Clinical Trial

The Effects of LEUVATE on Glycemia, Insulinemia, Aminoacidemia, and Protein Synthesis in GLP-1 RA-treated Adults

Study acronym: Leuvate001
Not Yet Recruiting
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Record status
This record was last updated May 20, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
GLP-1 receptor agonists have recently emerged as highly effective pharmacological agents for promoting weight loss and improving metabolic health. Despite their benefits, weight regain frequently occurs once pharmacotherapy is discontinued, highlighting the limitations of medication alone. Growing evidence suggests that combining GLP-1 therapy with structured exercise and dietary interventions may yield synergistic effects, supporting greater long-term weight maintenance and preservation of lean body mass. This study aims to investigate the effects of a leucine-enriched multi-nutrient study product on blood levels of amino acids, glucose, and insulin, and how this study product stimulates whole-body protein growth rates. The study product ingredients are within safe and tolerable limits in humans. Understanding the effects of different multi-ingredient supplements on changes in blood amino acids, glucose, insulin, and whole-body protein synthesis will provide valuable insights for recommending appropriate supplement usage, particularly for individuals on GLP-1 drugs
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-14.
Trial Details
NCT Number NCT07595575
Lead Sponsor Nutraceutical Innovations LLC
Collaborators: University of Toronto, Queen's University, University of Arkansas, DePaul University
Conditions The Whole-body Protein Synthesis Response to Protein With Amino Acid or Amino Acids
Enrollment 8 participants
Start Date 2026-06-01
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-20