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

NCT07293091 | Recruiting

• 1 other identifier: MB-2528
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Tolerability; Appetite; Amino Acids

Outcome Measures

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

  5-12 hours post-beverage consumption

Secondary Outcomes (15)

• Total Amino Acids area under the curve (AUC)

  0-5 hours, 5-12 hours, and 0-12 hours

• Total Amino Acids niAUC

  0-5 hours and 0-12 hours

• Maximum concentration for total amino acids

  0-12 hours

• Baseline-adjusted maximum concentration for total amino acids

  0-12 hours

• Time to maximum concentration for total amino acids

  0-12 hours

Study Arms (2)

Experimental - Protein Beverage

EXPERIMENTAL

Protein powder mixed into 8 oz of water

Dietary Supplement: Protein Powder

Active Control - Protein Beverage

ACTIVE COMPARATOR

Control protein powder mixed into 8 oz of water

Dietary Supplement: Control Protein Powder

Interventions

Protein Powder DIETARY_SUPPLEMENT

Contains 30 g of protein

Experimental - Protein Beverage

Control Protein Powder DIETARY_SUPPLEMENT

Contains 30 g of protein

Active Control - Protein Beverage

Eligibility Criteria

• Age: 25 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Male or female, between 25 and 54 years of age.
• \. 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.
• \. Individual is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
• \. Individual is willing and able to undergo the scheduled study procedures.
• \. 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.
• \. Individual is willing to abstain from alcohol consumption for at least 24 hours prior to each clinic visit.
• \. 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.

You may not qualify if:

• \. Individual has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
• \. Individual has poor venous access and is not a good candidate for serial blood draws.
• \. Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 6 months of visit 1.
• \. Individual has anemia (hemoglobin \<9 g/dL for females and \<11 g/dL for males).
• \. 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.
• \. Individual had a recent (within two weeks of screening) episode of acute gastrointestinal illness such as nausea, vomiting, or diarrhea.
• \. 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.
• \. 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.
• \. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
• \. 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.
• \. Use of any weight loss medication (including over-the-counter medications and/or supplements) within 30 days of visit 1.
• \. Unstable use (initiation or change in dose) within 90 days of visit 1 of thyroid hormone replacement medications.
• \. Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg).
• \. Individual has a recent history of cancer in the prior 2 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
• \. 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).

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• The Hershey Company: collaborator

Study Sites (1)

Ocean Wellness Center

Miami Gardens, Florida, 33169, United States

RECRUITING

Central Study Contacts

Sara Campbell, MPH

CONTACT

630-469-6600; scampbell@mbclinicalresearch.com

Liana Guarneiri, PhD

CONTACT

630-469-6600; lguarneiri@mbclinicalresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 18, 2025
• Study Start: December 17, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)