NCT04131166

Precision Nutrition and Metabolic Function

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Excess adiposity causes alterations in metabolic function including impaired glucose homeostasis and insulin resistance, which are important risk factors for type 2 diabetes (T2D) and cardiovascular disease (CVD). Not all people with obesity experience the typical metabolic complications associated with obesity. Approximately 25% of people with obesity are protected from the adverse metabolic effects of excess fat accumulation and are considered to be metabolically healthy based on their normal response to insulin. The mechanism(s) responsible for the differences in metabolic function among people with obesity is not known, but is likely to be multifactorial including dietary intake. The risk for developing T2D and CVD is also well known to increase with age, however, not all people that are metabolically healthy convert to a metabolically unhealthy phenotype over time. The mechanisms responsible for the stability of health status in some, but not all adults, are unclear. The overall goals of this study are to: i) determine the mechanisms responsible for the development of cardiometabolic complications in participants who will be carefully characterized into 3 distinct groups \[metabolically normal lean, metabolically normal obese and metabolically abnormal obese\], ii) to determine the optimal dietary approach for cardiometabolic health independent of weight change in people with metabolically abnormal obesity, and iii) perform a comprehensive longitudinal assessment of cardiometabolic health to understand why some people have a stable metabolic phenotype over time whereas cardiometabolic health improves or worsens in others.

Conditions

• Obesity
• Insulin Resistance

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-08
• Primary completion: 2029-10-01
• Completion: 2029-12-31
• First posted: 2019-10-18
• Last updated: 2025-07-11

Locations

1 site across 1 country: United States