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Isoleucine Addition Treatment Effects in a Controlled Diet Study

NCT07329088 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Jean L. Fry

    lead OTHER

Principal Investigators

  • Jean Fry, PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-04
Primary Completion
2029-01-31
Completion
2029-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07329088 on ClinicalTrials.gov