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

April 29, 2026 updated by: Courtney M Peterson, University of Alabama at Birmingham

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Courtney M. Peterson, Ph.D.
  • Phone Number: 205-934-0122
  • Email: cpeterso@uab.edu

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 30-70 years old
  • Prediabetic as determined by HbA1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl with HbA1c >= 5.1%
  • Fasting insulin less than 100.0 mU/l and, if HbA1c <5.7%, must also have fasting insulin >= 8.0 mU/l
  • BMI between 30-60 kg/m^2
  • Wake up at a regular time between 5-8 am

Exclusion Criteria:

  • Been diagnosed with diabetes or on diabetes medication or any medication known to affect glucose or 24-hour rhythms in blood pressure
  • On weight loss medication
  • Change in the dosage of a chronic medication within the past 2 months
  • Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
  • Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
  • Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity
  • Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
  • Pregnant or breastfeeding
  • Diagnosed psychiatric conditions
  • Sleep disorder, circadian disorder, or regularly sleep less than 6 hours per night
  • Major change in health or medical history in the past 3 months
  • Currently perform overnight shift work
  • Regularly eat within a <10.5-hour period each day
  • Lost or gained more than 4% of weight in the past 2 months
  • Traveled more than 2 time zones away in the 2 months prior to enrolling in this study
  • Will travel outside the Central time zone in the 2 weeks prior to testing
  • Will travel more than 1 time zone away during this study
  • Behavioral factors or other circumstances that may make it difficult for you to follow the study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control Schedule
Behavioral: Control Schedule
Eat between 8 am - 8 pm (or 7 am - 7 pm, if an early riser)
Experimental: Early TRE
Behavioral: Early TRE
Eat between 8 am - 3 pm (or 7 am - 2 pm, if an early riser)
Other Names:
  • eTRE
Experimental: Mid-day TRE
Behavioral: Mid-day TRE
Eat between 1 pm - 8 pm (or 12 pm - 7 pm, if an early riser)
Other Names:
  • mTRE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean 24-hour glucose levels
Time Frame: 8 weeks
Mean 24-hour glucose levels (mg/dl)
8 weeks
Mean 24-hour insulin levels
Time Frame: 8 weeks
Mean 24-hour insulin levels (mU/l)
8 weeks
Mean 24-hour C-peptide levels
Time Frame: 8 weeks
Mean 24-hour C-peptide levels (pmol/l). This is also a proxy for total 24-hour insulin secretion.
8 weeks
Insulin sensitivity
Time Frame: 8 weeks
Mean value of insulin sensitivity (dl/kg/min/μU/ml) across the three identical meal tolerance tests, as measured by the Oral Minimal Model
8 weeks
Beta-cell responsivity index (a measure of beta-cell function)
Time Frame: 8 weeks
Mean value of beta-cell responsivity across the three identical meal tolerance tests, as measured by the Oral Minimal Model
8 weeks
Glucose AUCs
Time Frame: 8 weeks
Glucose area-under-the-curve (mg/dl x hr) during each of three identical meal tolerance tests within a 24-hour period
8 weeks
Insulin AUC
Time Frame: 8 weeks
Insulin area-under-the-curve (mU/l x hr) during each of three identical meal tolerance tests within a 24-hour period
8 weeks
C-peptide AUC
Time Frame: 8 weeks
C-peptide area-under-the-curve (pmol/l x hr) during each of three identical meal tolerance tests within a 24-hour period
8 weeks
Peak glucose and mean amplitude of glycemic excursions (MAGE) glucose values
Time Frame: 8 weeks
mg/dl
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean 24-hour systolic and diastolic blood pressure
Time Frame: 8 weeks
mmHg
8 weeks
Daily maximum value, minimum value, and amplitude of systolic and diastolic blood pressure
Time Frame: 8 weeks
mmHg
8 weeks
Percentage of individuals with non-dipping blood pressure phenotypes
Time Frame: 8 weeks
8 weeks
Heart Rate
Time Frame: 8 weeks
beats per minute
8 weeks
Lipids
Time Frame: 8 weeks
Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
8 weeks
High Sensitivity C-Reactive Protein (hs-CRP)
Time Frame: 8 weeks
mg/l
8 weeks
Cortisol
Time Frame: 8 weeks
μg/dl
8 weeks
8-isoprostane
Time Frame: 8 weeks
pg/ml
8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 8 weeks
Percent adherence to assigned meal timing group
8 weeks
Body weight
Time Frame: 8 weeks
Change in body weight (kg) as measured by scale weight
8 weeks
Appetite across the day
Time Frame: 8 weeks
Subjective appetite as measured by Visual Analog Scales across the waking day
8 weeks
Appetite
Time Frame: 8 weeks
Subjective appetite as measured by retrospective Visual Analog Scales (VAS)
8 weeks
Appetite and Cravings
Time Frame: 8 weeks
Subjective appetite and cravings as measured by Likert scales
8 weeks
Eating Self-Efficacy
Time Frame: 8 weeks
Eating self-efficacy as measured by the Weight Loss Efficacy Lifestyle Questionnaire (WEL-8)
8 weeks
Sleepiness
Time Frame: 8 weeks
Sleepiness as measured by the Karolinska Sleepiness Scale (KSS) across the waking day
8 weeks
Current and Preferred Eating Times
Time Frame: 8 weeks
Current and preferred eating times as measured by a custom designed chrononutrition questionnaire
8 weeks
Mood
Time Frame: 8 weeks
Mood as measured by the Visual Analog Mood Scales (VAMS)
8 weeks
Positive Affect
Time Frame: 8 weeks
Positive Affect as measured by the PROMIS Positive Affect Short Form (PASF)
8 weeks
Stress
Time Frame: 8 weeks
Stress as measured by the Perceived Stress Scale (PSS)
8 weeks
Anxiety
Time Frame: 8 weeks
Anxiety as measured by the General Anxiety Disorder-7 (GAD-7)
8 weeks
Depression
Time Frame: 8 weeks
Depression as measured by the Patient Health Questionnaire-9 (PHQ-9)
8 weeks
Sleep Quality
Time Frame: 8 weeks
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PQSI) (This study will use the Global PQSI score, which ranges from 0-21, where higher values correspond to worse sleep quality.)
8 weeks
Sleep Timing, Duration, and Chronotype
Time Frame: 8 weeks
Sleep timing and duration as measured by the Munich Chronotype Questionnaire (MCTQ)
8 weeks
Chronotype
Time Frame: 8 weeks
Chronotype as assessed by the reduced Morningness-Eveningness Questionnaire (rMEQ)
8 weeks
GPAQ
Time Frame: 8 weeks
Physical activity as assessed by the General Physical Activity Questionnaire (GPAQ)
8 weeks
Exit Interview
Time Frame: 8 weeks
Qualitative data on experiences with the eating schedules and barriers, facilitators, and satisfaction factors
8 weeks
Sleep timing outcomes
Time Frame: 8 weeks
Sleep duration, sleep timing, sleep latency, and wake after sleep onset as measured by actigraphy watch. (These all have units of time)
8 weeks
Sleep efficiency and disruption
Time Frame: 8 weeks
Sleep efficiency (%) and awakenings (no.), as measured by actigraphy watch. (These all have dimensionless units.)
8 weeks
Other sleep outcomes
Time Frame: 8 weeks
Sleep Fragmentation Index (awakenings per time), as measured by actigraphy watch
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Courtney M. Peterson, Ph.D., University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-300001180
  • R01DK118236 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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