Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Julie Pendergast
Study ID
NCT04893226
Status
Recruiting
Apply to this trial

Conditions

  • Metabolic Syndrome
  • Postmenopausal Symptoms

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Time-Restricted Feeding (TRF) — 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.

Study Details

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.

Key Dates

Start date
Oct 19, 2021
Status verified
Nov 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536
Matt Thomas, PhD
[email protected]
(859) 218-6770

Find similar trials in Lexington, KY

By research site
University of Kentucky· Lexington, KY

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