Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

NCT ID: NCT04893226

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-19
• Study Completion Date: 2027-01-31

Brief Summary

This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.

Detailed Description

This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding (TRF) on metabolic risk in postmenopausal women. Data will be collected for 18 weeks. Baseline food timing, activity/sleep, and metabolic parameter (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers) data will be collected in the first two weeks (baseline). Subjects will then be randomized to the TRF intervention or no TRF for 16 weeks. Subjects in the TRF group will be educated about the health benefits of TRF. Then each subject in the TRF group will self-select a 10-h window and consume all daily calories during this time frame. Subjects in both the TRF and no TRF groups will text the time of their first and last daily meals for the duration of the study. At the end of the 16-week TRF intervention or no TRF, metabolic and anthropometric measurements will be collected.

Conditions

Metabolic Syndrome; Postmenopausal Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). There will be no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Time-Restricted Feeding (TRF) Group

Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). Subjects in this group will be educated about the health benefits of time-restricted feeding (TRF). Then each subject in the TRF group will self-select a 10-h window during which she will consume all daily calories for 16 weeks.

Group Type: EXPERIMENTAL

Time-Restricted Feeding (TRF)

Intervention Type: BEHAVIORAL

Subjects will be educated about the health benefits of time-restricted feeding (TRF). Each subject in the TRF group will self-select a 10 hour (10h +/- 1hr) window aligned with their active phase during which they will consume all daily calories. Subjects will text the time of their first and last daily meals for the duration of the study.

Interventions

Time-Restricted Feeding (TRF)

Subjects will be educated about the health benefits of time-restricted feeding (TRF). Each subject in the TRF group will self-select a 10 hour (10h +/- 1hr) window aligned with their active phase during which they will consume all daily calories. Subjects will text the time of their first and last daily meals for the duration of the study.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• postmenopausal women
• age 45-65 years
• prediabetic or have at least 2 features of metabolic syndrome

Exclusion Criteria

• on hormone therapy
• diabetes
• heart disease
• alcohol consumption of >2 drinks per day
• significant circadian disruption
• having care-taking responsibilities that significantly affect sleep
• shift work or irregular lifestyle
• uncontrolled sleep apnea or other uncontrolled sleep disorder
• extreme early or late chronotypes
• significant psychiatric disorders
• taking ADHD medications
• diagnosed dysregulated eating behaviors
• smoking >5 cigarettes/day or 30 pack-year history
• participating in formal weight loss program
• not weight stable

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Julie Pendergast

OTHER

Sponsor Role: lead

Responsible Party

Julie Pendergast

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Julie S Pendergast, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matt Thomas, PhD

Role: CONTACT

jmthomg@uky.edu

(859) 218-6770

Facility Contacts

Matt Thomas, PhD

Role: primary

jmthomg@uky.edu

(859) 218-6770

Other Identifiers

1R01DK124774-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BIO-21-TRF

Identifier Type: -

Identifier Source: org_study_id