Status:
RECRUITING
Time-restricted Eating in Peri- and Postmenopausal Women
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Dyslipidemias
Obesity
Eligibility:
FEMALE
40-58 years
Phase:
NA
Brief Summary
The overall objective of the study is to examine the effect of an 8-hour time-restricted eating intervention on lipid levels and body composition in peri- and recently postmenopausal women with untrea...
Detailed Description
This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to ad libitum eating (control) on metabolic health and body composition in recently postmenopausal wom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 21 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06188598
Start Date
December 21 2022
End Date
December 21 2024
Last Update
January 5 2024
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115