NutritionNCT07501403
Impact of Protein Formulations on the Stimulation of Muscle Protein Synthesis
A study of Nutrition, run by VitaKey Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jul 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Nutrition
- Being tested
- Control Protein then Extended Release Nutritional Protein, Extended Release Protein then Control Nutritional Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Protein then Extended Release Nutritional ProteinOther
Participants will consume a beverage with standard nutritional protein. Washout. Then participants will consume a beverage with extended release nutritional protein.
Extended Release Protein then Control Nutritional ProteinOther
Participants will consume a beverage with extended release nutritional protein. Washout. Then, participants will consume a beverage with control nutritional protein.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A/B | Other | Not described Receives: Other: Control Protein then Extended Release Nutritional Protein |
| Sequence B/A | Other | Not described Receives: Other: Extended Release Protein then Control Nutritional Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSR
Measured: 5-12 Hours post-product consumption
Secondary outcomes (47)
FSR
Measured: 0-12 Hours post-product consumption
FSR
Measured: 0-5 Hours post-product consumption
Total Amino Acid 0-5 h incremental area-under-the-curve (iAUC)
Measured: 0-5 hours post-product consumption
Essential Amino Acid 0-5 h incremental area-under-the-curve (iAUC)
Measured: 0-5 Hours post-product consumption
Branch Chain Amino Acid 0-5 h incremental area-under-the-curve (iAUC)
Measured: 0-5 Hours post-production consumption
Plasma Leucine 0-5 h incremental area-under-the-curve (iAUC)
Measured: 0-5 Hours post-product consumption
Total Amino Acid 5-12 h incremental area-under-the-curve
Measured: 5-12 Hours post-product consumption
Essential Amino Acid 5-12 h incremental area-under-the-curve
Measured: 5-12 Hours post-product consumption
Branch Chain Amino Acid 5-12 h incremental area-under-the-curve
Measured: 5-12 Hours post-product consumption
Plasma Leucine 5-12 h incremental area-under-the-curve
Measured: 5-12 Hours post-product consumption
Total Amino Acid 0-12 h incremental area-under-the-curve
Measured: 0-12 Hours post-product consumption
Essential Amino Acid 0-12 h incremental area-under-the-curve
Measured: 0-12 Hours post-product consumption
Branch Chain Amino Acid 0-12 h incremental area-under-the-curve
Measured: 0-12 Hours post product consumption
Plasma Leucine 0-12 h incremental area-under-the-curve
Measured: 0-12 Hours post-product consumption
Total Amino Acid Maximum concentration (CMAX)
Measured: 0-12 hours post product consumption
Essential Amino Acid Maximum concentration (CMAX)
Measured: 0-12 Hours post-product consumption
Branch Chain Amino Acid Maximum concentration (CMAX)
Measured: 0-12 Hours post-product consumption
Plasma Leucine Maximum concentration (CMAX)
Measured: 0-12 Hours post-product consumption
Total Amino Acid Time to peak concentration (TTP)
Measured: 0-12 Hours post-product consumption
Branch Chain Amino Acid Time to peak concentration (TTP)
Measured: 0-12 Hours post product consumption
Plasma Leucine Time to peak concentration (TTP)
Measured: 0-12 Hours post-product consumption
Plasma glucose 0-5 h incremental area-under-the-curve
Measured: 0-5 Hours post-product consumption
Plasma insulin 0-5 h incremental area-under-the-curve
Measured: 0-5 Hours post-product consumption
Plasma glucose 5-12 h incremental area-under-the-curve
Measured: 5-12 Hours post product consumption
Plasma insulin 5-12 h incremental area-under-the-curve
Measured: 5-12 Hours post-product consumption
Plasma glucose 0-12 h incremental area-under-the-curve (iAUC)
Measured: 0-12 Hours post-product consumption
Plasma insulin 0-12 h incremental area-under-the-curve (iAUC)
Measured: 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)
Measured: 0-12 Hours post-product consumption
Positive incremental AUC5-12h composite {[desire to eat + hunger + (100 - fullness) + prospective consumption]/4} appetite scores
Measured: 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)
Measured: 5-12 Hours post-product consumption
Individual Hunger appetite scores 5-12 h post-product
Measured: 5-12 Hours post-product consumption
Desire to eat individual appetite scores 5-12 h post-product
Measured: 5-12 hours post- product consumption
Fullness individual appetite scores 5-12 h post-product.
Measured: 5-12 hours post-product consumption
Fullness individual appetite scores 5-12 h post-product
Measured: 5-12 hours post-product consumption
Prospective food consumption individual appetite scores 5-12 h post-product
Measured: 5-12 hours post-product consumption
Net incremental total amino acid at 12h
Measured: 12 hours post-product consumption
Net incremental essential amino acid at 12h
Measured: 12 hours post-product consumption
Net incremental branch chain amino acid at 12h
Measured: 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)
Measured: 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)
Measured: 0-12 hours post-product consumption
Individual satisfaction scores 5-12 h post-product
Measured: 5-12 hours post-product consumption
Individual desire to snack scores 5-12 h post-product
Measured: 5-12 hours post-product consumption
Individual food craving scores 5-12 h post-product
Measured: 5-12 hours post-product consumption
Individual sweet craving scores 5-12 h post-product
Measured: 5-12 hours post-product consumption
Individual salty cravings scores 5-12 h post-product
Measured: 5-12 hours post-product consumption
Individual savory scores 5-12 h post-product
Measured: 5-12 hours post-product consumption
Individual fatty craving scores 5-12 h post-product
Measured: 5-12 hours post-product consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VitaKey Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Biofortis Clinical Research, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501403
- Sponsor's protocol ID
- IRB25-1486
- Other IDs
- HT9425-25-9-0014
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Protein Formulations on Postprandial Aminoacidemia and the Stimulation of Resting and Post-exercise Muscle Protein Synthesis in Healthy Adults
- ClinicalTrials.gov ID
- NCT07501403
- Acronym / sponsor ID
- IRB25-1486
- Conditions
- Nutrition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- VitaKey Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Biofortis Clinical Research, Inc.
