Effects of Microbial Protease Supplementation on Postprandial Plasma Amino Acid Concentrations and Appetite
Condition: Digestive Health; Gastrointestinal Health; Appetitive Behavior
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): OPTIZIOME® P³ HYDROLYZER® - WHEY; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): One dose of P3 - WHEY will be combined with 31.9 grams whey protein concentrate in 300 mL water and consumed within 5 minutes at the start of each of the aminoacidemia trials.; One dose of placebo maltodextrain will be combined with 31.9 grams whey protein concentrate in 300 mL water and consumed within 5 minutes at the start of each of the aminoacidemia trials.
Other intervention name(s): P3 - WHEY; P3 HYDROLYZER® - WHEY
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: protease; digestive enzyme; digestion; dietary supplement