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Effects of P24 on Postprandial Aminoacidemia

Sponsor: Amplifye • ClinicalTrials.gov ID: NCT07479173

Registry updated: 2026-09-09

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Description

The purpose of this study is to quantify the acute effects of an acid-active protease enzyme supplement (P24) on postprandial aminoacidemia following consumption of a standardized mixed-protein meal containing both plant- and animal-derived protein sources. Secondary objectives include evaluating the postprandial plasma peptidomic response, characterizing the postprandial hormonal responses (GLP-1, insulin, and GIP), and assessing the postprandial glucose response using standardized capillary blood glucose measurements. The study will also evaluate subjective responses including satiety and hunger and gastrointestinal symptoms.

Interventions

Protease enzyme supplement (Dietary supplement)
Participants receive one capsule containing P24, an acid-active protease enzyme preparation, prior to consumption of a standardized mixed-protein burger meal during one study visit. The intervention is administered in a randomized, double-blind, placebo-controlled crossover design and is compared with a matching placebo capsule containing microcrystalline cellulose. Postprandial responses are assessed over 180 minutes following meal consumption.
Placebo (Other)
Participants receive one matching placebo capsule containing microcrystalline cellulose prior to consumption of a standardized mixed-protein burger meal during one study visit. The placebo is identical in appearance to the active capsule and is administered in a randomized, double-blind, placebo-controlled crossover design. Postprandial responses are assessed over 180 minutes following meal consumption.

Eligibility 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

Conditions

Postprandial Amino Acid Concentrations in Healthy Adults

Locations

Ragle Human Nutrition Center — Davis, California, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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