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| Name | Class |
|---|---|
| University of Toronto | OTHER |
| Queen's University | OTHER |
| University of Arkansas | OTHER |
| DePaul University |
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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
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):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard protein dose | Active Comparator | whole protein |
|
| Novel LEUVATE supplement 001 | Experimental | suboptimal dose of whole protein with amino acids |
|
| Novel LEUVATE supplement 002 | Experimental | amino acids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP-1 | Dietary Supplement | Positive control |
| |
| GLP-1 |
| Measure | Description | Time Frame |
|---|---|---|
| Whole-body protein synthesis | The rates will change over time. | 5 hours following consumption. |
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Inclusion Criteria: Be between the ages of 30 and 65 years (inclusive)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel A Traylor, Ph.D. | Contact | 773-325-8191 | DanielT@leuvate.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35609328 | Background | Mazzulla M, Hodson N, West DWD, Kumbhare DA, Moore DR. A non-invasive 13CO2 breath test detects differences in anabolic sensitivity with feeding and heavy resistance exercise in healthy young males: a randomized control trial. Appl Physiol Nutr Metab. 2022 Aug 1;47(8):860-870. doi: 10.1139/apnm-2021-0808. Epub 2022 May 24. | |
| 41321015 |
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The data is owned by a private business.
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| OTHER |
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The blood and breath sample analysis will be masked from the study arms.
| Dietary Supplement |
Experimental Leuvate 001 |
|
| GLP-1 | Dietary Supplement | Experimental Leuvate 002 |
|
| Aguilera JA, Tinline-Goodfellow CT, Lees MJ, Kortebi I, West DWD, Abou Sawan S, Sharma M, Bashir R, Barnes TM, Ulanov AV, Burd NA, Moore DR. Dileucine-supplemented essential amino acids support whole-body anabolism after resistance exercise and serum-stimulated cell-based anabolism. J Int Soc Sports Nutr. 2025 Dec 31;22(1):2590090. doi: 10.1080/15502783.2025.2590090. Epub 2025 Nov 30. |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| ID | Term |
|---|---|
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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