Gastrointestinal TolerabilityNCT07293091
Assessing the Appearance of Amino Acids in Circulation Following Consumption of Protein Beverages
A study testing Protein Powder in people with Gastrointestinal Tolerability and Appetite, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
Trial summary
The objective of this study is to compare the appearance of amino acids in circulation following consumption of two protein beverages in adults. Secondary objectives of this study are to assess changes in gastrointestinal tolerability, glycemia, markers of subjective and physiological appetite, and nausea. Read more about this study
- Who is it for?
- Ages 25 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerability, Appetite, Amino Acids
- What is being tested?
- Protein Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2025to 3 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Male or female, between 25 and 54 years of age.
- 2. Individual has a body mass index (BMI) of 22.5 to 32.5 kg/m2. Only 5 participants will have a BMI of 30 to 32.5 kg/m2.
- 3. Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
- 4. Individual is willing and able to undergo the scheduled study procedures.
- 5. Individual is willing to maintain usual physical activity level for the duration of the study and not to engage in vigorous physical activity for at least 24 hours prior to each clinic visit.
- 6. Individual is willing to abstain from alcohol consumption for at least 24 hours prior to each clinic visit.
- 7. Individual understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- 1. Individual has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
- 2. Individual has poor venous access and is not a good candidate for serial blood draws.
- 3. Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 6 months of visit 1.
- 4. Individual has anemia (hemoglobin <9 g/dL for females and <11 g/dL for males).
- 5. Individual has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results. Health conditions may include history or presence of clinically important gastrointestinal, cardiac, renal, hepatic, endocrine (e.g., type 1 or type 2 diabetes mellitus), pulmonary, biliary, pancreatic, 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. Individual had a recent (within two weeks of screening) episode of acute gastrointestinal illness such as nausea, vomiting, or diarrhea.
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- 7. Individual has a history of frequent diarrhea or constipation that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
- 8. Individual has a history of stomach or gastrointestinal surgery (e.g., gastric bypass, cholecystectomy) that in the opinion of the Investigator, could interfere with evaluation of the study outcomes.
- 9. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- 10. Individual uses medications (over-the counter or prescription) or dietary supplements known to influence gastrointestinal motility or digestion including laxatives, enemas, or suppositories; digestive enzyme supplements, proton pump inhibitors, H2 blockers, alpha-glucosidase inhibitors, antacids; prokinetic drugs; anti-diarrheal agents, anti-cholinergic drugs including anti-spasmodics; and fiber supplements. A 14-day washout phase prior to visit 2 (day 0) is allowed for participants taking any of these products.
- 11. Unstable use (initiation or change in dose) within 30 days of visit 1 of sex hormones. Multiphasic hormonal contraceptives in which the amount of sex hormone in the active pill varies by week (i.e., biphasic, triphasic, quadriphasic) are considered unstable doses of sex hormones and are exclusionary.
- 12. Use of any weight loss medication (including over-the-counter medications and/or supplements) within 30 days of visit 1.
- 13. Individual has used an alpha-blocker, beta-blocker, or high-dose diuretic within 30 days of visit 1. Unstable use (initiation or change in dose) within 30 days of visit 1 of other antihypertensive medications is also exclusionary.
- 14. Unstable use (initiation or change in dose) within 90 days of visit 1 of thyroid hormone replacement medications.
- 15. Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg).
- 16. Individual has a recent history of cancer in the prior 2 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
- 17. Individual has signs or symptoms of an active infection of clinical significance or has taken antibiotics within 5 days prior to any visit (washout is permitted for re-scheduling of the clinic visit).
- 18. Individual regularly consumes (≥2 servings per week) protein supplements (including collagen) within 2 weeks of visit 2.
- 19. Individual has extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian).
- 20. Individual is a 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.
- 21. Individual has a known allergy or sensitivity to any ingredients in the study beverages or meals.
- 22. Individual has been exposed to any non-registered drug product within 30 days of the first screening visit.
- 23. Individual has a current or recent history (past 12 months of screening) or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
- 24. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Crossover Study to Assess the Appearance of Amino Acids in Circulation Following Acute Consumption of Two Protein Beverages
The objective of this study is to compare the appearance of amino acids in circulation following consumption of two protein beverages in adults. Secondary objectives of this study are to assess changes in gastrointestinal tolerability, glycemia, markers of subjective and physiological appetite, and nausea.
