Recruiting

P24

Sponsor:

Amplifye

Code:

NCT07479173

Conditions

Postprandial Amino Acid Concentrations in Healthy Adults

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Protease enzyme supplement

Placebo

Study Details

Brief summary:

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.

Conditions

Postprandial Amino Acid Concentrations in Healthy Adults

Study ID

NCT07479173

Start date

Sep 5, 2026

Status verified date

Sep, 2026

Completion date

Dec 15, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Protease enzyme supplement

P24 is an acid-active protease enzyme supplement administered as one capsule prior to the standardized mixed-protein burger meal. The active product contains P24 and is compared with a matching placebo capsule in a randomized, double-blind crossover design in healthy adults

placebo comparator: Placebo

Matching placebo capsule containing microcrystalline cellulose, administered prior to the standardized mixed-protein burger meal. Placebo capsules are identical in appearance to the active product and are used to maintain blinding in the randomized crossover design.

Interventions

Protease enzyme 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

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.

Primary outcome measure

  • Postprandial total amino acid incremental area under the curve after the test meal with P24 versus placebo [ Time Frame: 0 to 180 minutes after meal consumption ]

Central Contacts and Locations

Central contacts

Roberta Holt, PhD

530-400-5952rrholt@ucdavis.edu

Holt

rrholt@ucdavis.edu

Locations

Ragle Human Nutrition Center

Recruiting

Davis, California, United States, 95616

Contacts

Roberta H Holt, PhD

530-400-5952rrholt@ucdavis.edu

More Information

Sponsor

Amplifye

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amplifye on 2026-09-09.