Recruiting

Time-Restricted FeedingCircadian Rhythms in Postmenopausal Women

Sponsor:

Julie Pendergast

Code:

NCT04893226

Conditions

Metabolic Syndrome

Postmenopausal Symptoms

Eligibility Criteria

Sex: Female

Age: 45 - 65

Healthy Volunteers: Accepted

Interventions

Time-Restricted Feeding (TRF)

Study Details

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.

Conditions

Metabolic Syndrome

Postmenopausal Symptoms

Study ID

NCT04893226

Start date

Oct 19, 2021

Status verified date

Aug, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 45 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control

experimental: 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.

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.

Primary outcome measure

Change in Insulin Sensitivity [ Time Frame: 18 weeks (baseline and post-intervention) ]
Change in Body Mass Index [ Time Frame: 18 weeks (baseline and post-intervention) ]
Change in Triglycerides [ Time Frame: 18 weeks (baseline and post-intervention) ]

Central Contacts and Locations

Central contacts

Matt Thomas, PhD

(859) 218-6770 jmthomg@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Matt Thomas, PhD

(859) 218-6770 jmthomg@uky.edu

More Information

Sponsor

Julie Pendergast

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

postmenopause
weight
metabolic risk
glucose
body composition
lipid
sleep
prediabetes
fasting
circadian
inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Julie Pendergast on 2026-08-10.