Time-restricted eating for women in menopause
Official title: Time-restricted Eating as a Dietary Intervention for Dyslipidemia in Peri- and Postmenopausal Women
Run by Brigham and Women's Hospital · NCT06188598 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if an 8-hour eating schedule can help improve cholesterol levels and body health in women going through menopause who have high cholesterol.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 58 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06188598 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy women aged 40-58 who are perimenopausal or recently postmenopausal with a BMI over 30 and untreated dyslipidemia.
✕Probably not a fit
Patients with eating disorders, serious mental health issues, or those on lipid-altering medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of an 8-hour time-restricted eating (TRE) intervention on lipid levels and body composition in peri- and recently postmenopausal women with untreated dyslipidemia. Participants will be randomly assigned to either the TRE group or a control group with unrestricted eating for 8 weeks after a 1-week baseline assessment. Throughout the study, various health metrics including fasting lipids, body weight, and mood will be evaluated at baseline and at the end of the intervention. The goal is to determine if TRE can improve metabolic health in this specific population.
Why it matters
Potential benefit: If successful, this intervention could lead to improved lipid profiles and body composition for peri- and postmenopausal women, potentially reducing cardiovascular risk.
How similar studies have gone: Other studies have shown promising results with time-restricted eating, suggesting potential benefits for metabolic health, although this specific approach in the target population is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy women aged 40-58 years * Perimenopausal or recently postmenopausal, \>1 year and \<5 years * BMI \> 30 kg/m2 * Dyslipidemic, defined as the presence of one or more lipid-based cardiovascular disease risk-enhancing factors per American College of Cardiology/American Heart Association guidelines * Normal renal and hepatic function * Perimenopausal women, a negative pregnancy test Exclusion Criteria: Dietary factors: * Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder * Concurrent dietary intervention or modification unrelated to study procedures Psychiatric factors: * Current major depressive episode * Suicidal ideation * Lifetime history of bipolar disorder, psychosis, or other serious mental health problem * Current alcohol/substance use disorder Medical factors: * Use of lipid-lowering or lipid-enhancing medications * Use of systemic hormonal (estrogens and/or progestin) therapies * Use of weight loss medications or supplements * Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months * Previous weight loss surgery * Abnormal vital signs at screening visit * Body weight \> 350 pounds, per DXA scan limits * Malignancy within past 2 years * Major surgery within past 3 months * Medical instability considered to interfere with study procedures * Contraindications to DXA scanning * Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas) * Undergoing treatment for cancer * Use of medications for which time-restricted eating would interfere with recommended timing of medication ingestion with food intake. Lifestyle and other factors: * Irregular sleep/wake schedule * Shiftwork * Recent travel across 2 or more time zones * Recent change in exercise habits * Work or social schedules that would impede ability to adhere to study protocol Adherence factors: -Inability to adhere to study procedures completed between screening and randomization visits Off-Study Criteria: * Initiation of new medications for lipid management, weight loss, hormonal medications, or other medications that may cause changes in weight or lipid levels * Development of any significant medical problem * Enrollment in another clinical trial involving study procedures or medications that might interfere with study procedures. * Significant deviation from study protocol or protocol violation * Inability to adhere to time-restricted eating window
Where it's running
-
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Leilah K Grant, PhD — Brigham and Women's Hospital
- Study coordinator: Leilah K Grant, PhD
- Email: lgrant@bwh.harvard.edu
- Phone: 6175257118
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Low-level laser acupuncture to improve body shape and composition in overweight menopausal women
This trial will test whether adding low-level multi-acupoint laser acupuncture to WHO-recommended diet and exercise helps overweight or obese menopausal women lose weight and improve body composition.
-
Integrated Traditional Chinese Medicine Program for Metabolic Syndrome
This study is testing a combined approach of Chinese herbal medicine and laser acupuncture to see if it can help people with metabolic syndrome improve their health over six months.
-
Culturally tailored diet intervention for adults in Puerto Rico
This study is testing a special diet plan designed for adults in Puerto Rico to see if it can help reduce heart and diabetes risks over two years.
-
Understanding chronic kidney disease in Sub-Saharan Africa
This study is trying to understand how common chronic kidney disease is in Sub-Saharan Africa and what factors might be causing it by looking at the health and lifestyle of adults in the Bagamoyo district.
-
Observational study on bariatric surgery outcomes
This study looks at how bariatric surgery affects weight loss and related health issues like diabetes in patients over two years after their surgery.
-
Understanding health trends in Puerto Rico
This study is trying to understand health trends in Puerto Rico by looking at diet, mental health, and heart health in adults aged 30-75 over time.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.