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Early vs. Late Time Restricted Eating vs. Daily Caloric Restriction

NCT05870982 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-03-24

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about time restricted eating as a weight loss intervention in adults with obesity. The main questions it aims to answer are:

1. How does the timing of the eating window (early vs late time restricted eating) affect weight loss and changes in metabolic risk factors?
2. How does time restricted eating compare to standard of care (daily caloric restriction) for weight loss and changes in metabolic risk factors?

Participants will be randomly assigned to either early time restricted eating, late time restricted eating, or daily caloric restriction.

1. They will be asked to follow the assigned dietary strategy for 1 year and will receive a group-based program for instruction and support.
2. They will be asked at several times during the year to have their weight and body composition measured, provide blood samples, track their food, and wear monitors for physical activity and sleep.

Conditions

  • Overweight and Obesity

Interventions

BEHAVIORAL

Early TRE

Participants will be instructed to eat only during an 8-hour window starting 1-2 hours after waking.

BEHAVIORAL

Late TRE

Participants will be instructed to eat only during an 8-hour window starting 5-6 hours after waking.

BEHAVIORAL

DCR

Participants will be instructed to reduce caloric intake by 25%.

Sponsors & Collaborators

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

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2027-03-31
Completion
2027-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05870982 on ClinicalTrials.gov