Time-restricted eating for women in menopause

Time-restricted Eating as a Dietary Intervention for Dyslipidemia in Peri- and Postmenopausal Women

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

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 40 Years to 58 Years
• Sex: Female
• Sponsor: Brigham and Women's Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06188598 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy women aged 40-58 who are perimenopausal or recently postmenopausal with a BMI over 30 and untreated dyslipidemia.

Not a fit: Patients with eating disorders, serious mental health issues, or those on lipid-altering medications may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Boston, Massachusetts

• 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

Conditions: Dyslipidemias, Obesity, Menopause