RecruitingNot ApplicableNCT07209202

Fructose Intestinal Gluconeogenesis

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


Sponsor

Touro University, California

Enrollment

40 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 55 Years

Inclusion Criteria1

  • BMI 30 to 38 kg/m2 (obese group) or BMI 19 to 25 kg/m2 (lean group)

Exclusion Criteria12

  • Pregnancy or lactation within the past six months;
  • Type 1 or 2 diabetes mellitus (including fasting glucose ≥126 mg/dL, HgbA1c ≥6.5%);
  • History of liver disease or AST and ALT 2x above the upper limit of normal;
  • Fasting triglyceride \> 300 mg/dl; total cholesterol levels above the 95th percentile for age and sex;
  • Hemoglobin (Hgb) \<12.5g/d or hematocrit\<3x Hgb value;
  • Report of HIV or hepatitis B or C infection;
  • History of cancer, other than basal cell or squamous cell carcinoma or kidney disease stage 3 or higher or patients currently on dialysis;
  • Use of any anti-diabetic medications or hypolipidemic agents in the past six months;
  • History of surgical procedure for obesity;
  • Change in body weight \>5% in the past six months (by self-report);
  • History of other conditions known to affect insulin sensitivity and lipid metabolism (e.g., polycystic ovary syndrome), history of galactosemia, hereditary fructose intolerance, or who test positive for fructose malabsorption at screening;
  • Known intolerance to acetaminophen.

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Interventions

OTHERHigh fructose meal

Liquid meals containing 55% total carbohydrate (16% fructose), 30% fat, 15% protein.

OTHERLow fructose meal

55% total carbohydrate (6% fructose), 30% fat, 15% protein.

OTHER13C labeled fructose, oral

Tracer amount of 13C labeled fructose administered orally in the meals.

OTHER13C labeled fructose, intravenous

Tracer amount of 13C fructose administered intravenously


Locations(1)

Touro University California

Vallejo, California, United States

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NCT07209202


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