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Clinical Trial NCT07501403 for Nutrition is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Impact of Protein Formulations on the Stimulation of Muscle Protein Synthesis 20
Impact of Protein Formulations on Postprandial Aminoacidemia and the Stimulation of Resting and Post-exercise Muscle Protein Synthesis in Healthy Adults
- IRB25-1486
- HT9425-25-9-0014 (Other Grant/Funding Number) (DoD)
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OtherSequence A/B | 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. |
OtherSequence B/A | 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. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
FSR | 5-12 Hours post-product consumption |
| Outcome Measure | Measure Description | 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 |
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
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
VitaKey Inc.- United States Department of Defense (DOD)
- Biofortis Clinical Research, Inc.