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

Midwest Center for Metabolic and Cardiovascular Research

Status: Enrolling

Conditions: Amino Acids; Gastrointestinal Tolerability; Appetite

Treatments: Dietary Supplement: Protein Powder; Dietary Supplement: Control Protein Powder

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07293091

MB-2528

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 25 to 54 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

30 participants in 2 patient groups

Experimental - Protein Beverage

Experimental group

Description:

Protein powder mixed into 8 oz of water

Treatment:

Dietary Supplement: Protein Powder

Active Control - Protein Beverage

Active Comparator group

Description:

Control protein powder mixed into 8 oz of water

Treatment:

Dietary Supplement: Control Protein Powder