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Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

NCT04893226 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2025-11-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

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

    collaborator NIH

  • Julie Pendergast

    lead OTHER

Principal Investigators

  • Julie S Pendergast, PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04893226 on ClinicalTrials.gov