The Effects of LEUVATE on Glycemia, Insulinemia, Aminoacidemia, and Protein Synthesis in GLP-1 RA-treated Adults (Leuvate001)
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
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Daniel A Traylor, Ph.D.
- Numéro de téléphone: 773-325-8191
- E-mail: DanielT@leuvate.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Standard protein dose
whole protein
|
Positive control
Experimental Leuvate 001
Experimental Leuvate 002
|
|
Expérimental: Novel LEUVATE supplement 001
suboptimal dose of whole protein with amino acids
|
Positive control
Experimental Leuvate 001
Experimental Leuvate 002
|
|
Expérimental: Novel LEUVATE supplement 002
amino acids
|
Positive control
Experimental Leuvate 001
Experimental Leuvate 002
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Whole-body protein synthesis
Délai: 5 hours following consumption.
|
The rates will change over time.
|
5 hours following consumption.
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00093796 Leuvate001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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