NCT07209202

Fructose Intestinal Gluconeogenesis

Fructose Metabolism Effects on the Liver: Unraveling the Role of Defective Intestinal GNG in Individuals With Obesity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Touro University, California · Academic / Other
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will test the hypothesis that within a defined range of fructose intake, the ability to convert fructose to glucose (via gluconeogenesis) in the small intestine plays a protective role for the liver, shielding it from the deleterious effects of fructose. We will investigate whether this protective effect of the intestine is impaired in individuals with obesity.

Detailed description

Qualified participants will undergo a sugar tolerance test at baseline and then randomized to undergo four separate outpatient tracer/feeding studies in a crossover fashion. After an overnight fast, a six-hour fed tracer study will be initiated, during which participants will consume liquid meals containing stable isotopes at regular intervals and receive other isotopes intravenously. Meal composition will differ only by fructose content (High vs. Low) and tracer (oral vs. intravenous 13C-labeled fructose). Blood and urine samples will be collected frequently throughout the study. Each visit will be performed approximately three weeks apart. Vital signs and anthropometrics will be measured at each clinic visit.

Conditions

• Healthy Participants
• Obese But Otherwise Healthy Participants

Interventions

Type	Name	Description
OTHER	High fructose meal	Liquid meals containing 55% total carbohydrate (16% fructose), 30% fat, 15% protein.
OTHER	Low fructose meal	55% total carbohydrate (6% fructose), 30% fat, 15% protein.
OTHER	13C labeled fructose, oral	Tracer amount of 13C labeled fructose administered orally in the meals.
OTHER	13C labeled fructose, intravenous	Tracer amount of 13C fructose administered intravenously

Timeline

• Start date: 2026-03-02
• Primary completion: 2030-06-01
• Completion: 2030-06-01
• First posted: 2025-10-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States