- Conditions
- Gastrointestinal Tolerability, Appetite, Amino Acids
- Being tested
- Protein Powder, Control Protein Powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein PowderDietary supplement
Contains 30 g of protein
Control Protein PowderDietary supplement
Contains 30 g of protein
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Protein Beverage | Experimental | Protein powder mixed into 8 oz of water Receives: Dietary Supplement: Protein Powder |
| Active Control - Protein Beverage | Active comparator | Control protein powder mixed into 8 oz of water Receives: Dietary Supplement: Control Protein Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Amino Acid net incremental area under the curve (niAUC)
Difference between conditions in the niAUC for the total amino acid level in plasma
Measured: 5-12 hours post-beverage consumption
Secondary outcomes (27)
Total Amino Acids area under the curve (AUC)
Differences between conditions in AUC for the total amino acid level in plasma
Measured: 0-5 hours, 5-12 hours, 0-12 hours, and 8-12 hours
Total Amino Acids niAUC
Difference between conditions in the niAUC for the total amino acid level in plasma
Measured: 0-5 hours, 0-12 hours, and 8-12 hours
Maximum concentration for total amino acids
Difference between conditions in the maximum concentration for total amino acids in plasma
Measured: 0-12 hours
Baseline-adjusted maximum concentration for total amino acids
Difference between conditions in the baseline-adjusted maximum concentration for total amino acids in plasma
Measured: 0-12 hours
Time to maximum concentration for total amino acids
Differences between conditions in the time to maximum concentration for total amino acid levels in plasma
Measured: 0-12 hours
Glucagon-like peptide-1 AUC
Differences between conditions in the AUC for glucagon-like peptide-1
Measured: 0-5 hours, 5-12 hours, and 0-12 hours
Glucagon-like peptide-1 niAUC
Differences between conditions in the niAUC for glucagon-like peptide-1
Measured: 0-5 hours, 5-12 hours, and 0-12 hours
Peptide YY AUC
Differences between conditions in the AUC for peptide YY
Measured: 0-5 hours, 5-12 hours, and 0-12 hours
Peptide YY niAUC
Differences between conditions in the niAUC for peptide YY
Measured: 0-5 hours, 5-12 hours, and 0-12 hours
Ghrelin AUC
Differences between conditions in the AUC for ghrelin
Measured: 0-5 hours, 5-12 hours, and 0-12 hours
Ghrelin niAUC
Differences between conditions in the niAUC for ghrelin
Measured: 0-5 hours, 5-12 hours, and 0-12 hours
Glucose-dependent insulinotropic polypeptide AUC
Differences between conditions in the AUC for glucose-dependent insulinotropic polypeptide
Measured: 0-5 hours, 5-12 hours, and 0-12 hours
Glucose-dependent insulinotropic polypeptide niAUC
Differences between conditions in the niAUC for glucose-dependent insulinotropic polypeptide
Measured: 0-5 hours, 5-12 hours, and 0-12 hours
Markers of subjective appetite AUC
Difference between conditions in the AUC for markers of subjective appetite (hunger, fullness, desire to eat, and prospective consumption) measured by the visual analog scale
Measured: 0-5 hours, 5-12 hours, and 0-12 hours
Markers of subjective appetite niAUC
Difference between conditions in the niAUC for markers of subjective appetite (hunger, fullness, desire to eat, and prospective consumption) measured by the visual analog scale
Measured: 0-5 hours, 5-12 hours, and 0-12 hours
Essential Amino Acids AUC
Differences between conditions in AUC for the essential amino acid level in plasma
Measured: 5-12 hours and 8-12 hours
Essential Amino Acids niAUC
Difference between conditions in the niAUC for the essential amino acid level in plasma
Measured: 5-12 hours and 8-12 hours
Leucine AUC
Differences between conditions in AUC for the leucine level in plasma
Measured: 5-12 hours
Leucine niAUC
Difference between conditions in the niAUC for the leucine level in plasma
Measured: 5-12 hours
Maximum concentration for essential amino acids
Difference between conditions in the maximum concentration for essential amino acids in plasma
Measured: 0-12 hours
Maximum concentration for leucine
Difference between conditions in the maximum concentration for leucine in plasma
Measured: 0-12 hours
Total amino acids at t = 12 hours
Difference between conditions in the total amino acid level at t = 12 hours
Measured: t = 12 hours
Essential Amino Acids at t = 12 hours
Difference between conditions in the essential amino acid level at t = 12 hours
Measured: t = 12 hours
Baseline-adjusted maximum concentration for essential amino acids
Difference between conditions in the baseline-adjusted maximum concentration for essential amino acids in plasma
Measured: 0-12 hours
Baseline-adjusted maximum concentration for leucine
Difference between conditions in the baseline-adjusted maximum concentration for leucine in plasma
Measured: 0-12 hours
Time to maximum concentration for essential amino acids
Differences between conditions in the time to maximum concentration for essential amino acid levels in plasma
Measured: 0-12 hours
Time to maximum concentration for leucine
Differences between conditions in the time to maximum concentration for leucine levels in plasma
Measured: 0-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start17 Dec 2025
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal TolerabilityStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- The Hershey Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293091
- Sponsor's protocol ID
- MB-2528
- Status last verified
- Mar 2026
- First submitted
- 2 Dec 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Crossover Study to Assess the Appearance of Amino Acids in Circulation Following Acute Consumption of Two Protein Beverages
- ClinicalTrials.gov ID
- NCT07293091
- Acronym / sponsor ID
- MB-2528
- Conditions
- Gastrointestinal Tolerability, Appetite, Amino Acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- The Hershey Company
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 18 Dec 2025 (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 objective of this study is to compare the appearance of amino acids in circulation following consumption of two protein beverages in adults. Secondary objectives of this study are to assess changes in gastrointestinal tolerability, glycemia, markers of subjective and physiological appetite, and nausea.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - Protein Beverage | Experimental | Dietary Supplement: Protein PowderProtein powder mixed into 8 oz of water |
| Active Control - Protein Beverage | Active comparator | Dietary Supplement: Control Protein PowderControl protein powder mixed into 8 oz of water |
Who may qualify
- Ages
- 25 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1. Male or female, between 25 and 54 years of age.
