Fructose Diets for Prediabetes

Overseen By Jean-Marc Schwarz, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Touro University, California

Must not be taking: Anti-diabetic, Hypolipidemic

Disqualifiers: Diabetes, Liver disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Jean-Marc Schwarz, PhD

Principal Investigator

Touro University, California

Are You a Good Fit for This Trial?

This trial is for adults with a BMI of 22-35 who are either healthy, prediabetic (HbA1c between 5.7% and 6.5%), or have high fasting insulin but not diabetes. Participants should not have had significant weight changes recently, be free from liver disease, hepatitis, HIV, cancer history, and cannot be pregnant or on certain medications.

Inclusion Criteria

I am prediabetic or have high insulin but not diabetic.

Your body mass index (BMI) is between 22 and 35.

Your fasting insulin, fasting glucose, and HbA1c levels are within specific normal ranges.

Exclusion Criteria

Pregnancy or lactation within the past six months

You have hepatitis or HIV infection.

Known intolerance to acetaminophen or components of the liquid test meals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume meals with varying fructose content and labeled compounds to study metabolic effects

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High fructose, fructose labeled meal
• High fructose, pyruvate labeled meal
• Low fructose, fructose labeled meal
• Low fructose, pyruvate labeled meal

Trial Overview The study aims to understand how fructose in meals affects fat synthesis and blood sugar levels by comparing the effects of meals with different fructose content and labeling (either low or high fructose labeled with pyruvate). The participants' response to these meals will help clarify fructose's role in metabolism.

How Is the Trial Designed?

Group I: Low fructose meal, with pyruvate label Experimental Treatment 1 Intervention

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

Group II: Low fructose meal, with fructose label Experimental Treatment 1 Intervention

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

Group III: High fructose meal, with pyruvate label Experimental Treatment 1 Intervention

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

Group IV: High fructose meal, with fructose label Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Touro University, California

Lead Sponsor

Trials

8

Recruited

1,100+