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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка GLP-1
  Positive control
• Пищевая добавка GLP-1
  Experimental Leuvate 001
• Пищевая добавка GLP-1
  Experimental Leuvate 002

Первичные конечные точки

• Whole-body protein synthesis [Срок оценки: 5 hours following consumption.]

Критерии участия

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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 35609328
• 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. PMID 41321015

Идентификаторы

NCT: NCT07595575 · Pro00093796 Leuvate001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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