Actively Recruiting

Phase Not Applicable
Age: 45Years - 65Years
FEMALE
Healthy Volunteers
NCT04893226

Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Led by Julie Pendergast · Updated on 2025-11-19

164

Participants Needed

1

Research Sites

275 weeks

Total Duration

On this page

Sponsors

J

Julie Pendergast

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Who Can Participate

Age: 45Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenopausal women
  • Age between 45 and 65 years
  • Diagnosed with prediabetes or have at least two features of metabolic syndrome
Not Eligible

You will not qualify if you...

  • Currently on hormone therapy
  • Diagnosed diabetes
  • Heart disease
  • Consuming more than 2 alcoholic drinks per day
  • Significant circadian rhythm disruption
  • Care-taking responsibilities significantly affecting sleep
  • Shift work or irregular lifestyle
  • Uncontrolled sleep apnea or other uncontrolled sleep disorders
  • Extreme early or late chronotypes
  • Significant psychiatric disorders
  • Taking ADHD medications
  • Diagnosed dysregulated eating behaviors
  • Smoking more than 5 cigarettes per day or having 30 pack-year smoking history
  • Participating in a formal weight loss program
  • Not weight stable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Kentucky

Lexington, Kentucky, United States, 40536

Actively Recruiting

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Research Team

M

Matt Thomas, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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