Effects of Microbial Protease Supplementation on Postprandial Plasma Amino Acid Concentrations and Appetite

Appetitive Behavior Clinical Trial

Official title: Effects of Oral Microbial Protease Supplementation on Postprandial Plasma Amino Acid Concentrations and Appetite in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial

Status Completed

Clinical Trial Summary

The primary purpose of this study is to assess the effect of co-ingestion of microbial proteases and whey protein concentrate (WPC) on postprandial plasma amino acid concentrations in healthy adult participants compared to WPC with placebo. The secondary purpose is to assess the effect of co-ingestion of microbial proteases and WPC on postprandial glycemic response, subjective appetite sensations, gut-derived appetite regulating hormones, ad libitum meal intake, and gastrointestinal tolerability in healthy adult participants compared to WPC with placebo.

Clinical Trial Description

A within-subject crossover design will be used for this randomized, double-blind, placebo-controlled study in health adults to assess the efficacy of a microbial protease mixture (from Aspergillus species) on enhancing postprandial aminoacidemia after consumption of a whey protein shake. There are two treatment groups in this crossover trial, including one microbial protease group and one placebo group. A total of 24 participants will be enrolled and undergo both treatment phases with a minimum 7-day washout.

The study will last no less than 8 days and up to 72 days for each participant, including screening, washout, and end of study (EOS) visit. The study will include a screening visit (Visit 1) followed by a screening period lasting up to 30 days, the phase 1 aminoacidemia trial on Day 1 (Visit 2), minimum 7-day washout with a window of +35 days, followed by the phase 2 aminoacidemia trial (EOS Visit 3, Day 8 +35 days).

During the aminoacidemia trials, participants will arrive to the clinic in a fasted state, and 31.9 grams whey protein concentrate (WPC) in 300 mL water with microbial proteases or placebo will be administered. Blood will be collected at baseline and 11 postprandial timepoints across 4 hours for plasma amino acid, glucose, and insulin quantitation. Blood will also be utilized for quantitation of the anorexigenic, satiety-related peptide hormones glucagon-like peptide 1 (GLP-1) and peptide YY (PYY), and the orexigenic peptide hormone ghrelin.

Additionally, changes in appetite sensations will be assessed by visual analog score (VAS) responses to 5 questions at baseline, directly after consumption of study products, and postprandially every half hour. Palatability of the study products will be assessed by 5-item Palatability Questionnaire. Gastrointestinal tolerability will be assessed by 8-item modified Gastrointestinal Tolerance Questionnaire (mGITQ) at the end of the 4-hour aminoacidemia trial.

To further investigate appetite and satiety, an test meal will be provided at 4 hours for the determination of energy intake, followed by a final appetite VAS questionnaire immediately after the test meal. The maximum time to finish the test meal is 30 minutes.

To account for the potential influence of menstrual cycle timing on the outcomes of interest, female subjects will be instructed to contact the clinic on day 1 of their menses so that Visit 2 (Day 1) can be scheduled at the end of menses, but still during the follicular phase of their menstrual cycle. The follicular phase is defined as days 1-14, where day 1 is the first day of menses. Therefore, Visit 2 (Day 1) and Visit 3 for female participants will occur approximately 3-5 days after start of menses, but on or before day 14 of the follicular phase (+4 day window), unless Visit 3 can be scheduled within the same follicular phase as Visit 2, with an at least 7-day washout.

The study will include a total of three in-person visit days: screening (Visit 1), phase 1 (Visit 2), and phase 2/EOS (Visit 3). Study endpoints include postprandial plasma amino acid concentrations, postprandial plasma glucose and insulin concentrations, and postprandial plasma GLP-1, PYY, and ghrelin concentrations. Endpoints also include appetite VAS scores, ad libitum meal consumption, mGITQ scores, vital signs, anthropometric measures, and reports of adverse events, which will be assessed at all clinic visits. ;

Related Conditions & MeSH terms

• Appetitive Behavior
• Digestive Health
• Gastrointestinal Health

• NCT number: NCT05957185
• Study type: Interventional
• Source: BIO-CAT, Inc.
• Status: Completed
• Phase: N/A
• Start date: August 7, 2023
• Completion date: January 18, 2024