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NOT YET RECRUITING
NCT07329088
NA

Isoleucine Addition Treatment Effects in a Controlled Diet Study

Sponsor: Jean L. Fry

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-05-04

Completion Date

2029-01-31

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

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.

Locations (1)

University of Kentucky

Lexington, Kentucky, United States