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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Eating is restricted to an 8-hour window that is the same each day (e.g., 10am - 6pm)
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGChange in fasting triglyceride levels
Pre- to post-intervention change in fasting triglyceride levels (mg/dL)
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in visceral adiposity
Pre- to post-intervention change in visceral adiposity (mass) as measured by dual energy x-ray absorptiometry scan
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in body weight
Pre- to post-intervention change in body weight (kg)
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in high-density lipoprotein cholesterol (HDL-C)
Pre- to post-intervention change in HDL-C (mg/dL)
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in low-density lipoprotein cholesterol (LDL-C)
Pre- to post-intervention change in LDL-C (mg/dL)
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in systolic blood pressure
Pre- to post-intervention change in systolic blood pressure (mmHg)
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in sleep quality
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.
Time frame: Baseline (week 0) and post-intervention (week 8)
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Change in depressive symptoms
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.
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in positive and negative affect
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.
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in sleep duration
Change in sleep duration based on the average of self-reported sleep duration over 1 week
Time frame: Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8)
Change in sleep efficiency
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.
Time frame: Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8)