Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome; Postmenopausal Symptoms
• Intervention / Treatment: Behavioral: Time-Restricted Feeding (TRF)

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.

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matt Thomas, PhD; Phone Number: (859) 218-6770; Email: jmthomg@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky
      • Contact: Matt Thomas, PhD; Phone Number: (859) 218-6770; Email: jmthomg@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Insulin Sensitivity	Matsuda index will be assessed by the oral glucose tolerance test (OGTT).	18 weeks (baseline and post-intervention)
Change in Body Mass Index	Body mass index will be calculated from height and weight.	18 weeks (baseline and post-intervention)
Change in Triglycerides	Triglycerides will be measured from fasting blood	18 weeks (baseline and post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c	HbA1c is a measure of the proportion of glycated hemoglobin in blood.	18 weeks (baseline and post-intervention)
Change in C-Reactive Protein	CRP will be measured from blood samples.	18 weeks (baseline and post-intervention)
Change in Mid-sleep	Mid-sleep is a single outcome calculated using both actigraphy and sleep log information.	18 weeks (baseline and post-intervention)
Change in Sleep Fragmentation Index	Sleep fragmentation index, a measure of sleep quality, will be assessed from actigraphy data.	18 weeks (baseline and post-intervention)

Collaborators and Investigators

• Sponsor: Julie Pendergast
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Julie S Pendergast, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: sleep; inflammation; body composition; circadian; metabolic risk; prediabetes; postmenopause; glucose; fasting; lipid; weight
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Insulin Resistance; Hyperinsulinism; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Feeding Behavior; Body Weight; Metabolic Syndrome; Inflammation; Prediabetic State; Fasting
• Other Study ID Numbers: BIO-21-TRF; 1R01DK124774-01A1 (U.S. NIH Grant/Contract)

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