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Time-Restricted Feeding for Cardiovascular Disease Risk Factors

N/A
Recruiting
Led By Courtney M. Peterson, Ph.D.
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 30-65 years old
Prediabetic as determined by HbA1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

This trial will study whether time-restricted feeding, a form of intermittent fasting, can help improve blood sugar control, blood pressure, and cardiovascular disease risk factors.

Who is the study for?
This trial is for adults aged 30-65 with a BMI of 27-43 who regularly wake up between 5-8 am and are prediabetic. It's not suitable for those with psychiatric conditions, significant diseases, recent weight fluctuations, or on certain medications affecting glucose or blood pressure.Check my eligibility
What is being tested?
The study tests if eating within specific hours (Early TRF: ~8 am-3 pm; Mid-day TRF: ~1 pm - 8 pm) versus a control schedule (~8 am - 8 pm) affects blood sugar control, blood pressure, and cardiovascular risk factors over a period of 10 weeks.See study design
What are the potential side effects?
Since the intervention involves dietary changes rather than medication, side effects may include hunger outside of eating windows, potential temporary changes in energy levels or mood due to adjustment to new eating patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 30 and 65 years old.
Select...
My blood sugar levels indicate I am prediabetic.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Beta-cell responsivity index (a measure of beta-cell function)
C-Peptide
Glucose AUCs
+6 more
Secondary outcome measures
8-isoprostane
Cortisol
Daily maximum value, minimum value, and amplitude of systolic and diastolic blood pressure
+6 more
Other outcome measures
Body weight
Bone mineral density
Chronotype
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Mid-day Time-Restricted FeedingExperimental Treatment1 Intervention
Group II: Early Time-Restricted FeedingExperimental Treatment1 Intervention
Group III: Control SchedulePlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Early Time-Restricted Feeding
2018
N/A
~90

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,573 Previous Clinical Trials
2,273,133 Total Patients Enrolled
Courtney M. Peterson, Ph.D.Principal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

Control Schedule Clinical Trial Eligibility Overview. Trial Name: NCT03504683 — N/A
Prediabetes Research Study Groups: Early Time-Restricted Feeding, Mid-day Time-Restricted Feeding, Control Schedule
Prediabetes Clinical Trial 2023: Control Schedule Highlights & Side Effects. Trial Name: NCT03504683 — N/A
Control Schedule 2023 Treatment Timeline for Medical Study. Trial Name: NCT03504683 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there presently an opportunity to join this clinical experiment?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial has been recruiting participants, starting from August 17th 2020 and was last updated on April 15 2022. The study is accepting 144 patients for one centre of investigation."

Answered by AI

Does this research study admit individuals older than 25?

"The requirements for participation in this trial specify that patients must be aged 30 to 65. Currently, there are 41 trials open to those younger than 18 and 550 clinical studies available to individuals over the age of 65."

Answered by AI

Am I eligible to take part in this research endeavor?

"For this trial, 144 people with prediabetes between the ages of 30 and 65 are being recruited. Aspiring participants must also meet additional requirements including having a BMI within 27-43 kg/m^2 and regularly waking up between 5am to 8am."

Answered by AI

How many participants is the research team recruiting for this experiment?

"Affirmative. Clinicaltrials.gov records demonstrate that this research project, posted on August 17th 2020, is actively seeking participants. A total of 144 patients must be enrolled at one single clinic for the study to move forward."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~29 spots leftby Mar 2025