NCT07329088

Isoleucine Addition Treatment Effects in a Controlled Diet Study

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jean L. Fry · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
• Metabolic Syndrome (MetS)
• Obesity & Overweight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L-Isoleucine	Participants will follow a habitual American style diet. All participants transition to a healthy, low-isoleucine diet the study team provides, but only the isoleucine group receives isoleucine supplements to replete the overall diet to typical intake levels.
OTHER	Low-isoleucine diet	Healthy, weight-maintaining, low-isoleucine meals and snacks will be provided directly to participants for 4 weeks. Diets are formulated by registered dietitians to meet energy, protein, and amino-acid requirements while minimizing weight change; target macronutrient distribution ≈ 10% protein / 60% carbohydrate / 30% fat38. Isoleucine content will meet minimum needs of 23 mg/kg.

Timeline

• Start date: 2026-05-04
• Primary completion: 2029-01-31
• Completion: 2029-01-31
• First posted: 2026-01-09
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States