Overview
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.
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.
Eligibility
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