Effects of P24 on Postprandial Aminoacidemia

Conditions

• Postprandial Amino Acid Concentrations in Healthy Adults

Eligibility Criteria

Sex

ALL

Age

45 Years - 75 Years

Healthy Volunteers

Accepted

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.

Study Details

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.

Key Dates

Start date

May 1, 2026

Status verified

May 2026

Primary completion

Dec 15, 2026

Completion

Dec 15, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

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.

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

• Roberta R Holt, PhD
  530-400-5952
  [email protected]

Locations (1)

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