Circadian Rhythms in Postmenopausal Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorJulie Pendergast
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
postmenopausal women
age 45-65 years
prediabetic or have at least 2 features of metabolic syndrome
Disqualifiers
on hormone therapy
diabetes
heart disease
alcohol consumption of >2 drinks per day
Trial design
Design model
Parallel
Treatments tested in this trial
Time-Restricted Feeding (TRF)
BehavioralSubjects 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.
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Time-Restricted Feeding (TRF) GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Insulin Sensitivity
Matsuda index will be assessed by the oral glucose tolerance test (OGTT).
Time frame
18 weeks (baseline and post-intervention)2
Change in Body Mass Index
Body mass index will be calculated from height and weight.
Time frame
18 weeks (baseline and post-intervention)3
Change in Triglycerides
Triglycerides will be measured from fasting blood
Time frame
18 weeks (baseline and post-intervention)Secondary outcomes
1
Change in Hemoglobin A1c
HbA1c is a measure of the proportion of glycated hemoglobin in blood.
Time frame
18 weeks (baseline and post-intervention)2
Change in C-Reactive Protein
CRP will be measured from blood samples.
Time frame
18 weeks (baseline and post-intervention)3
Change in Mid-sleep
Mid-sleep is a single outcome calculated using both actigraphy and sleep log information.
Time frame
18 weeks (baseline and post-intervention)4
Change in Sleep Fragmentation Index
Sleep fragmentation index, a measure of sleep quality, will be assessed from actigraphy data.
Time frame
18 weeks (baseline and post-intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Julie Pendergast
Lead sponsor
University of Kentucky
Sponsor institution
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov