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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-restricted eating (TRE) | Experimental | 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. |
|
| Unrestricted eating | No Intervention | Participants are instructed to continue their diet as normal without changing the type, amount or timing of food typically consumed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-restricted eating | Behavioral | Eating is restricted to an 8-hour window that is the same each day (e.g., 10am - 6pm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting triglyceride levels | Pre- to post-intervention change in fasting triglyceride levels (mg/dL) | 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 | Baseline (week 0) and post-intervention (week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Pre- to post-intervention change in body weight (kg) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time-course of triglyceride levels across 8 weeks | The time course of triglyceride (mg/dL) levels measured pre- mid- and post-intervention | Baseline (week 0), mid- (week 4) and post-intervention (week 8) |
Inclusion Criteria:
Exclusion Criteria:
Dietary factors:
Psychiatric factors:
Medical factors:
Lifestyle and other factors:
Adherence factors:
-Inability to adhere to study procedures completed between screening and randomization visits
Off-Study Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leilah K Grant, PhD | Contact | 6175257118 | lgrant@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Leilah K Grant, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 1, 2026 | |
| Reset | May 27, 2026 | |
| Release | Jun 3, 2026 | |
| Reset | Jun 25, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 1, 2026 | May 27, 2026 | |||
| Jun 3, 2026 |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
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Randomized on 1:1 bases to time-restricted eating or unrestricted eating
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Blood tests and assays, DXA scans, body weight, vitals, etc. are performed by assessors blinded to the condition and aims of the study.
| 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) | Baseline (week 0) and post-intervention (week 8) |
| Change in systolic blood pressure | Pre- to post-intervention change in systolic blood pressure (mmHg) | 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. | Baseline (week 0) and post-intervention (week 8) |
| 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. | 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. | 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 | 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. | Assessed daily over 1 week at baseline (week 0) and post-intervention (week 8) |
| Jun 25, 2026 |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |