35 Participants Needed

Fructose Diets for Prediabetes

Recruiting in Vallejo (>99 mi)
SC
JS
Overseen ByJean-Marc Schwarz, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Touro University, California
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

Research Team

JS

Jean-Marc Schwarz, PhD

Principal Investigator

Touro University, California

Eligibility Criteria

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
See 8 more

Timeline

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

Treatment Details

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.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Low fructose meal, with pyruvate labelExperimental Treatment1 Intervention
2-13C pyruvate incorporated into a meal with low fructose content
Group II: Low fructose meal, with fructose labelExperimental Treatment1 Intervention
2-13C fructose incorporated into a meal with low fructose content
Group III: High fructose meal, with pyruvate labelExperimental Treatment1 Intervention
2-13C pyruvate incorporated into a meal with high fructose content
Group IV: High fructose meal, with fructose labelExperimental Treatment1 Intervention
2-13C fructose incorporated into a meal with high fructose content

Find a Clinic Near You

Who Is Running the Clinical Trial?

Touro University, California

Lead Sponsor

Trials
8
Recruited
1,100+