Time-restricted Eating in Peri- and Postmenopausal Women

NCT ID: NCT06188598

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-21
• Study Completion Date: 2024-12-21

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.

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.

Conditions

Dyslipidemias; Obesity; Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Time-restricted eating

Intervention Type: BEHAVIORAL

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

Unrestricted eating

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Time-restricted eating

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 58 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Leilah Kristine Grant

Investigator, Instructor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leilah K Grant, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Leilah K Grant, PhD

Role: CONTACT

lgrant@bwh.harvard.edu

6175257118

Facility Contacts

Leilah K Grant, PhD

Role: primary

lgrant@bwh.harvard.edu

617-525-7118

Other Identifiers

2022P002288

Identifier Type: -

Identifier Source: org_study_id