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Fructose Diets for Prediabetes

N/A
Recruiting
Led By Jean-Marc Schwarz, PhD
Research Sponsored by Touro University, California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
History of surgical procedure for obesity
History of liver disease or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2x the upper limit of normal (ULN)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights

Summary

This trial will study how fructose affects blood sugar and fat production.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves dietary interventions without pharmaceutical drugs, side effects may include digestive discomfort related to meal consumption but are expected to be minimal.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery to help with weight loss.
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My liver is healthy and my liver enzyme levels are not more than twice the normal limit.
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I have lost or gained more than 5% of my body weight in the last 6 months.
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I have type 1 or type 2 diabetes.
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My cholesterol or triglyceride levels are very high for my age and sex.
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My blood hemoglobin or hematocrit levels are low for my gender.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hepatic fractional de novo lipogenesis in triglyceride rich lipoprotein (TRL)
Uridine Diphosphate Glucose
Rate of appearance of blood glucose from gluconeogenesis
Secondary outcome measures
Enteral (chylomicron) fractional de novo lipogenesis (DNL)
Extrasplanchnic fructose
Hepatic (VLDL) fractional de novo lipogenesis (DNL)
+6 more

Trial Design

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 Location

Who is running the clinical trial?

Touro University, CaliforniaLead Sponsor
7 Previous Clinical Trials
1,026 Total Patients Enrolled
Jean-Marc Schwarz, PhDPrincipal InvestigatorTouro University, California
3 Previous Clinical Trials
149 Total Patients Enrolled

Media Library

High fructose, fructose labeled meal Clinical Trial Eligibility Overview. Trial Name: NCT04168372 — N/A
Prediabetes Research Study Groups: High fructose meal, with fructose label, High fructose meal, with pyruvate label, Low fructose meal, with fructose label, Low fructose meal, with pyruvate label
Prediabetes Clinical Trial 2023: High fructose, fructose labeled meal Highlights & Side Effects. Trial Name: NCT04168372 — N/A
High fructose, fructose labeled meal 2023 Treatment Timeline for Medical Study. Trial Name: NCT04168372 — N/A
~6 spots leftby Jul 2025
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