Health TrialsbyHealthPanel

Fructose Intestinal Gluconeogenesis

ConditionsHealthy ParticipantsObese But Otherwise Healthy Participants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-55
SponsorTouro University, California

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

  • High fructose meal

    Other intervention

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

  • Low fructose meal

    Other intervention

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

  • 13C labeled fructose, oral

    Other intervention

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

  • 13C labeled fructose, intravenous

    Other intervention

    Tracer amount of 13C fructose administered intravenously

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: High fructose meals, oral 13C fructoseExperimental treatment 2 interventions
Group B: High Fructose Meals, IV 13C FructoseExperimental treatment 2 interventions
Group C: Low fructose meals, oral fructose tracerExperimental treatment 2 interventions
Group D: Low fructose meals, IV 13C fructose tracerExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Fru-GNG

Total amount of fructose converted to glucose

Time frame
6 hours
2

Fru-hGNG

Amount of fructose converted to glucose in the liver

Time frame
6 hours
3

Fru-iGNG

Amount of fructose converted to glucose in the intestine

Time frame
6 hours
4

De novo lipogenesis (DNL)

Percent of newly synthesized palmitate

Time frame
6 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Touro University, California

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
Apply now