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

NCT03504683 | Completed

• 2 other identifiers: IRB-300001180R01DK118236
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

PreDiabetes

Outcome Measures

Primary Outcomes (9)

• Mean 24-hour glucose levels

  Mean 24-hour glucose levels (mg/dl)

  8 weeks

• Mean 24-hour insulin levels

  Mean 24-hour insulin levels (mU/l)

  8 weeks

• Mean 24-hour C-peptide levels

  Mean 24-hour C-peptide levels (pmol/l). This is also a proxy for total 24-hour insulin secretion.

  8 weeks

• Insulin sensitivity

  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)

  Mean value of beta-cell responsivity across the three identical meal tolerance tests, as measured by the Oral Minimal Model

  8 weeks

• Glucose AUCs

  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

  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

  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

  mg/dl

  8 weeks

Secondary Outcomes (8)

• Mean 24-hour systolic and diastolic blood pressure

  8 weeks

• Daily maximum value, minimum value, and amplitude of systolic and diastolic blood pressure

  8 weeks

• Percentage of individuals with non-dipping blood pressure phenotypes

  8 weeks

• Heart Rate

  8 weeks

• Lipids

  8 weeks

Other Outcomes (21)

• Adherence

  8 weeks

• Body weight

  8 weeks

• Appetite across the day

  8 weeks

Study Arms (3)

Early TRE

EXPERIMENTAL

Behavioral: Early TRE

Mid-day TRE

EXPERIMENTAL

Behavioral: Mid-day TRE

Control Schedule

PLACEBO COMPARATOR

Behavioral: Control Schedule

Interventions

Early TRE BEHAVIORAL

Eat between 8 am - 3 pm (or 7 am - 2 pm, if an early riser)

Also known as: eTRE

Early TRE

Mid-day TRE BEHAVIORAL

Eat between 1 pm - 8 pm (or 12 pm - 7 pm, if an early riser)

Also known as: mTRE

Mid-day TRE

Control Schedule BEHAVIORAL

Eat between 8 am - 8 pm (or 7 am - 7 pm, if an early riser)

Control Schedule

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Courtney M. Peterson, Ph.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomization will be stratified by fasting insulin. Within the lowest insulin strata, randomization will be further stratified by biological sex.

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: August 17, 2020
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)