Healthy ParticipantsFIGNCT07209202

Fructose Intestinal Gluconeogenesis

A study testing High fructose meal, Low fructose meal and 13C labeled fructose, oral in people with Healthy Participants and Obese But Otherwise Healthy Participants, run by Touro University, California at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants, Obese But Otherwise Healthy Participants
What is being tested?: High fructose meal, Low fructose meal and 13C labeled fructose, oral
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 2 Mar 2026to Jun 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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;

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sally Chiu, PhD contact

707-638-5404

schiu2@touro.edu

Lisa Johnson, RN contact

ljohnson19@touro.edu

United States1 site, 1 recruiting

Touro University California
Vallejo, California, 95492
Sally Chiu, PhD, schiu2@touro.edu
Recruiting

Other trials in United States

About this study

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

Read the detailed description

Qualified participants will undergo a sugar tolerance test at baseline and then randomized to undergo four separate outpatient tracer/feeding studies in a crossover fashion. After an overnight fast, a six-hour fed tracer study will be initiated, during which participants will consume liquid meals containing stable isotopes at regular intervals and receive other isotopes intravenously. Meal composition will differ only by fructose content (High vs. Low) and tracer (oral vs. intravenous 13C-labeled fructose). Blood and urine samples will be collected frequently throughout the study. Each visit will be performed approximately three weeks apart. Vital signs and anthropometrics will be measured at each clinic visit.

Conditions: Healthy Participants, Obese But Otherwise Healthy Participants
Being tested: High fructose meal, Low fructose meal, 13C labeled fructose, oral, 13C labeled fructose, intravenous
Keywords: Fructose, Sugar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High fructose mealOther
Liquid meals containing 55% total carbohydrate (16% fructose), 30% fat, 15% protein.
Low fructose mealOther
55% total carbohydrate (6% fructose), 30% fat, 15% protein.
13C labeled fructose, oralOther
Tracer amount of 13C labeled fructose administered orally in the meals.
13C labeled fructose, intravenousOther
Tracer amount of 13C fructose administered intravenously

Study groups in NCT07209202
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Low fructose meal; Other: 13C labeled fructose, intravenous

What is being measured

The primary outcome is the main question the study is designed to answer.

Fru-GNG
Total amount of fructose converted to glucose
Measured: 6 hours
Fru-hGNG
Amount of fructose converted to glucose in the liver
Measured: 6 hours
Fru-iGNG
Amount of fructose converted to glucose in the intestine
Measured: 6 hours
De novo lipogenesis (DNL)
Percent of newly synthesized palmitate
Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 2026Jun 2030

First posted6 Oct 2025
Study start2 Mar 2026
Primary completionJun 2030 (estimated)
Study completionJun 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07209202
Sponsor's protocol ID: M-2624
Other IDs: R01DK140477
Acronym: FIG
Status last verified: Mar 2026
First submitted: 30 Sep 2025
Last updated: 6 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The de-identified clinical and laboratory data set will be made available upon request to academic investigators.

Interested in taking part?

Sally Chiu, PhD

707-638-5404

schiu2@touro.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fructose Metabolism Effects on the Liver: Unraveling the Role of Defective Intestinal GNG in Individuals With Obesity
ClinicalTrials.gov ID: NCT07209202
Acronym / sponsor ID: FIG / M-2624
Conditions: Healthy Participants, Obese But Otherwise Healthy Participants
Keywords: Fructose, Sugar
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 40 participants (estimated)
Lead sponsor: Touro University, CaliforniaUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 2 Mar 2026 (actual)
Primary completion: Jun 2030 (estimated)
Study completion: Jun 2030 (estimated)
First posted: 6 Oct 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
High fructose meals, oral 13C fructose	Experimental	Other: High fructose meal, Other: 13C labeled fructose, oralLiquid meals will be fed, containing 55% total carbohydrate (16% fructose), 30% fat, 15% protein, and a tracer amount of 13C fructose.
High Fructose Meals, IV 13C Fructose	Experimental	Other: High fructose meal, Other: 13C labeled fructose, intravenousLiquid meals will be fed, containing 55% total carbohydrate (16% fructose), 30% fat, 15% protein. A tracer amount of 13C fructose will be administered intravenously.
Low fructose meals, oral fructose tracer	Experimental	Other: Low fructose meal, Other: 13C labeled fructose, oralLiquid meals will be fed, containing 55% total carbohydrate (6% fructose), 30% fat, 15% protein, and a tracer amount of 13C fructose.
Low fructose meals, IV 13C fructose tracer	Experimental	Other: Low fructose meal, Other: 13C labeled fructose, intravenousLiquid meals will be fed, containing 55% total carbohydrate (6% fructose), 30% fat, 15% protein. A tracer amount of 13C fructose will be administered intravenously.

Who may qualify

Ages: 20 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High fructose mealLiquid meals containing 55% total carbohydrate (16% fructose), 30% fat, 15% protein.	Other	High Fructose Meals, IV 13C Fructose, High fructose meals, oral 13C fructose
Low fructose meal55% total carbohydrate (6% fructose), 30% fat, 15% protein.	Other	Low fructose meals, IV 13C fructose tracer, Low fructose meals, oral fructose tracer
13C labeled fructose, oralTracer amount of 13C labeled fructose administered orally in the meals.	Other	High fructose meals, oral 13C fructose, Low fructose meals, oral fructose tracer
13C labeled fructose, intravenousTracer amount of 13C fructose administered intravenously	Other	High Fructose Meals, IV 13C Fructose, Low fructose meals, IV 13C fructose tracer

Primary outcome

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
Individual participant dataSharing planned: Yes. The de-identified clinical and laboratory data set will be made available upon request to academic investigators.

Related trials for Healthy Participants

Active, not recruitingPhase 1/2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Sally Chiu, PhD contact

707-638-5404

schiu2@touro.edu

Lisa Johnson, RN contact

ljohnson19@touro.edu

Jean-Marc Schwarz, PhD principal investigator

Touro University, California

Grace M Jones, PhD principal investigator

Touro University, California

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sally Chiu, PhD (707-638-5404, schiu2@touro.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fru-GNG (time frame: 6 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07209202.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.