NCT04131166

Precision Nutrition and Metabolic Function

Active, enrolled NA Last updated 11 July 2025

What this trial tests

NA trial testing Mediterranean diet in Obesity in 300 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 October 2019

Primary endpoint
1 October 2029

31 December 2029

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	300
Start date	8 October 2019
Primary completion	1 October 2029
Estimated completion	31 December 2029
Sites	1 location across United States

Drugs / interventions tested

• Mediterranean diet
• Low-carbohydrate, ketogenic diet
• Low-fat diet
• Annual follow-up testing for 5 years

Conditions studied

• Obesity — all drugs for Obesity →
• Insulin Resistance — all drugs for Insulin Resistance →

Sponsor

Washington University School of Medicine

Who can join

Adults 18 to 55, any sex, with Obesity or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Potential Use of Exosomes as Diagnostic Biomarkers and in Targeted Drug Delivery: Progress in Clinical and Preclinical Applications.
   Huda MN, Nafiujjaman M, Deaguero IG, Okonkwo J, et al · · 2021 · cited 160× · PMID 33988964 · DOI 10.1021/acsbiomaterials.1c00217
2. β Cell function and plasma insulin clearance in people with obesity and different glycemic status.
   Mittendorfer B, Patterson BW, Smith GI, Yoshino M, et al · · 2022 · cited 49× · PMID 34905513 · DOI 10.1172/jci154068
3. Insight into the Functional Dynamics and Challenges of Exosomes in Pharmaceutical Innovation and Precision Medicine.
   Sharma A, Yadav A, Nandy A, Ghatak S. · · 2024 · cited 40× · PMID 38931833 · DOI 10.3390/pharmaceutics16060709
4. Critical Evaluation of Indices Used to Assess β-Cell Function.
   Cao C, Koh HE, Reeds DN, Patterson BW, et al · · 2024 · cited 4× · PMID 38015795 · DOI 10.2337/db23-0613
5. Effects of Obesity and Hyperglycemia on Postprandial Insulin-Mediated and Non-Insulin-Mediated Glucose Disposal.
   Mittendorfer B, Patterson BW, Smith GI, Yoshino M, et al · · 2025 · cited 3× · PMID 39499792 · DOI 10.2337/dc24-1280
6. Impaired plasma glucose clearance is a key determinant of fasting hyperglycemia in people with obesity.
   Mittendorfer B, van Vliet S, Smith GI, Petersen MC, et al · · 2024 · cited 2× · PMID 38228469 · DOI 10.1002/oby.23963
7. Influence of obesity and insulin resistance with hepatic steatosis on the human plasma lipidome.
   Petersen MC, Smith GI, Armando AM, Su X, et al · · 2026 · PMID 41456639 · DOI 10.1016/j.jlr.2025.100969
8. Potential Mechanisms of Precision Nutrition-Based Interventions for Managing Obesity
   Mehta N, Huey S, Kuriyan R, Peña-Rosas J, et al · · 2024