- 2. Individual has a body mass index (BMI) of 22.5 to 32.5 kg/m2. Only 5 participants will have a BMI of 30 to 32.5 kg/m2.
- 3. Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
- 4. Individual is willing and able to undergo the scheduled study procedures.
- 5. Individual is willing to maintain usual physical activity level for the duration of the study and not to engage in vigorous physical activity for at least 24 hours prior to each clinic visit.
Key exclusion criteria (24 listed)
- 1. Individual has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
- 2. Individual has poor venous access and is not a good candidate for serial blood draws.
- 3. Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 6 months of visit 1.
- 4. Individual has anemia (hemoglobin <9 g/dL for females and <11 g/dL for males).
- 5. Individual has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results. Health conditions may include history or presence of clinically important gastrointestinal, cardiac, renal, hepatic, endocrine (e.g., type 1 or type 2 diabetes mellitus), pulmonary, biliary, pancreatic, 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.
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 |
|---|---|---|
| Protein PowderContains 30 g of protein | Dietary supplement | Experimental - Protein Beverage |
| Control Protein PowderContains 30 g of protein | Dietary supplement | Active Control - Protein Beverage |
Primary outcome
Total Amino Acid net incremental area under the curve (niAUC)
Time frame: 5-12 hours post-beverage consumption
Difference between conditions in the niAUC for the total amino acid level in plasma
27 secondary outcomes
Total Amino Acids area under the curve (AUC)
Time frame: 0-5 hours, 5-12 hours, 0-12 hours, and 8-12 hours
Total Amino Acids niAUC
Time frame: 0-5 hours, 0-12 hours, and 8-12 hours
Maximum concentration for total amino acids
Time frame: 0-12 hours
Baseline-adjusted maximum concentration for total amino acids
Time frame: 0-12 hours
Time to maximum concentration for total amino acids
Time frame: 0-12 hours
Glucagon-like peptide-1 AUC
Time frame: 0-5 hours, 5-12 hours, and 0-12 hours
Glucagon-like peptide-1 niAUC
Time frame: 0-5 hours, 5-12 hours, and 0-12 hours
Peptide YY AUC
Time frame: 0-5 hours, 5-12 hours, and 0-12 hours
Peptide YY niAUC
Time frame: 0-5 hours, 5-12 hours, and 0-12 hours
Ghrelin AUC
Time frame: 0-5 hours, 5-12 hours, and 0-12 hours
Ghrelin niAUC
Time frame: 0-5 hours, 5-12 hours, and 0-12 hours
Glucose-dependent insulinotropic polypeptide AUC
Time frame: 0-5 hours, 5-12 hours, and 0-12 hours
Glucose-dependent insulinotropic polypeptide niAUC
Time frame: 0-5 hours, 5-12 hours, and 0-12 hours
Markers of subjective appetite AUC
Time frame: 0-5 hours, 5-12 hours, and 0-12 hours
Markers of subjective appetite niAUC
Time frame: 0-5 hours, 5-12 hours, and 0-12 hours
Essential Amino Acids AUC
Time frame: 5-12 hours and 8-12 hours
Essential Amino Acids niAUC
Time frame: 5-12 hours and 8-12 hours
Leucine AUC
Time frame: 5-12 hours
Leucine niAUC
Time frame: 5-12 hours
Maximum concentration for essential amino acids
Time frame: 0-12 hours
Maximum concentration for leucine
Time frame: 0-12 hours
Total amino acids at t = 12 hours
Time frame: t = 12 hours
Essential Amino Acids at t = 12 hours
Time frame: t = 12 hours
Baseline-adjusted maximum concentration for essential amino acids
Time frame: 0-12 hours
Baseline-adjusted maximum concentration for leucine
Time frame: 0-12 hours
Time to maximum concentration for essential amino acids
Time frame: 0-12 hours
Time to maximum concentration for leucine
Time frame: 0-12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein Powder in people with Gastrointestinal Tolerability and Appetite, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
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 7 inclusion and 24 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: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Amino Acid net incremental area under the curve (niAUC) (time frame: 5-12 hours post-beverage 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 7 Apr 2026.