Time-restricted Eating as a Dietary Intervention for Dyslipidemia in Peri- and Postmenopausal Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dyslipidemias
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in fasting triglyceride levels
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Leilah Kristine Grant
Investigator, Instructor in Medicine
Brigham and Women's Hospital
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
Outcomes
Primary Outcomes
Change in fasting triglyceride levels
Time Frame: Baseline (week 0) and post-intervention (week 8)
Pre- to post-intervention change in fasting triglyceride levels (mg/dL)
Change in visceral adiposity
Time Frame: 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 Outcomes
- Change in high-density lipoprotein cholesterol (HDL-C)(Baseline (week 0) and post-intervention (week 8))
- Change in depressive symptoms(Baseline (week 0) and post-intervention (week 8))
- Change in low-density lipoprotein cholesterol (LDL-C)(Baseline (week 0) and post-intervention (week 8))
- Change in sleep duration(Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8))
- Change in sleep efficiency(Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8))
- Change in systolic blood pressure(Baseline (week 0) and post-intervention (week 8))
- Change in sleep quality(Baseline (week 0) and post-intervention (week 8))
- Change in positive and negative affect(Baseline (week 0) and post-intervention (week 8))
- Change in body weight(Baseline (week 0) and post-intervention (week 8))