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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
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%)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights

Study 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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am prediabetic or have high insulin but not diabetic.

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the qualifications for taking part in this research endeavor?

"The requirements for being accepted into this medical trial necessitate that patients have insulin resistance and be a part of the 20-55 demographic. In total, 36 individuals will be granted entry to participate."

Answered by AI

Do elderly individuals aged 70 or above qualify for this experiment?

"This clinical trial requires that all participants are at least 20 years of age, but no older than 55."

Answered by AI

What objectives are researchers expecting to achieve from this trial?

"This 6-hour trial aims to assess Hepatic fractional de novo lipogenesis in triglyceride rich lipoprotein (TRL). Additionally, this experiment will measure Extrasplanchnic fructose through total plasma fructose analysis, serum glucose concentration with fasting and postprandial serum triglycerides levels, Whole body fructose oxidation using 13C atom % excess in exhaled breath, and VCO2 via indirect calorimetry."

Answered by AI

What is the current enrollment rate for this research project?

"Affirmative, the information presented on clinicaltrials.gov specifies that this trial is actively recruiting participants. This medical initiative was initially posted 15th September 2019 and has been recently modified 25th April 2022; 36 volunteers are required from a single site."

Answered by AI

Are new participants being recruited for this clinical research endeavor?

"Affirmative, according to the clinicaltrials.gov website this research endeavor is actively looking for suitable patients. It was first published on September 15th 2019 and its most recent update occurred April 25th 2022. 36 individuals are required at a single trial site in order for it to be completed successfully."

Answered by AI
~1 spots leftby Jun 2024