Time-restricted Eating in Peri- and Postmenopausal Women
- Conditions
- ObesityDyslipidemiasMenopause
- Interventions
- Behavioral: Time-restricted eating
- Registration Number
- NCT06188598
- Lead Sponsor
- Brigham and Women's Hospital
- 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 untreated dyslipidemia.
- 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 women with untreated dyslipidemia. Following a 1-week baseline assessment, participants will be randomized to either a TRE or unrestricted control diet schedule (1-to-1 ratio) for 8 weeks. At baseline and weeks 4 and 8 of the intervention, daily eating and sleep patterns will be assessed for one week, followed by collection of fasting lipids and metabolic labs, body weight and vital signs; questionnaires assessing sleep and mood health, actigraphy and body composition via whole-body dual-energy x-ray absorptiometry will be assessed at baseline and week 8.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Time-restricted eating (TRE) Time-restricted eating Participants in the TRE group are instructed to restrict eating to an 8-hr window but were not asked to change the type or amount of food typically consumed. The 8-hour window (e.g., 10am - 6pm) has to be the same each day starting at least 2 hours after wake and ending at least 2 hours before bed.
- Primary Outcome Measures
Name Time Method Change in fasting triglyceride levels Baseline (week 0) and post-intervention (week 8) Pre- to post-intervention change in fasting triglyceride levels (mg/dL)
Change in visceral adiposity Baseline (week 0) and post-intervention (week 8) Pre- to post-intervention change in visceral adiposity (mass) as measured by dual energy x-ray absorptiometry scan
- Secondary Outcome Measures
Name Time Method Change in high-density lipoprotein cholesterol (HDL-C) Baseline (week 0) and post-intervention (week 8) Pre- to post-intervention change in HDL-C (mg/dL)
Change in depressive symptoms Baseline (week 0) and post-intervention (week 8) Change in depressive symptoms as measure by the Patient Health Questionnaire-8 (PHQ-8). The PHQ-8 score ranges from 0-24 with higher scores indicating greater depressive symptoms.
Change in low-density lipoprotein cholesterol (LDL-C) Baseline (week 0) and post-intervention (week 8) Pre- to post-intervention change in LDL-C (mg/dL)
Change in sleep duration Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8) Change in sleep duration based on the average of self-reported sleep duration over 1 week
Change in sleep efficiency Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8) Change in sleep efficiency based on the average of self-reported sleep efficiency over 1 week. Sleep efficiency to be calculated as total sleep time/ time in bed.
Change in systolic blood pressure Baseline (week 0) and post-intervention (week 8) Pre- to post-intervention change in systolic blood pressure (mmHg)
Change in sleep quality Baseline (week 0) and post-intervention (week 8) Change in sleep quality as measure by the Pittsburgh Sleep Quality Index (PSQI) global score. PSQI global score range is 0-21 with higher scores indicating more sleep disturbance.
Change in positive and negative affect Baseline (week 0) and post-intervention (week 8) Change in positive and negative affect as measure by the Positive and Negative Affect Schedule. The PANAS Positive and Negative scores range from 10-50 with higher scores indicating greater postive and negative affect, respectively.
Change in body weight Baseline (week 0) and post-intervention (week 8) Pre- to post-intervention change in body weight (kg)
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States