Last updated: January 3, 2024
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes Prevention
Menopause
Obesity
Treatment
Time-restricted eating
Clinical Study ID
NCT06188598
2022P002288
Ages 40-58 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 cardiovasculardisease risk-enhancing factors per American College of Cardiology/American HeartAssociation guidelines
- Normal renal and hepatic function
- Perimenopausal women, a negative pregnancy test
Exclusion
Exclusion Criteria: Dietary factors:
- Diagnosis, or strong clinical suspicion, of eating disorders, including but notlimited 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 healthproblem
- 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 andmedication 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 recommendedtiming 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 randomizationvisits 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 thatmight interfere with study procedures.
- Significant deviation from study protocol or protocol violation
- Inability to adhere to time-restricted eating window
Study Design
Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Time-restricted eating
Phase:
Study Start date:
December 21, 2022
Estimated Completion Date:
December 21, 2024
Study Description
Connect with a study center
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
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