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Effects of P24 on Postprandial Aminoacidemia

NCT07479173 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-07

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

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.

Sponsors & Collaborators

  • Amplifye

    lead INDUSTRY

Principal Investigators

  • Roberta H Holt, PhD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-12-15
Completion
2027-12-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07479173 on ClinicalTrials.gov