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Precision Nutrition and Metabolic Function

NCT04131166 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-07-11

No results posted yet for this study

Summary

The purposes of this study are: 1) to determine the mechanisms responsible for the development of cardiometabolic complications in some, but not all people with obesity; 2) determine the best dietary approach for cardiometabolic health; and 3) understand why some people have a stable metabolic phenotype over time whereas cardiometabolic health improves or worsens in others.

Conditions

Interventions

BEHAVIORAL

Mediterranean diet

A Mediterranean-type diet will be consumed for 4 to 8 weeks in the weight stable state with all meals provided.

BEHAVIORAL

Low-carbohydrate, ketogenic diet

A low-carbohydrate, ketogenic diet will be consumed for 4 to 8 weeks in the weight stable state with all meals provided.

BEHAVIORAL

Low-fat diet

A low-fat diet will be consumed for 4 to 8 weeks in the weight stable state with all meals provided.

OTHER

Annual follow-up testing for 5 years

Annual follow-up testing with no restrictions on dietary intake during periods between annual testing.

Sponsors & Collaborators

  • Centene Corporation

    collaborator UNKNOWN

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Samuel Klein, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2029-10-01
Completion
2029-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04131166 on ClinicalTrials.gov