Status:
RECRUITING
Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women
Lead Sponsor:
Julie Pendergast
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Metabolic Syndrome
Postmenopausal Symptoms
Eligibility:
FEMALE
45-65 years
Phase:
NA
Brief 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 disruptio...
Detailed Description
This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding (TRF) on metabolic risk in postmenopausal women. Data will be collected for 18 weeks. Base...
Eligibility Criteria
Inclusion
- postmenopausal women
- age 45-65 years
- prediabetic or have at least 2 features of metabolic syndrome
Exclusion
- 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
Key Trial Info
Start Date :
October 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04893226
Start Date
October 19 2021
End Date
January 31 2027
Last Update
November 19 2025
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536