Clinical trial

Fructose Intestinal Gluconeogenesis

Recruiting now · Not applicable · 1 countries · Registry ID NCT07209202

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 55 Years

SexAll

Healthy volunteersAccepted

ConditionHealthy Participants, Obese But Otherwise Healthy Participants

Full registry criteria

Inclusion Criteria: * BMI 30 to 38 kg/m2 (obese group) or BMI 19 to 25 kg/m2 (lean group) Exclusion Criteria: * 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.

Treatments and study arms

High fructose meal

Other

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

Low fructose meal

Other

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

13C labeled fructose, oral

Other

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

13C labeled fructose, intravenous

Other

Tracer amount of 13C fructose administered intravenously

Primary outcomes

Fru-GNG6 hours

Total amount of fructose converted to glucose

Fru-hGNG6 hours

Amount of fructose converted to glucose in the liver

Fru-iGNG6 hours

Amount of fructose converted to glucose in the intestine

De novo lipogenesis (DNL)6 hours

Percent of newly synthesized palmitate

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Touro University California🇺🇸 Vallejo, California, United States

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Sally Chiu, PhDContact