An interventional study of Protease enzyme supplement and Placebo in Postprandial Amino Acid Concentrations in Healthy Adults, sponsored by Amplifye. Recruiting at 1 site in United States. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Amplifye · Not applicable, Interventional, and Other
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.
This study is a randomized, double-blind, placebo-controlled crossover trial designed to evaluate the acute effects of an acid-active protease enzyme supplement (P24) on postprandial amino acid availability after consumption of a standardized mixed-protein meal in healthy adults. Each participant will complete two morning test visits separated by an approximately 7-day washout period and will receive P24 during one visit and placebo during the other visit in randomized order. Each participant will therefore serve as his or her own control.
The primary objective is to compare postprandial circulating total amino acid responses between the P24 and placebo conditions following the test meal. Secondary objectives are to evaluate essential amino acids, branched-chain amino acids, postprandial glucose responses, postprandial hormonal responses including GLP-1, GIP, and insulin, plasma peptide profiles, and subjective responses such as hunger, satiety, and gastrointestinal symptoms.
Visits will be conducted in the morning after an overnight fast. Pre-visit standardization will include restrictions on vigorous exercise, alcohol, nicotine, and caffeine prior to each test visit, as well as instructions to maintain similar dietary intake before each study period. At the first visit, height and weight will be measured. At each visit, participants will complete brief questionnaires related to recent diet and activity, sleep, gastrointestinal symptoms, and subjective appetite.
An indwelling intravenous catheter will be placed in a forearm vein for repeated venous blood collection. Venous blood samples will be collected at baseline and at multiple postprandial timepoints over 180 minutes following meal consumption. Capillary blood glucose will also be assessed at matched timepoints using standardized finger-prick measurements. Participants will remain on site during the postprandial observation period and will be monitored for adverse events and procedure-related symptoms.
The test meal will be a standardized mixed-protein burger meal designed to include both animal-derived and plant-derived protein sources. Meal composition, preparation, and serving procedures will be standardized across visits. Participants will consume the meal with water within a defined time window. On each study day, participants will receive either one P24 capsule or one matching placebo capsule immediately prior to the meal according to the study randomization schedule. Active and placebo products will be identical in appearance to maintain blinding.
Targeted amino acid analysis will be performed using LC-MS/MS to quantify circulating amino acid concentrations across the postprandial period. The primary endpoint will be incremental area under the curve for total amino acids over 0 to 180 minutes. Secondary amino acid outcomes will include essential amino acids, branched-chain amino acids, and selected kinetic parameters including maximum observed concentration and time to maximum concentration. Hormonal outcomes will include GLP-1, GIP, and insulin measured at prespecified timepoints. Glucose outcomes will include postprandial incremental area under the curve and related peak and variability measures based on discrete capillary sampling.
Exploratory plasma peptidomic profiling will be conducted in a subset of participants using aliquots from routine plasma samples collected during study visits, without additional blood collection. Subset selection will be performed using prespecified balancing criteria and will not be based on the magnitude or direction of observed treatment effects.
Data will be analyzed using statistical methods appropriate for a crossover design, including paired or mixed-effects approaches as appropriate for each outcome. Standardized procedures for visit conduct, sample handling, laboratory processing, and data review will be used to support data quality and protocol consistency.
This is the only study on the registry with Amplifye as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Dietary Supplement: Protease enzyme supplement
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.
Other: Placebo
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.
Also known as: P24
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.
Postprandial total amino acid incremental area under the curve after the test meal with P24 versus placebo
Incremental area under the curve for circulating total amino acids following consumption of the standardized test meal with P24 compared with placebo.
Time frame: 0 to 180 minutes after meal consumption
Postprandial essential amino acid and branched-chain amino acid responses after the test meal with P24 versus placebo
Incremental area under the curve for circulating essential amino acids and branched-chain amino acids, as well as maximum observed concentration and time to maximum concentration, following consumption of the standardized test meal with P24 compared with placebo.
Time frame: 0 to180 minutes after meal consumption
Postprandial plasma hormone responses after the test meal with P24 versus placebo
Incremental area under the curve, maximum observed concentration, and time to maximum concentration for GLP-1, GIP, and insulin following consumption of the standardized test meal with P24 compared with placebo. Hormones will be measured at baseline and at 60 and 180 minutes after meal consumption.
Time frame: Baseline, 60 minutes after meal consumption, and 180 minutes after meal consumption
Postprandial plasma peptide profile after the test meal with P24 versus placebo
Differential peptide abundances in plasma following consumption of the standardized test meal with P24 compared with placebo. Plasma peptide profiling will be assessed at baseline and at 60 and 180 minutes after meal consumption.
Time frame: Baseline, 60 minutes after meal consumption, and 180 minutes after meal consumption
Postprandial capillary blood glucose responses after the test meal with P24 versus placebo
Incremental area under the curve, peak glucose, time to peak glucose, and variability metrics for capillary blood glucose following consumption of the standardized test meal with P24 compared with placebo.
Time frame: Baseline and 30, 60, 90, 120, and 180 minutes after meal consumption
Plan to share: No
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