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Fatty Acid Infusion

Low-Dose Fatty Acids for Insulin Resistance (BCAA Trial)

Phase < 1
Recruiting
Led By Zoltan P Arany, MD, PhD
Research Sponsored by University of Pennsylvania
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights

BCAA Trial Summary

This trial is testing whether a low dose of fatty acids can cause mild insulin resistance in healthy volunteers, in order to select a dose for future studies.

Who is the study for?
Healthy volunteers who can consent and follow study procedures, without soy or egg allergies, severe heart disease, kidney issues, high cholesterol/triglycerides, diabetes history in family, BMI between 19-27 kg/m2. Must not have used investigational drugs recently or have certain chronic diseases.Check my eligibility
What is being tested?
The trial is testing how a low dose of fatty acids (Intralipid/heparin infusion) affects insulin sensitivity in healthy people to find the right dose that causes mild insulin resistance for future research.See study design
What are the potential side effects?
Potential side effects may include reactions related to the fat infusate due to soy or egg components in Intralipid and possible changes in blood sugar levels leading to mild insulin resistance.

BCAA Trial 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
Insulin Sensitivity

Side effects data

From 2010 Phase 2 & 3 trial • 100 Patients • NCT00672854
22%
Bacteremia
14%
Urinary tract infection,
10%
Pneumonia
10%
Cardiac arrhythmia,
8%
Wound infection,
4%
Vein irritation
2%
Congestive heart failure,
100%
80%
60%
40%
20%
0%
Study treatment Arm
Total Parenteral Nutrition (TPN) Given Intralipid 20%
Total Parenteral Nutrition (TPN) Given ClinOleic 20%

BCAA Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Medium Dose Fatty AcidsExperimental Treatment1 Intervention
Insulin sensitivity (rate of glucose disposal) in response to 60 ml/hr fatty acid infusion
Group II: Low Dose Fatty AcidsExperimental Treatment1 Intervention
Insulin sensitivity (rate of glucose disposal) in response to 30 ml/hr fatty acid infusion
Group III: SalineActive Control1 Intervention
Insulin sensitivity (rate of glucose disposal)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intralipid, 20% Intravenous Emulsion
2019
Completed Phase 4
~180

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,197 Total Patients Enrolled
3 Trials studying Insulin Resistance
3,095 Patients Enrolled for Insulin Resistance
Zoltan P Arany, MD, PhDPrincipal InvestigatorAssociate Professor of Medicine

Media Library

Intralipid (Fatty Acid Infusion) Clinical Trial Eligibility Overview. Trial Name: NCT03479671 — Phase < 1
Insulin Resistance Research Study Groups: Low Dose Fatty Acids, Medium Dose Fatty Acids, Saline
Insulin Resistance Clinical Trial 2023: Intralipid Highlights & Side Effects. Trial Name: NCT03479671 — Phase < 1
Intralipid (Fatty Acid Infusion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03479671 — Phase < 1

Frequently Asked Questions

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

Is there currently an open call for participants in this research?

"The clinical trial is still recruiting, as per information on the website of clinicaltrials.gov. The study was inaugurated January 1st 2020 and has been modified most recently on August 1 2022."

Answered by AI

How many individuals have been enlisted for this clinical investigation?

"Affirmative. Clinicaltrials.gov's information demonstrates that this study is currently recruiting participants, with a commencement date of January 1st 2020 and last edit on August 1st 2022. 12 individuals are needed between the single site for inclusion in the trial."

Answered by AI

Am I eligible for involvement in this medical experiment?

"This research is targeting 12 individuals aged 18 to 39, who display signs of insulin resistance. Those interested must be able to understand and agree with the study's protocol in writing."

Answered by AI

What medical conditions can be addressed through Intralipid, 20% Intravenous Emulsion treatment?

"Intravenous Emulsion, 20% can be administered to rectify nutritional deficits caused by parenteral nutrition and ascorbic acid deficiency."

Answered by AI

Does this clinical experiment include adults aged 18 and above?

"This clinical trial is only open to those aged 18-39. Furthermore, there are 72 trials specifically for minors and 758 studies targeting patients over 65 years old."

Answered by AI

What further research has been done into the effects of Intralipid, 20% Intravenous Emulsion?

"Presently, there are 13 clinical trials dedicated to Intralipid, 20% Intravenous Emulsion. Three of these live studies have advanced to Phase 3 testing. Despite the majority taking place in Boston, Massachusetts, 27 centres across the US are running investigations on this drug's efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Jan 2025