Time-restricted Eating in Peri- and Postmenopausal Women

NCT06188598 | Unknown

• 1 other identifier: 2022P002288
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemias; Obesity; Menopause

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Change in body weight

  Baseline (week 0) and post-intervention (week 8)

• Change in high-density lipoprotein cholesterol (HDL-C)

  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 systolic blood pressure

  Baseline (week 0) and post-intervention (week 8)

• Change in sleep quality

  Baseline (week 0) and post-intervention (week 8)

Other Outcomes (1)

• Time-course of triglyceride levels across 8 weeks

  Baseline (week 0), mid- (week 4) and post-intervention (week 8)

Study Arms (2)

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.

Behavioral: Time-restricted eating

Unrestricted eating

NO INTERVENTION

Participants are instructed to continue their diet as normal without changing the type, amount or timing of food typically consumed.

Interventions

Time-restricted eating BEHAVIORAL

Eating is restricted to an 8-hour window that is the same each day (e.g., 10am - 6pm)

Time-restricted eating (TRE)

Eligibility Criteria

• Age: 40 Years - 58 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Dyslipidemias; Obesity

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Leilah K Grant, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leilah K Grant, PhD

CONTACT

6175257118; lgrant@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blood tests and assays, DXA scans, body weight, vitals, etc. are performed by assessors blinded to the condition and aims of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, Instructor in Medicine

Model Details: Randomized on 1:1 bases to time-restricted eating or unrestricted eating

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: December 21, 2022
• Primary Completion: December 21, 2024
• Study Completion: December 21, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)