Impact of Protein Formulations on the Stimulation of Muscle Protein Synthesis

NCT07501403 | Not Yet Recruiting

• 2 other identifiers: IRB25-1486HT9425-25-9-0014
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall objective of this study is to determine the effects of ingesting protein that slowly releases amino acids into the blood vs. a control product on how our muscles regulate the synthesis of new proteins, termed muscle protein synthesis (MPS), in healthy volunteers.

Conditions

Nutrition

Outcome Measures

Primary Outcomes (1)

• FSR

  5-12 Hours post-product consumption

Secondary Outcomes (47)

• FSR

  0-12 Hours post-product consumption

• FSR

  0-5 Hours post-product consumption

• Total Amino Acid 0-5 h incremental area-under-the-curve (iAUC)

  0-5 hours post-product consumption

• Essential Amino Acid 0-5 h incremental area-under-the-curve (iAUC)

  0-5 Hours post-product consumption

• Branch Chain Amino Acid 0-5 h incremental area-under-the-curve (iAUC)

  0-5 Hours post-production consumption

Study Arms (2)

Sequence A/B

OTHER

Other: Control Protein then Extended Release Nutritional Protein

Sequence B/A

OTHER

Other: Extended Release Protein then Control Nutritional Protein

Interventions

Control Protein then Extended Release Nutritional Protein OTHER

Participants will consume a beverage with standard nutritional protein. Washout. Then participants will consume a beverage with extended release nutritional protein.

Sequence A/B

Extended Release Protein then Control Nutritional Protein OTHER

Participants will consume a beverage with extended release nutritional protein. Washout. Then, participants will consume a beverage with control nutritional protein.

Sequence B/A

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Age 19-40 years of age, inclusive • 2. Pre-menopausal 3. Recreationally-active 4. No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history 5. Non-user of tobacco or nicotine products (e.g.
• cigarette smoking, vaping, chewing tobacco) within 12 months of Visit 1, with no plans to begin use during the study period 6. BMI 18.5-29.9 kg/m2 7. Willing to adhere to all study procedures and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator

You may not qualify if:

• \. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period 2. Female with irregular menstrual cycles (i.e., \<21 day or \>35 day cycle) 3. Participation in previous research using a 13C stable isotope tracer 4. Participation in other ongoing research that interferes with this study (e.g., conflicting diet, activity interventions, etc.) 5. History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, metabolic, gastrointestinal motility or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator 6. Currently in a habitual exercise training program (≥ 3 days/week of structured exercise) or plans to initiate an exercise training program during the study period 7. Self-report of unstable weight (variation \>5% of bodyweight in last 6 months prior to visit 1) 8. Phenylketonuria 9. Previously hospitalized for COVID-19 without a cardiovascular workup screening for cardiovascular issues post-infection 10. Recovering from COVID-19 infection within the preceding 10 days from visits 1 11. Uncontrolled hypertension (systolic blood pressure ≥140mm Hg or diastolic blood pressure ≥90mm Hg) as defined by the blood pressure measured at visit 1.
• Stable use of hypertension medication is allowed (defined as no change in medication regimen ≤ 90 days of visit 1) 12. Any signs or symptoms of active infection of clinical relevance (e.g. urinary tract or respiratory) within 5 days prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment has been completed at least 5 days prior to testing 13. History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer 14. History of any major trauma or major surgical event within 2 months of visit 1 15. Self-report history of extreme dietary behavior (e.g., vegetarian diet, keto diet, anorexia nervosa, bulimia nervosa, binge eating) 16. Taking medications affecting gastrointestinal motility 17. Liver medication use 18. Recent use of antihyperglycemic (e.g. metformin, insulin, DPP 4 inhibitors, SGLT-2 inhibitors, GIP agonist, Pioglitazone, or Sulfonylureas) or GLP-1 analogue (e.g., Ozempic or Wegovy semaglutide, Mounjaro trizapatide) prescription medications within 6 months of visit 1 19. Steroid use within 30 days of visit 1 and throughout the study period 20. Unstable use of any prescription medication, where stable use is defined as no change in dose or medication type within 90 days of visit 1 21. Recent history of (within 12 months of screening; visit 1) or strong potential for alcohol or substance abuse.
• Alcohol abuse is defined as \> 14 drinks per week (1 drink = 12 oz beer, 5 oz wine or 1 ½ oz distilled spirits) 22. Consumption of ergogenic-levels of dietary supplements that may affect muscle mass (e.g., creatine, HMB), insulin-like substances, or anabolic/catabolic pro-hormones (e.g., DHEA) within 6 weeks prior to participation 23. Consumption of thyroid, androgenic, or other medications known to affect endocrine function 24.
• Consumption of medications known to affect protein metabolism (e.g., prescription-strength corticosteroids, non-steroidal anti-inflammatories, or acne medication) 25. Antibiotic use within 30 days of visit 1 and throughout the study period 26. Exposed to any non-registered drug product within 30 days of visit 1 27. Habitual users (i.e., daily or almost daily) of marijuana and hemp products, including CBD products. Occasional use (e.g. couple times a month) within 12 months of visit 1 is allowed but requires at least a 14 day washout prior to visit 1 and the participant must be willing to refrain from use during the study (sleep aids and topical lotions/creams are allowed) 28. Allergy or hypersensitivity to local anesthetics, latex, or adhesives (bandages, medical tape, etc.) 29. Excess scarring after injury, including predisposition to hypertrophic scarring or keloid formation 30. History of excess bleeding after cut 31. Known allergy or sensitivity to any ingredients or potential allergens contained in the study product or standard meals 32. Physical activity limitations 33. Self-report history of fainting during routine blood draws or upon sight of blood 34.
• Chronic or frequent dizziness or fainting and arm or leg weakness/numbness 35. Self-report of blood donation totaling between 101-449mL of blood within 30 days prior to visit 1 or a blood donation of ≥ 450 mL within 56 days prior to visit 1, or plasma donations within 48 hours of visit 1. As well as any plans to donate blood or plasma during the study period 36. Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk

Sponsors & Collaborators

• Biofortis Clinical Research, Inc.: collaborator
• VitaKey Inc.: lead
• United States Department of Defense (DOD): collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03