Fructose Intestinal Gluconeogenesis

NCT07209202 | Recruiting

• 2 other identifiers: M-2624R01DK140477
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Fructose; Sugar

Outcome Measures

Primary Outcomes (4)

• Fru-GNG

  Total amount of fructose converted to glucose

  6 hours

• Fru-hGNG

  Amount of fructose converted to glucose in the liver

  6 hours

• Fru-iGNG

  Amount of fructose converted to glucose in the intestine

  6 hours

• De novo lipogenesis (DNL)

  Percent of newly synthesized palmitate

  6 hours

Study Arms (4)

High fructose meals, oral 13C fructose

EXPERIMENTAL

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

Other: High fructose meal; Other: 13C labeled fructose, oral

High Fructose Meals, IV 13C Fructose

EXPERIMENTAL

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.

Other: High fructose meal; Other: 13C labeled fructose, intravenous

Low fructose meals, oral fructose tracer

EXPERIMENTAL

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

Other: Low fructose meal; Other: 13C labeled fructose, oral

Low fructose meals, IV 13C fructose tracer

EXPERIMENTAL

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.

Other: Low fructose meal; Other: 13C labeled fructose, intravenous

Interventions

High fructose meal OTHER

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

High Fructose Meals, IV 13C Fructose; High fructose meals, oral 13C fructose

Low fructose meal OTHER

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

Low fructose meals, IV 13C fructose tracer; Low fructose meals, oral fructose tracer

13C labeled fructose, oral OTHER

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

High fructose meals, oral 13C fructose; Low fructose meals, oral fructose tracer

13C labeled fructose, intravenous OTHER

Tracer amount of 13C fructose administered intravenously

High Fructose Meals, IV 13C Fructose; Low fructose meals, IV 13C fructose tracer

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Touro University, California: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Touro University California

Vallejo, California, 95492, United States

RECRUITING

Study Officials

• Jean-Marc Schwarz, PhD

  Touro University, California

  PRINCIPAL INVESTIGATOR

• Grace M Jones, PhD

  Touro University, California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally Chiu, PhD

CONTACT

707-638-5404; schiu2@touro.edu

Lisa Johnson, RN

CONTACT

ljohnson19@touro.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 6, 2025
• Study Start: March 2, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study data will be made available for at least 5 years from publication of the primary manuscript.
• Access Criteria: Academic investigators may request data and supporting information upon request to the PI.

Locations

US (1)