ClinicalTrials.gg
CompletedNCT07293091Updated Apr 7, 2026

Assessing the Appearance of Amino Acids in Circulation Following Consumption of Protein Beverages

An interventional study of Protein Powder and Control Protein Powder in Gastrointestinal Tolerability, Appetite and Amino Acids, sponsored by Midwest Center for Metabolic and Cardiovascular Research. Completed at 1 site in United States. Open to participants aged 25 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Midwest Center for Metabolic and Cardiovascular Research · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
25 Years to 54 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastrointestinal Tolerability
  • Appetite
  • Amino Acids
03

In context

Lead sponsor

Midwest Center for Metabolic and Cardiovascular Research is the lead sponsor of 28 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 54 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. Male or female, between 25 and 54 years of age.
  • 2. Individual has a (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 to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion criteria

Exclusion Criteria:

  • 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 ( \<9 g/dL for females and \<11 g/dL for males).
  • 5. Individual has a 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.
  • 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 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 ( 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 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 , comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Experimental - Protein Beverage

    Protein powder mixed into 8 oz of water

    Dietary Supplement: Protein Powder

  • Active comparator
    Active Control - Protein Beverage

    Control protein powder mixed into 8 oz of water

    Dietary Supplement: Control Protein Powder

Interventions

  • Dietary supplementProtein Powder

    Contains 30 g of protein

  • Dietary supplementControl Protein Powder

    Contains 30 g of protein

06

What researchers measure

Primary outcomes

  1. Total Amino Acid net incremental area under the curve (niAUC)

    Difference between conditions in the niAUC for the total amino acid level in plasma

    Time frame: 5-12 hours post-beverage consumption

Secondary outcomes

  1. Total Amino Acids area under the curve (AUC)

    Differences between conditions in AUC for the total amino acid level in plasma

    Time frame: 0-5 hours, 5-12 hours, 0-12 hours, and 8-12 hours

  2. Total Amino Acids niAUC

    Difference between conditions in the niAUC for the total amino acid level in plasma

    Time frame: 0-5 hours, 0-12 hours, and 8-12 hours

  3. Maximum concentration for total amino acids

    Difference between conditions in the maximum concentration for total amino acids in plasma

    Time frame: 0-12 hours

  4. Baseline-adjusted maximum concentration for total amino acids

    Difference between conditions in the baseline-adjusted maximum concentration for total amino acids in plasma

    Time frame: 0-12 hours

  5. Time to maximum concentration for total amino acids

    Differences between conditions in the time to maximum concentration for total amino acid levels in plasma

    Time frame: 0-12 hours

  6. Glucagon-like peptide-1 AUC

    Differences between conditions in the AUC for glucagon-like peptide-1

    Time frame: 0-5 hours, 5-12 hours, and 0-12 hours

  7. Glucagon-like peptide-1 niAUC

    Differences between conditions in the niAUC for glucagon-like peptide-1

    Time frame: 0-5 hours, 5-12 hours, and 0-12 hours

  8. Peptide YY AUC

    Differences between conditions in the AUC for peptide YY

    Time frame: 0-5 hours, 5-12 hours, and 0-12 hours

  9. Peptide YY niAUC

    Differences between conditions in the niAUC for peptide YY

    Time frame: 0-5 hours, 5-12 hours, and 0-12 hours

  10. Ghrelin AUC

    Differences between conditions in the AUC for ghrelin

    Time frame: 0-5 hours, 5-12 hours, and 0-12 hours

  11. Ghrelin niAUC

    Differences between conditions in the niAUC for ghrelin

    Time frame: 0-5 hours, 5-12 hours, and 0-12 hours

  12. Glucose-dependent insulinotropic polypeptide AUC

    Differences between conditions in the AUC for glucose-dependent insulinotropic polypeptide

    Time frame: 0-5 hours, 5-12 hours, and 0-12 hours

  13. Glucose-dependent insulinotropic polypeptide niAUC

    Differences between conditions in the niAUC for glucose-dependent insulinotropic polypeptide

    Time frame: 0-5 hours, 5-12 hours, and 0-12 hours

  14. 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

    Time frame: 0-5 hours, 5-12 hours, and 0-12 hours

  15. 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

    Time frame: 0-5 hours, 5-12 hours, and 0-12 hours

  16. Essential Amino Acids AUC

    Differences between conditions in AUC for the essential amino acid level in plasma

    Time frame: 5-12 hours and 8-12 hours

  17. Essential Amino Acids niAUC

    Difference between conditions in the niAUC for the essential amino acid level in plasma

    Time frame: 5-12 hours and 8-12 hours

  18. Leucine AUC

    Differences between conditions in AUC for the leucine level in plasma

    Time frame: 5-12 hours

  19. Leucine niAUC

    Difference between conditions in the niAUC for the leucine level in plasma

    Time frame: 5-12 hours

  20. Maximum concentration for essential amino acids

    Difference between conditions in the maximum concentration for essential amino acids in plasma

    Time frame: 0-12 hours

  21. Maximum concentration for leucine

    Difference between conditions in the maximum concentration for leucine in plasma

    Time frame: 0-12 hours

  22. Total amino acids at t = 12 hours

    Difference between conditions in the total amino acid level at t = 12 hours

    Time frame: t = 12 hours

  23. Essential Amino Acids at t = 12 hours

    Difference between conditions in the essential amino acid level at t = 12 hours

    Time frame: t = 12 hours

  24. Baseline-adjusted maximum concentration for essential amino acids

    Difference between conditions in the baseline-adjusted maximum concentration for essential amino acids in plasma

    Time frame: 0-12 hours

  25. Baseline-adjusted maximum concentration for leucine

    Difference between conditions in the baseline-adjusted maximum concentration for leucine in plasma

    Time frame: 0-12 hours

  26. Time to maximum concentration for essential amino acids

    Differences between conditions in the time to maximum concentration for essential amino acid levels in plasma

    Time frame: 0-12 hours

  27. Time to maximum concentration for leucine

    Differences between conditions in the time to maximum concentration for leucine levels in plasma

    Time frame: 0-12 hours

07

Study locations

1 site
  • Ocean Wellness Center
    Miami Gardens, Florida 33169, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2025 to primary completion in Mar 2026, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2025
First posted
Dec 18, 2025
StartActual
Dec 17, 2025
Primary completionActual
Mar 3, 2026
CompletionActual
Mar 3, 2026
Last update
Apr 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07293091
Lead sponsor
Midwest Center for Metabolic and Cardiovascular Research
Collaborators
The Hershey Company
Responsible party
Sponsor
First posted
Dec 18, 2025
Start date
Dec 17, 2025
Primary completion
Mar 3, 2026
Completion
Mar 3, 2026
Last update
Apr 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Proteins

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