The Whole-body Protein Synthesis Response to Protein With Amino Acid or Amino AcidsLeuvate001NCT07595575
The Effects of LEUVATE on Glycemia, Insulinemia, Aminoacidemia, and Protein Synthesis in GLP-1 RA-treated Adults
A study testing GLP-1 in people with The Whole-body Protein Synthesis Response to Protein With Amino Acid or Amino Acids, run by Nutraceutical Innovations LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- The Whole-body Protein Synthesis Response to Protein With Amino Acid or Amino Acids
- What is being tested?
- GLP-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the detailed description
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.
- Being tested
- GLP-1
- Keywords
- Leuvate, aminoacidemia, glycemia, insulinemia, whole-body protein synthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1Dietary supplement
Positive control
GLP-1Dietary supplement
Experimental Leuvate 001
GLP-1Dietary supplement
Experimental Leuvate 002
| Study group | Role | What they receive |
|---|---|---|
| Standard protein dose | Active comparator | whole protein Receives: Dietary Supplement: GLP-1 |
| Novel LEUVATE supplement 001 | Experimental | suboptimal dose of whole protein with amino acids Receives: Dietary Supplement: GLP-1 |
| Novel LEUVATE supplement 002 | Experimental | amino acids Receives: Dietary Supplement: GLP-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body protein synthesis
The rates will change over time.
Measured: 5 hours following consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for The Whole-body Protein Synthesis Response to Protein With Amino Acid or Amino AcidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutraceutical Innovations LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Toronto, Queen's University, University of Arkansas, DePaul University
- Responsible party
- Principal investigator, Daniel A. Traylor, Nutraceutical Innovations LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595575
- Sponsor's protocol ID
- Pro00093796 Leuvate001
- Acronym
- Leuvate001
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is owned by a private business.
Publications
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.
PubMed 35609328Aguilera 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.
PubMed 41321015
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07595575
- Acronym / sponsor ID
- Leuvate001 / Pro00093796 Leuvate001
- Keywords
- Leuvate, aminoacidemia, glycemia, insulinemia, whole-body protein synthesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Nutraceutical Innovations LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Toronto, Queen's University, University of Arkansas, DePaul University
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard protein dose | Active comparator | Dietary Supplement: GLP-1whole protein |
| Novel LEUVATE supplement 001 | Experimental | Dietary Supplement: GLP-1suboptimal dose of whole protein with amino acids |
| Novel LEUVATE supplement 002 | Experimental | Dietary Supplement: GLP-1amino acids |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1Positive control | Dietary supplement | Standard protein dose |
| GLP-1Experimental Leuvate 001 | Dietary supplement | Novel LEUVATE supplement 001 |
| GLP-1Experimental Leuvate 002 | Dietary supplement | Novel LEUVATE supplement 002 |
Primary outcome
Whole-body protein synthesis
Time frame: 5 hours following consumption.
The rates will change over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 35609328Mazzulla 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.
- Background: PubMed 41321015Aguilera 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.
- Individual participant dataSharing planned: No. The data is owned by a private business.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1 in people with The Whole-body Protein Synthesis Response to Protein With Amino Acid or Amino Acids, run by Nutraceutical Innovations LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel A Traylor, Ph.D. (773-325-8191, DanielT@leuvate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-body protein synthesis (time frame: 5 hours following consumption.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07595575, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.