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NCT03504683 · ClinicalTrials.gov registry record · NA

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

A NA study of PreDiabetes, sponsored by University of Alabama at Birmingham.

Recruiting
Registry status
NA
Development phase
144
Enrollment target
1
Study location

NCT03504683 is a NA study of PreDiabetes that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 144 participants, below the 689-participant average among 89 other PreDiabetes trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03504683, a NA study of PreDiabetes, is actively recruiting participants, sponsored by University of Alabama at Birmingham.

RECRUITING
Registry status
NA
Development phase
144 participants
Enrollment target
1
Study location

Study Summary

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.

Conditions Studied

PreDiabetes

Interventions

  • BEHAVIORAL Early TRE
  • BEHAVIORAL Mid-day TRE
  • BEHAVIORAL Control Schedule

Study Locations (1)

Alabama

  • University of Alabama at Birmingham - Birmingham

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2020-08-17
Est. Completion 2025-12-31
Phase NA

Sponsor

University of Alabama at Birmingham

1,160 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03504683

The ClinicalTrials.gov registry entry for NCT03504683 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 689-participant average among 89 other PreDiabetes trials with a reported enrollment target (79% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with PreDiabetes appearing as the primary indexed condition, and to 3 interventions - of which Early TRE is the first listed.

NCT03504683 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.

Frequently Asked Questions

What is clinical trial NCT03504683 about?

NCT03504683 is a clinical study titled "MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes". 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...

What is the current status of trial NCT03504683?

This trial is currently recruiting. It is a NA study. The enrollment target is 144 participants. The study started on 2020-08-17. Estimated completion is 2025-12-31.

What conditions does trial NCT03504683 study?

This clinical trial studies the following conditions: PreDiabetes.

What interventions are being tested in trial NCT03504683?

The interventions under investigation include: Early TRE (BEHAVIORAL), Mid-day TRE (BEHAVIORAL), Control Schedule (BEHAVIORAL).

Who is sponsoring clinical trial NCT03504683?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03504683 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.