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Fatty Acid Elevation for Obesity

Phase 1 & 2
Recruiting
Led By Janice Hwang, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obese individuals: BMI >30 kg/m^2
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through end of study (up to 12 hours)
Awards & highlights

Study Summary

This trial will study how obesity affects brain glucose transport and whether this is associated with reduced metabolism.

Who is the study for?
This trial is for adults aged 18-45 with obesity (BMI >30 kg/m2) or normal weight (BMI 17-25 kg/m2), and HbA1C levels below 6.5%. Participants should not have significant health issues like liver, kidney, or heart diseases, uncontrolled high blood pressure, abnormal thyroid or clotting tests, recent drastic weight changes, substance abuse problems, or be pregnant/breastfeeding.Check my eligibility
What is being tested?
The study aims to understand how brain glucose transport is affected in obese individuals by temporarily raising fatty acid levels using Intralipid. A placebo group will serve as a comparison. The effects on brain metabolism are monitored through magnetic resonance spectroscopy (MRS).See study design
What are the potential side effects?
Intralipid may cause reactions at the infusion site such as redness and pain; allergic reactions including rash and difficulty breathing; and changes in blood fat levels which can affect overall health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is over 30.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through end of study (up to 12 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through end of study (up to 12 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
Change in brain glucose transport capacity

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%

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Non-diabetic, normal weight individuals receiving IntralipidExperimental Treatment1 Intervention
Non-diabetic, normal weight individuals receiving Intralipid. Participants will receive an infusion of Intralipid 20% for 12 hours through an IV (prior to and during scan #2)
Group II: Non-diabetic, normal weight individuals receiving salinePlacebo Group1 Intervention
Non-diabetic, normal weight individuals receiving saline. Participants will receive an infusion of normal saline (1:1 randomization) at 30 ml/hr for 12 hours through an IV (prior to and during scan #2
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

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,778 Total Patients Enrolled
59 Trials studying Obesity
248,108 Patients Enrolled for Obesity
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,576 Total Patients Enrolled
64 Trials studying Obesity
58,014 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,201 Total Patients Enrolled
446 Trials studying Obesity
588,898 Patients Enrolled for Obesity

Media Library

Intralipid, 20% Intravenous Emulsion (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04328337 — Phase 1 & 2
Obesity Research Study Groups: Non-diabetic, normal weight individuals receiving Intralipid, Non-diabetic, normal weight individuals receiving saline
Obesity Clinical Trial 2023: Intralipid, 20% Intravenous Emulsion Highlights & Side Effects. Trial Name: NCT04328337 — Phase 1 & 2
Intralipid, 20% Intravenous Emulsion (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04328337 — Phase 1 & 2

Frequently Asked Questions

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

Does age restriction bar individuals below 70 years old from participating in this research?

"This study is seeking participants aged 18 to 45 years old."

Answered by AI

May I become an enrollee in this investigation?

"Qualified applicants must meet the criteria of being between 18 and 45 years old, as well as having a diagnosis of obesity. This trial has 40 open spots for eligible patients to fill."

Answered by AI

What prior research has been completed regarding the efficacy of Intralipid, 20% Intravenous Emulsion?

"Presently, there are 13 clinical studies underway that focus on the efficacy of Intralipid, 20% Intravenous Emulsion. Of those ongoing trials, 3 have advanced to Phase 3. Although most of these investigations are centered in Boston, Massachusetts, a total of 27 sites across the country are running tests for this medication."

Answered by AI

How many patients are being recruited for participation in this clinical research?

"Affirmative. Information posted on clinicaltrials.gov confirms that this medical trial, which was first advertised on December 8th 2020 is currently recruiting patients. A total of 40 individuals need to be signed up from 1 distinct site."

Answered by AI

What conditions are usually treated with Intralipid, 20% Intravenous Emulsion?

"Intralipid, 20% Intravenous Emulsion is an efficacious treatment for parenteral nutrition, nutritional supplementation and ascorbic acid deficiency."

Answered by AI

Are there any unfilled vacancies for participation in this experiment?

"Indeed, the details on clinicaltrials.gov affirm that this trial is actively recruiting participants. It was first announced on December 8th 2020 and was most recently updated on May 12th 2022. The research team seeks 40 patients from a single site to participate in this study."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Yale School of Medicine
University of North Carolina at Chapel Hill
Other
Clinical and Translational Research Center (CTRC) Burnett-Womack Building (UNC)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Investigating Whether Acute Elevation of Fatty Acid Levels Alters Cerebral Glucose Transport and Metabolism
2020. "Investigating Whether Acute Elevation of Fatty Acid Levels Alters Cerebral Glucose Transport and Metabolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04328337.
~10 spots leftby Jun 2025
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