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The Influence of Time-Restricted Eating in Patients With Metabolic Syndrome

NCT04057339 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2023-04-06

No results posted yet for this study

Summary

In a randomized controlled trial, the investigators intend to measure the health impact of TRE in patients with metabolic syndrome (with three or more of the following criteria: increased waist circumference, abnormal cholesterol levels, elevated blood pressure, or elevated blood sugar), who habitually eat for more than 14 hours every day. Patients will be randomly assigned to a control group of behavioral nutrition counseling (standard of care) or the intervention group of behavioral nutrition counseling with the addition of adopting a 8-10 hour eating window for 12 weeks (TRE).

Conditions

  • Metabolic Syndrome
  • Pre-Diabetes

Interventions

BEHAVIORAL

Time Restricted Eating + Standard of Care

Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.

BEHAVIORAL

Standard of Care

Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.

Sponsors & Collaborators

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

    collaborator NIH

  • Salk Institute for Biological Studies

    collaborator OTHER

  • University of California, San Diego

    lead OTHER

Principal Investigators

  • Pam Taub, MD · Associate Professor of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-08
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04057339 on ClinicalTrials.gov