Time-Restricted Feeding (TRF) for Metabolic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Kentucky, Lexington, KYMetabolic Syndrome+1 MoreTime-Restricted Feeding (TRF) - Behavioral
Eligibility
45 - 65
Female
What conditions do you have?
Select

Study Summary

This trial will study whether time-restricted eating can improve metabolic health in postmenopausal women.

Eligible Conditions
  • Metabolic Syndrome
  • Postmenopausal Syndrome

Treatment Effectiveness

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: 18 weeks (baseline and post-intervention)

Week 18
Change in Body Mass Index
Change in C-Reactive Protein
Change in Hemoglobin A1c
Change in Insulin Sensitivity
Change in Mid-sleep
Change in Sleep Fragmentation Index
Change in Triglycerides

Trial Safety

Trial Design

2 Treatment Groups

Control
1 of 2
Time-Restricted Feeding (TRF) Group
1 of 2

Active Control

Experimental Treatment

164 Total Participants · 2 Treatment Groups

Primary Treatment: Time-Restricted Feeding (TRF) · No Placebo Group · N/A

Time-Restricted Feeding (TRF) Group
Behavioral
Experimental Group · 1 Intervention: Time-Restricted Feeding (TRF) · Intervention Types: Behavioral
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18 weeks (baseline and post-intervention)

Who is running the clinical trial?

Julie PendergastLead Sponsor
1 Previous Clinical Trials
67 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,186 Previous Clinical Trials
4,089,725 Total Patients Enrolled
34 Trials studying Metabolic Syndrome
2,758 Patients Enrolled for Metabolic Syndrome
Julie S Pendergast, PhDPrincipal InvestigatorUniversity of Kentucky

Eligibility Criteria

Age 45 - 65 · Female Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Women who have completed menopause.
You do not engage in regular physical activity or exercise.
You have early signs of developing diabetes or at least 2 symptoms of metabolic syndrome.

Frequently Asked Questions

Who has been approved to participate in this medical experiment?

"Patients with metabolic syndrome, aged between 45 and 65 years old, who fulfill the following criteria - sedentary lifestyle, prediabetes or having at least two features of metabolic syndrome (if applicable postmenopausal women) will be accepted into this clinical trial totalling 164 participants." - Anonymous Online Contributor

Unverified Answer

Is this trial actively searching for new participants?

"Affirmative. According to data posted on clinicaltrials.gov, this medical trial is actively accepting participants and was first made available online on October 19th 2021. 164 volunteers are needed from a single test site for the study's completion." - Anonymous Online Contributor

Unverified Answer

Is this investigation recruiting participants aged 30 and over?

"This medical trial seeks patients who are between the ages of 45 and 65. Separately, there are 10 studies dedicated to minors and 111 for those surpassing retirement age." - Anonymous Online Contributor

Unverified Answer

What key insights are investigators hoping to gain from this clinical experiment?

"The main focus of this 18-week experiment is to observe shifts in Triglyceride levels. Secondary indices, such as Sleep Fragmentation Index (as measured by actigraphy), Hemoglobin A1c content, and C-Reactive Protein concentrations will also be closely monitored." - Anonymous Online Contributor

Unverified Answer

What is the maximum participant capacity for this experiment?

"Affirmative. The information published on clinicaltrials.gov reveals that this medical study is currently recruiting participants, with the original posting date being October 19th 2021 and most recent update recorded as November 15th 2022. 164 patients are needed to be enrolled from a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.