Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04893226
Other study ID # BIO-21-TRF
Secondary ID 1R01DK124774-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date October 19, 2021
Est. completion date February 27, 2026

Study information

Verified date November 2023
Source University of Kentucky
Contact Matt Thomas, PhD
Phone (859) 218-6770
Email jmthomg@uky.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


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. Baseline food timing, activity/sleep, and metabolic parameter (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers) data will be collected in the first two weeks (baseline). Subjects will then be randomized to the TRF intervention or no TRF for 16 weeks. Subjects in the TRF group will be educated about the health benefits of TRF. Then each subject in the TRF group will self-select a 10-h window and consume all daily calories during this time frame. Subjects in both the TRF and no TRF groups will text the time of their first and last daily meals for the duration of the study. At the end of the 16-week TRF intervention or no TRF, metabolic and anthropometric measurements will be collected.


Recruitment information / eligibility

Status Recruiting
Enrollment 164
Est. completion date February 27, 2026
Est. primary completion date February 27, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 65 Years
Eligibility 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 sleep disorder - extreme early or late chronotypes - significant psychiatric disorders or ADHD - diagnosed dysregulated eating behaviors

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Time-Restricted Feeding (TRF)
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.

Locations

Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (2)

Lead Sponsor Collaborator
Julie Pendergast National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Insulin Sensitivity Matsuda index will be assessed by the oral glucose tolerance test (OGTT). 18 weeks (baseline and post-intervention)
Primary Change in Body Mass Index Body mass index will be calculated from height and weight. 18 weeks (baseline and post-intervention)
Primary Change in Triglycerides Triglycerides will be measured from fasting blood 18 weeks (baseline and post-intervention)
Secondary Change in Hemoglobin A1c HbA1c is a measure of the proportion of glycated hemoglobin in blood. 18 weeks (baseline and post-intervention)
Secondary Change in C-Reactive Protein CRP will be measured from blood samples. 18 weeks (baseline and post-intervention)
Secondary Change in Mid-sleep Mid-sleep is a single outcome calculated using both actigraphy and sleep log information. 18 weeks (baseline and post-intervention)
Secondary Change in Sleep Fragmentation Index Sleep fragmentation index, a measure of sleep quality, will be assessed from actigraphy data. 18 weeks (baseline and post-intervention)
See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04509206 - Virtual Teaching Kitchen N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A