Effects of P24 on post-meal amino acids in healthy adults
Official title: Effects of an Acid-Active Protease (P24) on Postprandial Aminoacidemia Following a Standardized Mixed-Protein Burger Meal in Healthy Adults
Run by Amplifye · NCT07479173 · Data updated 2026-11-12
This study tests whether the acid-active protease P24 changes amino acid levels after a mixed-protein meal in healthy adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 75 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Amplifye Industry-sponsored |
| Locations | 1 site (Davis, California) |
| Status | Recruiting |
| Started | September 5, 2026 |
| Main results expected | March 31, 2027 |
| Study ends | December 15, 2027 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07479173 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 45–75 with BMI 18.5–35 kg/m2 who can consume the test meal and comply with study procedures.
✕Probably not a fit
Individuals with GI disorders, diabetes, certain medications, high blood pressure, pregnancy, smoking, or severe dietary restrictions may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled crossover trial in healthy adults to see if the protease enzyme supplement P24 alters postprandial amino acid availability after a standardized mixed-protein meal. Participants receive P24 in one morning visit and placebo in a separate visit about a week apart, serving as their own controls. Primary outcomes compare total postprandial amino acid responses between P24 and placebo; secondary outcomes include essential and branched-chain amino acids, glucose, GLP-1, GIP, insulin, plasma peptide profiles, and subjective appetite and GI symptoms. Pre-test standardization limits confounding factors such as exercise, diet, and caffeine or alcohol use.
Why it matters
Potential benefit: If successful, P24 could help optimize amino acid availability after meals in healthy adults.
How similar studies have gone: Previous studies in enzyme supplementation have shown modest effects on digestion and amino acid responses, but this specific P24 postprandial profile in a crossover design is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy adults aged 45-75 years * BMI 18.5-35 kg/m2 * Able to provide informed consent and comply with study procedure * Willing to consume the standardized mixed-protein test meal Exclusion Criteria: * BMI outside of 18.5-35 kg/m2 * Gastrointestinal disorders or malabsorption syndromes that could affect digestion/absorption (e.g., inflammatory bowel disease, celiac disease) * Diagnosed diabetes * Current use of medications or supplements that materially affect glucose metabolism or digestion (e.g., GLP-1 receptor agonists, chronic digestive enzyme supplementation) * Resting blood pressure ≥ 140/90 mmHg * Self-reported cancer within past 5 years * Known allergy or intolerance to meal components or capsule ingredients * Self-reported anemia or other conditions that increase risk from blood draws * Pregnancy or breastfeeding * Current smoking or nicotine use, heavy alcohol use (defined as \> 5 drinks/day or \> 15 drinks/week), or other factors that in the investigator's judgment make participation unsafe
Where it's running
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Ragle Human Nutrition Center
Davis, California, United States Recruiting
Study contacts
- Principal investigator: Roberta H Holt, PhD — University of California, Davis
- Study coordinator: Roberta Holt, PhD
- Email: rrholt@ucdavis.edu
- Phone: 530-400-5952
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.