NCT07209202 · Touro University, California
Fructose Intestinal Gluconeogenesis
(FIG)
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.
View original scientific description
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.
Interventions
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
Primary outcome measures
Fru-GNG
Time frame: 6 hours
Total amount of fructose converted to glucose
Fru-hGNG
Time frame: 6 hours
Amount of fructose converted to glucose in the liver
Fru-iGNG
Time frame: 6 hours
Amount of fructose converted to glucose in the intestine
De novo lipogenesis (DNL)
Time frame: 6 hours
Percent of newly synthesized palmitate
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Vallejo, California
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 6, 2026 · Source of record for eligibility and locations