepressant adjunct.Link provided by the sponsor.
- 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).Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadia T Dandan, PsyD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent fasting (16/8) in people with Mental Health and Perimenopause, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadia T Dandan, PsyD (+9613795428, nd55@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Intermittent Fasting on Depression Score Changes at 3 months (time frame: 3 months post-intervention start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07481513, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.