University of Kentucky
Lexington, Kentucky, 40536, United States
Location status: Recruiting
NCT Number: NCT04893226
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.
Interested in participating?
Request Info45 year–65 year
Female
Interventional
Not applicable
Lexington, Kentucky, 40536, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 18 weeks (baseline and post-intervention)
Matsuda index will be assessed by the oral glucose tolerance test (OGTT).
Time frame: 18 weeks (baseline and post-intervention)
Body mass index will be calculated from height and weight.
Time frame: 18 weeks (baseline and post-intervention)
Triglycerides will be measured from fasting blood
Time frame: 18 weeks (baseline and post-intervention)
HbA1c is a measure of the proportion of glycated hemoglobin in blood.
Time frame: 18 weeks (baseline and post-intervention)
CRP will be measured from blood samples.
Time frame: 18 weeks (baseline and post-intervention)
Mid-sleep is a single outcome calculated using both actigraphy and sleep log information.
Time frame: 18 weeks (baseline and post-intervention)
Sleep fragmentation index, a measure of sleep quality, will be assessed from actigraphy data.
Contact information is provided by the study sponsor or research team.
Julie Pendergast
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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