Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women
2 other identifiers
interventional
164
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedStudy Start
First participant enrolled
October 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
November 19, 2025
November 1, 2025
5.3 years
May 12, 2021
November 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Change in Hemoglobin A1c
18 weeks (baseline and post-intervention)
Change in C-Reactive Protein
18 weeks (baseline and post-intervention)
Change in Mid-sleep
18 weeks (baseline and post-intervention)
Change in Sleep Fragmentation Index
18 weeks (baseline and post-intervention)
Study Arms (2)
Control
NO INTERVENTIONParticipants 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.
Time-Restricted Feeding (TRF) Group
EXPERIMENTALParticipants 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
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.
Eligibility Criteria
You may qualify if:
- postmenopausal women
- age 45-65 years
- prediabetic or have at least 2 features of metabolic syndrome
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40536, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie S Pendergast, PhD
University of Kentucky
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 12, 2021
First Posted
May 19, 2021
Study Start
October 19, 2021
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
November 19, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share