Clinical trial NCT04893226: Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women
Official title: Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Postmenopausal Symptoms
Keywords: postmenopause
weight
metabolic risk
glucose
body composition
lipid
sleep
prediabetes
fasting
circadian
inflammation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-05-19
Enrollment: 164
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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. 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.

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

Primary outcomes:
measure: Change in Insulin Sensitivity
timeFrame: 18 weeks (baseline and post-intervention)
measure: Change in Body Mass Index
timeFrame: 18 weeks (baseline and post-intervention)
measure: Change in Triglycerides
timeFrame: 18 weeks (baseline and post-intervention)
Secondary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: 18 weeks (baseline and post-intervention)
measure: Change in C-Reactive Protein
timeFrame: 18 weeks (baseline and post-intervention)
measure: Change in Mid-sleep
timeFrame: 18 weeks (baseline and post-intervention)
measure: Change in Sleep Fragmentation Index
timeFrame: 18 weeks (baseline and post-intervention)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Julie S Pendergast, PhD
role: PRINCIPAL_INVESTIGATOR
References: