The Effects of LEUVATE on Glycemia, Insulinemia, Aminoacidemia, and Protein Synthesis in GLP-1 RA-treated Adults (Leuvate001)

May 18, 2026 updated by: Daniel A. Traylor, Nutraceutical Innovations LLC

Investigating the Effectiveness of Novel Amino Acid-enriched Supplement Beverages to Determine Post-ingestion Glycemia, Insulinemia, Aminoacidemia, and Whole-body Protein Synthesis Rates in Adults Prescribed GLP-1 RA Drugs

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Participant Characteristics: DOB, body weight, height, biological sex, and clinical information, which are: 1. Time on GLP1 RA drugs, what kind of GLP1 RA drug, any other drugs or treatments, any vitamins, HbA1c level, C-reactive protein levels, and fasting glucose levels will be measured at baseline. Additionally, a medical screening questionnaire will be provided.

Blood Sampling (experimental): Blood sampling will be conducted while the participant lies comfortably on a medical examination bed. A flexible catheter will be inserted into a vein in the forearm using a small intravenous needle and will remain patent with a saline flush.

Breath Sampling: Breath sampling will take place while the participant sits comfortably on a medical examination bed. They will exhale a full breath into a plastic bag, and the breath will be collected for analysis.

Per-Procedural Conditions (experimental):

  • Participants will be asked to maintain consistent physical activity and nutritional intake for two days before each trial.
  • Blood samples will be analyzed for amino acids, blood glucose, and insulin levels.
  • Breath samples will be analyzed to measure whole-body protein synthesis rates.

The study products will each contain a safe, stable amino acid isotope tracer and will be drunk with water from a shaker bottle. Experimental drink formulas are listed below: 1.

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: Be between the ages of 30 and 65 years (inclusive)

  • Healthy
  • With type 2 diabetes, pre-diabetes, obesity, overweight, or previously diabetic, obese, or overweight
  • Need to be on GLP-1 RA medication for no more than six months after starting the prescription.
  • Need to show a recent record of weight loss of 1-5 kilograms (2-11 pounds) due to the use of the GLP1-RA medication.

Exclusion Criteria:

  • Pregnant
  • Smoke and use any tobacco products
  • A history of neuromuscular disorders or diseases that cause muscle and/or bone wasting
  • The chronic use of medications known to impact protein metabolism, such as corticosteroids, non-steroidal anti-inflammatory drugs, or prescription-strength acne treatments
  • Smoker
  • Excessive alcohol consumption (more than 21 units of alcohol / week; 1 unit of alcohol is approximately 25 mL of spirits (40% alcohol), 250 mL of beer (4% alcohol) or 75 mL of wine (13% alcohol)
  • Have health problems such as: renal or gastrointestinal disorders, metabolic disease, heart disease, vascular disease, rheumatoid arthritis, poor lung function, uncontrolled blood pressure, dizziness, thyroid problems, or any other health conditions for which you are being treated that might put you at risk for this study
  • Have a dairy protein allergy
  • Participation in another nutrition or exercise research study
  • Do not understand English or have a condition the PI believes would interfere with a participants' ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put someone at undue risk
  • Use of medications known to affect protein metabolism (i.e. corticosteroids, or prescription strength acne medications)
  • Consuming a vegan diet
  • Use of an investigational drug product or nutraceutical within the last 30 days
  • Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigators, would compromise the ability to comply with the study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard protein dose
whole protein
Dietary supplement: GLP-1
Positive control
Dietary supplement: GLP-1
Experimental Leuvate 001
Dietary supplement: GLP-1
Experimental Leuvate 002
Experimental: Novel LEUVATE supplement 001
suboptimal dose of whole protein with amino acids
Dietary supplement: GLP-1
Positive control
Dietary supplement: GLP-1
Experimental Leuvate 001
Dietary supplement: GLP-1
Experimental Leuvate 002
Experimental: Novel LEUVATE supplement 002
amino acids
Dietary supplement: GLP-1
Positive control
Dietary supplement: GLP-1
Experimental Leuvate 001
Dietary supplement: GLP-1
Experimental Leuvate 002

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole-body protein synthesis
Time Frame: 5 hours following consumption.
The rates will change over time.
5 hours following consumption.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutraceutical Innovations LLC

Collaborators

University of Toronto
Queen's University
University of Arkansas
DePaul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 9, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00093796 Leuvate001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data is owned by a private business.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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