Isoleucine Addition Treatment Effects in a Controlled Diet Study (ISOLATE)

Jean L. Fry

Status: Begins enrollment this month

Conditions: Obesity & Overweight; Metabolic Syndrome (MetS); Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Treatments: Other: Low-isoleucine diet; Dietary Supplement: L-Isoleucine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07329088

108059

P20GM156679 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Isoleucine restriction promotes insulin sensitivity in preclinical models and is a promising strategy for preventing type 2 diabetes. This project aims to identify clinical and molecular changes in skeletal muscle and adipose tissues when adults with obesity switch from a typical American style diet to a plant-based diet low in isoleucine with or without isoleucine repletion.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI ≥ 30
• Meeting at least three metabolic syndrome criteria
• Follow an American style diet

Exclusion criteria

• Type 1 or 2 Diabetes diagnosis
• Medical condition or medication that affects insulin sensitivity, weight, or metabolism
• More than 5% weight change in 3 previous months
• Restrictive dietary pattern
• History of bariatric surgery
• Food allergy more severe than grade 1 on the CoFAR Grading Scale for Systemic Allergic Reactions, Version 3.0
• Allergy to lidocaine.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Isoleucine group

Experimental group

Description:

Participants will be randomized to receive low-isoleucine diet and isoleucine supplement

Treatment:

Dietary Supplement: L-Isoleucine

Other: Low-isoleucine diet

Placebo group

Active Comparator group

Description:

Participants will be randomized to receive low-isoleucine diet and placebo supplement

Treatment:

Other: Low-isoleucine diet