Impact of Intermittent Fasting on the Mental Health of Perimenopausal Women
Recruiting · NCT07481513 · Interventional (participants receive a specific treatment) · Lead sponsor: American University of Beirut Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- American University of Beirut Medical Center - Beirut, Lebanon