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

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

Interventions

BEHAVIORAL

Early TRE

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

BEHAVIORAL

Mid-day TRE

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

BEHAVIORAL

Control Schedule

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Courtney M. Peterson, Ph.D. · University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-17

Primary Completion

2025-11-24

Completion

2025-11-24

Countries

• United States

Study Locations