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

N/ANot Yet RecruitingNCT07595575

Nutraceutical Innovations LLC8 enrolled

Overview

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): * 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

Allocation

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Central Contacts