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 30 Mar 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A/B | Other | Other: Control Protein then Extended Release Nutritional Protein |
| Sequence B/A | Other | Other: Extended Release Protein then Control Nutritional Protein |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Control Protein then Extended Release Nutritional ProteinParticipants will consume a beverage with standard nutritional protein. Washout. Then participants will consume a beverage with extended release nutritional protein. | Other | Sequence A/B |
| Extended Release Protein then Control Nutritional ProteinParticipants will consume a beverage with extended release nutritional protein. Washout. Then, participants will consume a beverage with control nutritional protein. | Other | Sequence B/A |
Primary outcome
FSR
Time frame: 5-12 Hours post-product consumption
47 secondary outcomes
FSR
Time frame: 0-12 Hours post-product consumption
FSR
Time frame: 0-5 Hours post-product consumption
Total Amino Acid 0-5 h incremental area-under-the-curve (iAUC)
Time frame: 0-5 hours post-product consumption
Essential Amino Acid 0-5 h incremental area-under-the-curve (iAUC)
Time frame: 0-5 Hours post-product consumption
Branch Chain Amino Acid 0-5 h incremental area-under-the-curve (iAUC)
Time frame: 0-5 Hours post-production consumption
Plasma Leucine 0-5 h incremental area-under-the-curve (iAUC)
Time frame: 0-5 Hours post-product consumption
Total Amino Acid 5-12 h incremental area-under-the-curve
Time frame: 5-12 Hours post-product consumption
Essential Amino Acid 5-12 h incremental area-under-the-curve
Time frame: 5-12 Hours post-product consumption
Branch Chain Amino Acid 5-12 h incremental area-under-the-curve
Time frame: 5-12 Hours post-product consumption
Plasma Leucine 5-12 h incremental area-under-the-curve
Time frame: 5-12 Hours post-product consumption
Total Amino Acid 0-12 h incremental area-under-the-curve
Time frame: 0-12 Hours post-product consumption
Essential Amino Acid 0-12 h incremental area-under-the-curve
Time frame: 0-12 Hours post-product consumption
Branch Chain Amino Acid 0-12 h incremental area-under-the-curve
Time frame: 0-12 Hours post product consumption
Plasma Leucine 0-12 h incremental area-under-the-curve
Time frame: 0-12 Hours post-product consumption
Total Amino Acid Maximum concentration (CMAX)
Time frame: 0-12 hours post product consumption
Essential Amino Acid Maximum concentration (CMAX)
Time frame: 0-12 Hours post-product consumption
Branch Chain Amino Acid Maximum concentration (CMAX)
Time frame: 0-12 Hours post-product consumption
Plasma Leucine Maximum concentration (CMAX)
Time frame: 0-12 Hours post-product consumption
Total Amino Acid Time to peak concentration (TTP)
Time frame: 0-12 Hours post-product consumption
Branch Chain Amino Acid Time to peak concentration (TTP)
Time frame: 0-12 Hours post product consumption
Plasma Leucine Time to peak concentration (TTP)
Time frame: 0-12 Hours post-product consumption
Plasma glucose 0-5 h incremental area-under-the-curve
Time frame: 0-5 Hours post-product consumption
Plasma insulin 0-5 h incremental area-under-the-curve
Time frame: 0-5 Hours post-product consumption
Plasma glucose 5-12 h incremental area-under-the-curve
Time frame: 5-12 Hours post product consumption
Plasma insulin 5-12 h incremental area-under-the-curve
Time frame: 5-12 Hours post-product consumption
Plasma glucose 0-12 h incremental area-under-the-curve (iAUC)
Time frame: 0-12 Hours post-product consumption
Plasma insulin 0-12 h incremental area-under-the-curve (iAUC)
Time frame: 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)
Time frame: 0-12 Hours post-product consumption
Positive incremental AUC5-12h composite {[desire to eat + hunger + (100 - fullness) + prospective consumption]/4} appetite scores
Time frame: 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)
Time frame: 5-12 Hours post-product consumption
Individual Hunger appetite scores 5-12 h post-product
Time frame: 5-12 Hours post-product consumption
Desire to eat individual appetite scores 5-12 h post-product
Time frame: 5-12 hours post- product consumption
Fullness individual appetite scores 5-12 h post-product.
Time frame: 5-12 hours post-product consumption
Fullness individual appetite scores 5-12 h post-product
Time frame: 5-12 hours post-product consumption
Prospective food consumption individual appetite scores 5-12 h post-product
Time frame: 5-12 hours post-product consumption
Net incremental total amino acid at 12h
Time frame: 12 hours post-product consumption
Net incremental essential amino acid at 12h
Time frame: 12 hours post-product consumption
Net incremental branch chain amino acid at 12h
Time frame: 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)
Time frame: 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)
Time frame: 0-12 hours post-product consumption
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 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study of Nutrition, run by VitaKey Inc..
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 2 inclusion and 5 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 30 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FSR (time frame: 5-12 Hours post-product consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026.