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

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.

Study Overview

• Status: Completed
• Conditions: Amino Acids; Appetite; Gastrointestinal Tolerability
• Intervention / Treatment: Dietary supplement: Protein Powder; Dietary supplement: Control Protein Powder

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami Gardens, Florida, United States, 33169
      • Ocean Wellness Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

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 (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.
• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental - Protein Beverage; Protein powder mixed into 8 oz of water	Dietary supplement: Protein Powder; Contains 30 g of protein
Active Comparator: Active Control - Protein Beverage; Control protein powder mixed into 8 oz of water	Dietary supplement: Control Protein Powder; Contains 30 g of protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Amino Acid net incremental area under the curve (niAUC)	Difference between conditions in the niAUC for the total amino acid level in plasma	5-12 hours post-beverage consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration for total amino acids	Difference between conditions in the maximum concentration for total amino acids in plasma	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	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	0-12 hours
Glucagon-like peptide-1 AUC	Differences between conditions in the AUC for glucagon-like peptide-1	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	0-5 hours, 5-12 hours, and 0-12 hours
Peptide YY AUC	Differences between conditions in the AUC for peptide YY	0-5 hours, 5-12 hours, and 0-12 hours
Peptide YY niAUC	Differences between conditions in the niAUC for peptide YY	0-5 hours, 5-12 hours, and 0-12 hours
Ghrelin AUC	Differences between conditions in the AUC for ghrelin	0-5 hours, 5-12 hours, and 0-12 hours
Ghrelin niAUC	Differences between conditions in the niAUC for ghrelin	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	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	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	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	0-5 hours, 5-12 hours, and 0-12 hours
Total Amino Acids area under the curve (AUC)	Differences between conditions in AUC for the total amino acid level in plasma	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	0-5 hours, 0-12 hours, and 8-12 hours
Essential Amino Acids AUC	Differences between conditions in AUC for the essential amino acid level in plasma	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	5-12 hours and 8-12 hours
Leucine AUC	Differences between conditions in AUC for the leucine level in plasma	5-12 hours
Leucine niAUC	Difference between conditions in the niAUC for the leucine level in plasma	5-12 hours
Maximum concentration for essential amino acids	Difference between conditions in the maximum concentration for essential amino acids in plasma	0-12 hours
Maximum concentration for leucine	Difference between conditions in the maximum concentration for leucine in plasma	0-12 hours
Total amino acids at t = 12 hours	Difference between conditions in the total amino acid level at t = 12 hours	t = 12 hours
Essential Amino Acids at t = 12 hours	Difference between conditions in the essential amino acid level at t = 12 hours	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	0-12 hours
Baseline-adjusted maximum concentration for leucine	Difference between conditions in the baseline-adjusted maximum concentration for leucine in plasma	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	0-12 hours
Time to maximum concentration for leucine	Differences between conditions in the time to maximum concentration for leucine levels in plasma	0-12 hours

Collaborators and Investigators

• Sponsor: Midwest Center for Metabolic and Cardiovascular Research
• Collaborators: The Hershey Company

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Actual): March 3, 2026
• Study Completion (Actual): March 3, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MB-2528

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