Impact of Protein Formulations on the Stimulation of Muscle Protein Synthesis

Impact of Protein Formulations on Postprandial Aminoacidemia and the Stimulation of Resting and Post-exercise Muscle Protein Synthesis in Healthy Adults

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nutrition
• Intervention / Treatment: Other: Control Protein then Extended Release Nutritional Protein; Other: Extended Release Protein then Control Nutritional Protein

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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

Exclusion Criteria:

1. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sequence A/B	Other: Control Protein then Extended Release Nutritional Protein; Participants will consume a beverage with standard nutritional protein. Washout. Then participants will consume a beverage with extended release nutritional protein.
Other: Sequence B/A	Other: Extended Release Protein then Control Nutritional Protein; Participants will consume a beverage with extended release nutritional protein. Washout. Then, participants will consume a beverage with control nutritional protein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FSR	5-12 Hours post-product consumption

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Plasma Leucine 0-5 h incremental area-under-the-curve (iAUC)	0-5 Hours post-product consumption
Total Amino Acid 5-12 h incremental area-under-the-curve	5-12 Hours post-product consumption
Essential Amino Acid 5-12 h incremental area-under-the-curve	5-12 Hours post-product consumption
Branch Chain Amino Acid 5-12 h incremental area-under-the-curve	5-12 Hours post-product consumption
Plasma Leucine 5-12 h incremental area-under-the-curve	5-12 Hours post-product consumption
Total Amino Acid 0-12 h incremental area-under-the-curve	0-12 Hours post-product consumption
Essential Amino Acid 0-12 h incremental area-under-the-curve	0-12 Hours post-product consumption
Branch Chain Amino Acid 0-12 h incremental area-under-the-curve	0-12 Hours post product consumption
Plasma Leucine 0-12 h incremental area-under-the-curve	0-12 Hours post-product consumption
Total Amino Acid Maximum concentration (CMAX)	0-12 hours post product consumption
Essential Amino Acid Maximum concentration (CMAX)	0-12 Hours post-product consumption
Branch Chain Amino Acid Maximum concentration (CMAX)	0-12 Hours post-product consumption
Plasma Leucine Maximum concentration (CMAX)	0-12 Hours post-product consumption
Total Amino Acid Time to peak concentration (TTP)	0-12 Hours post-product consumption
Branch Chain Amino Acid Time to peak concentration (TTP)	0-12 Hours post product consumption
Plasma Leucine Time to peak concentration (TTP)	0-12 Hours post-product consumption
Plasma glucose 0-5 h incremental area-under-the-curve	0-5 Hours post-product consumption
Plasma insulin 0-5 h incremental area-under-the-curve	0-5 Hours post-product consumption
Plasma glucose 5-12 h incremental area-under-the-curve	5-12 Hours post product consumption
Plasma insulin 5-12 h incremental area-under-the-curve	5-12 Hours post-product consumption
Plasma glucose 0-12 h incremental area-under-the-curve (iAUC)	0-12 Hours post-product consumption
Plasma insulin 0-12 h incremental area-under-the-curve (iAUC)	0-12 Hours post-product consumption
Maximum postprandial baseline-adjusted GI VAS scores over the 12 h in-clinic period (Overall abdominal symptoms, Abdominal bloating, Abdominal pain, Flatulence, Burping, Stomach rumbling, Nausea, Fatigue)	0-12 Hours post-product consumption
Positive incremental AUC5-12h composite {[desire to eat + hunger + (100 - fullness) + prospective consumption]/4} appetite scores	5-12 Hours post-product consumption
Positive incremental AUC5-12h food craving scores 5-12 h post-product: (Satisfaction, Thirst, Desire to snack, Food cravings, Sweet cravings, Salty cravings, Savory cravings, Fatty cravings)	5-12 Hours post-product consumption
Individual Hunger appetite scores 5-12 h post-product	5-12 Hours post-product consumption
Desire to eat individual appetite scores 5-12 h post-product	5-12 hours post- product consumption
Fullness individual appetite scores 5-12 h post-product.	5-12 hours post-product consumption
Fullness individual appetite scores 5-12 h post-product	5-12 hours post-product consumption
Prospective food consumption individual appetite scores 5-12 h post-product	5-12 hours post-product consumption
Net incremental total amino acid at 12h	12 hours post-product consumption
Net incremental essential amino acid at 12h	12 hours post-product consumption
Net incremental branch chain amino acid at 12h	12 hours post-product consumption
Net incremental AUC postprandial baseline-adjusted GI VAS scores over the 5-12 h in-clinic period (Overall abdominal symptoms, Abdominal bloating, Abdominal pain, Flatulence, Burping, Stomach rumbling, Nausea, Fatigue)	5-12 hours post-product consumption
Net incremental AUC postprandial baseline-adjusted GI VAS scores over the 12 h in-clinic period (Overall abdominal symptoms, Abdominal bloating, Abdominal pain, Flatulence, Burping, Stomach rumbling, Nausea, Fatigue)	0-12 hours post-product consumption
Individual satisfaction scores 5-12 h post-product	5-12 hours post-product consumption
Individual desire to snack scores 5-12 h post-product	5-12 hours post-product consumption
Individual food craving scores 5-12 h post-product	5-12 hours post-product consumption
Individual sweet craving scores 5-12 h post-product	5-12 hours post-product consumption
Individual salty cravings scores 5-12 h post-product	5-12 hours post-product consumption
Individual savory scores 5-12 h post-product	5-12 hours post-product consumption
Individual fatty craving scores 5-12 h post-product	5-12 hours post-product consumption

Collaborators and Investigators

• Sponsor: VitaKey Inc.
• Collaborators: Biofortis Clinical Research, Inc.; United States Department of Defense (DOD)

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB25-1486; HT9425-25-9-0014 (Other Grant/Funding Number: DoD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No