Fructose: Substrate, Stimulus, or Both?

NCT ID: NCT04168372

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-15

Study Completion Date

2024-11-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This objective of this study is to use sensitive methodology under controlled conditions to investigate the mechanisms by which fructose consumption contributes to excess fatty acid synthesis and elevations in blood glucose levels following consumption of meals containing fructose.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Resistance Insulin Sensitivity Pre Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High fructose meal, with fructose label

2-13C fructose incorporated into a meal with high fructose content

Group Type EXPERIMENTAL

High fructose, fructose labeled meal

Intervention Type OTHER

Liquid meal containing high fructose (16% of energy), labeled with 2-13C fructose

High fructose meal, with pyruvate label

2-13C pyruvate incorporated into a meal with high fructose content

Group Type EXPERIMENTAL

High fructose, pyruvate labeled meal

Intervention Type OTHER

Liquid meal containing high fructose (16% of energy), labeled with 2-13C pyruvate

Low fructose meal, with fructose label

2-13C fructose incorporated into a meal with low fructose content

Group Type EXPERIMENTAL

Low fructose, fructose labeled meal

Intervention Type OTHER

Liquid meals containing low fructose (6% of energy), labeled with 2-13C fructose

Low fructose meal, with pyruvate label

2-13C pyruvate incorporated into a meal with low fructose content

Group Type EXPERIMENTAL

Low fructose, pyruvate labeled meal

Intervention Type OTHER

Liquid meal containing low fructose (6% of energy), labeled with 2-13C pyruvate

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High fructose, fructose labeled meal

Liquid meal containing high fructose (16% of energy), labeled with 2-13C fructose

Intervention Type OTHER

High fructose, pyruvate labeled meal

Liquid meal containing high fructose (16% of energy), labeled with 2-13C pyruvate

Intervention Type OTHER

Low fructose, fructose labeled meal

Liquid meals containing low fructose (6% of energy), labeled with 2-13C fructose

Intervention Type OTHER

Low fructose, pyruvate labeled meal

Liquid meal containing low fructose (6% of energy), labeled with 2-13C pyruvate

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Body Mass Index 22 to 35 kg/m2
* Prediabetic (HbA1c 5.7% to 6.5%) or hyperinsulinemic (fasting insulin ≥12 µIU/mL) but non-diabetic (fasting glucose \<126mg/dL and HbA1c \< 6.5%) ; or normal control (fasting insulin \<10 µIU/mL, fasting glucose \<100 mg/dL, and HbA1c \< 5.7%)

Exclusion Criteria

* Pregnancy or lactation within the past six months
* Type 1 or 2 diabetes mellitus
* History of liver disease or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2x the upper limit of normal (ULN);
* Fasting triglyceride or total cholesterol levels above 95th percentile for age and sex;
* Hemoglobin or hematocrit below the lower limit of normal for sex;
* Report of hepatitis or HIV infection;
* History of cancer, use of any anti-diabetic medications or hypolipidemic agents in the past six months;
* History of surgical procedure for obesity;
* Self-reported change in body weight \>5% in the past six months;
* History of other conditions known to affect insulin sensitivity and lipid metabolism;
* Known intolerance to acetaminophen or components of the liquid test meals.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Touro University, California

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Marc Schwarz, PhD

Role: PRINCIPAL_INVESTIGATOR

Touro University, California

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Touro University California

Vallejo, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M-3018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fructose Intestinal Gluconeogenesis
NCT07209202 NOT_YET_RECRUITING NA