Leuvate001

Not yet recruitingPhase NA

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

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

Lead sponsor

Nutraceutical Innovations LLC

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Estimated enrollment

Study population

Eligibility highlights

•Healthy volunteers

Primary endpoint

•Whole-body protein synthesis

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07595575

Org study IDPro00093796 Leuvate001

Timeline

Milestones

Study first posted2026-05-19actual

Last update posted2026-05-20actual

Study start2026-06-01estimated

Primary completion2026-08-01estimated

Study completion2026-12-01estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who can enroll

Minimum age30 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Whole-body protein synthesis

Time frame:5 hours following consumption.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.