RECRUITING

Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Quick Facts

Study Start:2021-10-19
Study Completion:2027-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04893226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * postmenopausal women
  2. * age 45-65 years
  3. * prediabetic or have at least 2 features of metabolic syndrome
  1. * on hormone therapy
  2. * diabetes
  3. * heart disease
  4. * alcohol consumption of \>2 drinks per day
  5. * significant circadian disruption
  6. * having care-taking responsibilities that significantly affect sleep
  7. * shift work or irregular lifestyle
  8. * uncontrolled sleep apnea or other uncontrolled sleep disorder
  9. * extreme early or late chronotypes
  10. * significant psychiatric disorders
  11. * taking ADHD medications
  12. * diagnosed dysregulated eating behaviors
  13. * smoking \>5 cigarettes/day or 30 pack-year history
  14. * participating in formal weight loss program
  15. * not weight stable

Contacts and Locations

Study Contact

Matt Thomas, PhD
CONTACT
(859) 218-6770
jmthomg@uky.edu

Principal Investigator

Julie S Pendergast, PhD
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40536
United States

Collaborators and Investigators

Sponsor: Julie Pendergast

  • Julie S Pendergast, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-19
Study Completion Date2027-01-31

Study Record Updates

Study Start Date2021-10-19
Study Completion Date2027-01-31

Terms related to this study

Keywords Provided by Researchers

  • postmenopause
  • weight
  • metabolic risk
  • glucose
  • body composition
  • lipid
  • sleep
  • prediabetes
  • fasting
  • circadian
  • inflammation

Additional Relevant MeSH Terms

  • Metabolic Syndrome
  • Postmenopausal Symptoms