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Search / Trial NCT04893226

Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Launched by JULIE PENDERGAST · May 17, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Postmenopause Weight Metabolic Risk Glucose Body Composition Lipid Sleep Prediabetes Fasting Circadian Inflammation

ClinConnect Summary

This clinical trial is looking at how time-restricted feeding—eating during specific hours of the day—can help improve health in postmenopausal women who have metabolic issues. Researchers believe that this eating pattern might help with problems like insulin sensitivity (how well your body uses sugar), glucose tolerance (how your body handles sugar), and weight management. The study is specifically focused on women aged 45 to 65 who are postmenopausal and have prediabetes or at least two signs of metabolic syndrome, which includes issues like high blood pressure or high cholesterol.

If you or someone you know fits this description, you might be eligible to participate in the trial. However, there are some important factors to consider; participants cannot be on hormone therapy, have diabetes, or significant heart disease. The study is currently recruiting participants, and those who join can expect guidance on the time-restricted eating regimen and regular monitoring of their health. This could be an opportunity to contribute to research that may help improve health for many women experiencing similar issues.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • postmenopausal women
  • age 45-65 years
  • prediabetic or have at least 2 features of metabolic syndrome
  • Exclusion Criteria:
  • 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

About Julie Pendergast

Julie Pendergast is a dedicated clinical trial sponsor with extensive experience in managing and overseeing clinical research initiatives. With a strong emphasis on patient safety and data integrity, she is committed to advancing medical knowledge through innovative trial designs and rigorous methodologies. Julie collaborates closely with research institutions and healthcare professionals to ensure compliance with regulatory standards while fostering an environment of ethical research practices. Her leadership in clinical trials aims to facilitate the development of effective therapies that address unmet medical needs, ultimately improving patient outcomes.

Locations

Lexington, Kentucky, United States

Patients applied

0 patients applied

Trial Officials

Julie S Pendergast, PhD

Principal Investigator

University of Kentucky

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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