Recruiting

Fructose Intake

Sponsor:

Touro University, California

Code:

NCT07209202

Conditions

Healthy Participants

Obese But Otherwise Healthy Participants

Eligibility Criteria

Sex: All

Age: 20 - 55

Healthy Volunteers: Accepted

Interventions

High fructose meal

Low fructose meal

13C labeled fructose, oral

13C labeled fructose, intravenous

Study Details

Brief 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.

Conditions

Healthy Participants

Obese But Otherwise Healthy Participants

Study ID

NCT07209202

Start date

Mar 2, 2026

Status verified date

Mar, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: High fructose meals, oral 13C fructose

Liquid meals will be fed, containing 55% total carbohydrate (16% fructose), 30% fat, 15% protein, and a tracer amount of 13C fructose.

experimental: High Fructose Meals, IV 13C Fructose

Liquid meals will be fed, containing 55% total carbohydrate (16% fructose), 30% fat, 15% protein. A tracer amount of 13C fructose will be administered intravenously.

experimental: Low fructose meals, oral fructose tracer

Liquid meals will be fed, containing 55% total carbohydrate (6% fructose), 30% fat, 15% protein, and a tracer amount of 13C fructose.

experimental: Low fructose meals, IV 13C fructose tracer

Liquid meals will be fed, containing 55% total carbohydrate (6% fructose), 30% fat, 15% protein. A tracer amount of 13C fructose will be administered intravenously.

Interventions

High fructose meal

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

Low fructose meal

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

13C labeled fructose, oral

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

13C labeled fructose, intravenous

Tracer amount of 13C fructose administered intravenously

Primary outcome measure

  • Fru-GNG [ Time Frame: 6 hours ]
  • Fru-hGNG [ Time Frame: 6 hours ]
  • Fru-iGNG [ Time Frame: 6 hours ]
  • De novo lipogenesis (DNL) [ Time Frame: 6 hours ]

Central Contacts and Locations

Central contacts

Sally Chiu, PhD

707-638-5404schiu2@touro.edu

Lisa Johnson, RN

ljohnson19@touro.edu

Locations

Touro University California

Recruiting

Vallejo, California, United States, 95492

Contacts

Sally Chiu, PhD

schiu2@touro.edu

More Information

Sponsor

Touro University, California

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • Fructose
  • Sugar

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Touro University, California on 2026-03-06.