Effects of P24 on Postprandial Aminoacidemia

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Postprandial total amino acid incremental area under the curve after the test meal with P24 versus placebo — 0 to 180 minutes after meal consumption
  Incremental area under the curve for circulating total amino acids following consumption of the standardized test meal with P24 compared with placebo.

Trial sites (1)