Time-restricted Eating in Peri- and Postmenopausal Women

Time-restricted Eating as a Dietary Intervention for Dyslipidemia in Peri- and Postmenopausal Women

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Dyslipidemias; Menopause
• Intervention / Treatment: Behavioral: Time-restricted eating

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leilah K Grant, PhD; Phone Number: 6175257118; Email: lgrant@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Leilah K Grant, PhD; Phone Number: 617-525-7118; Email: lgrant@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time-restricted eating (TRE); 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.	Behavioral: Time-restricted eating; Eating is restricted to an 8-hour window that is the same each day (e.g., 10am - 6pm)
No Intervention: Unrestricted eating; Participants are instructed to continue their diet as normal without changing the type, amount or timing of food typically consumed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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 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)
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)

Other Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Leilah K Grant, PhD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2022
• Primary Completion (Estimated): December 21, 2024
• Study Completion (Estimated): December 21, 2024

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 2022P002288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No