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

NCT07595575 | Not Yet Recruiting DMC

• 1 other identifier: Pro00093796 Leuvate001
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

The Whole-body Protein Synthesis Response to Protein With Amino Acid or Amino Acids

Keywords

Leuvate; aminoacidemia; glycemia; insulinemia; whole-body protein synthesis

Outcome Measures

Primary Outcomes (1)

• Whole-body protein synthesis

  The rates will change over time.

  5 hours following consumption.

Study Arms (3)

Standard protein dose

ACTIVE COMPARATOR

whole protein

Dietary Supplement: GLP-1

Novel LEUVATE supplement 001

EXPERIMENTAL

suboptimal dose of whole protein with amino acids

Dietary Supplement: GLP-1

Novel LEUVATE supplement 002

EXPERIMENTAL

amino acids

Dietary Supplement: GLP-1

Interventions

GLP-1 DIETARY_SUPPLEMENT

Positive control

Standard protein dose

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutraceutical Innovations LLC: lead
• University of Toronto: collaborator
• Queen's University: collaborator
• University of Arkansas: collaborator
• DePaul University: collaborator

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Glucagon-Like Peptide 1

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Daniel A Traylor, Ph.D.

CONTACT

773-325-8191; DanielT@leuvate.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The blood and breath sample analysis will be masked from the study arms.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share