NCT03504683

MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes

Recruiting now NA Last updated 10 March 2025

What this trial tests

NA trial testing Early TRE in PreDiabetes in 144 participants. Currently enrolling.

Timeline

17 August 2020

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	144
Start date	17 August 2020
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across United States

Drugs / interventions tested

• Early TRE
• Mid-day TRE
• Control Schedule

Conditions studied

• PreDiabetes — all drugs for PreDiabetes →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 30 to 70, any sex, with PreDiabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted eating; TRE) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRE also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRE can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRE depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRE' (eat between \~8 am-3 pm), (2) 'Mid-day TRE' (eat between \~1 pm - 8 pm), or (3) Control Schedule (\~8 am - 8 pm) for 8 weeks. All food will be provided and matched between groups.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Time-restricted Eating for the Prevention and Management of Metabolic Diseases.
   Manoogian ENC, Chow LS, Taub PR, Laferrère B, et al · · 2022 · cited 223× · PMID 34550357 · DOI 10.1210/endrev/bnab027
2. Time-restricted eating: Watching the clock to treat obesity.
   Ezpeleta M, Cienfuegos S, Lin S, Pavlou V, et al · · 2024 · cited 83× · PMID 38176412 · DOI 10.1016/j.cmet.2023.12.004
3. Intermittent fasting for the prevention of cardiovascular disease.
   Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, et al · · 2021 · cited 66× · PMID 33512717 · DOI 10.1002/14651858.cd013496.pub2