L-Isoleucine for Obesity

(ISOLATE Trial)

JF
KA
Overseen ByKayla Anderson, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary purpose of this study is to determine whether isoleucine repletion attenuates increases in insulin sensitivity typically observed when people with obesity follow a healthy, low-isoleucine diet.

Who Is on the Research Team?

JF

Jean Fry, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

Inclusion Criteria

My BMI is 30 or higher.
Follow an American style diet
I meet three or more criteria for metabolic syndrome.

Exclusion Criteria

More than 5% weight change in 3 previous months
I have been diagnosed with Type 1 or Type 2 diabetes.
Restrictive dietary pattern
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants transition from a typical American diet to a plant-based diet low in isoleucine

1 week

Treatment

Participants receive a low-isoleucine diet with either isoleucine supplementation or placebo

4 weeks

Follow-up

Participants are monitored for changes in insulin sensitivity and other metabolic markers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • L-Isoleucine

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Isoleucine groupExperimental Treatment2 Interventions
Group II: Placebo groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jean L. Fry

Lead Sponsor

Trials
1
Recruited
6+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials
315
Recruited
251,000+