Microbial Enzyme Impact on Postprandial Nutrient Levels and Gastrointestinal Symptoms in Healthy Adults
Condition: Digestive Health; Gastrointestinal Health
Study type: Interventional

Summary: 
      The primary objective of this study is to investigate the acute effects of a microbial
      multi-enzyme mixture ("BC-006") on postprandial nutrient levels in healthy, middle-aged to
      older adults during a mixed meal tolerance test. Additionally, the effects of twice daily
      consumption of BC-006 and placebo for 3 weeks on abdominal bloating, flatulence, bowel
      function, and sleep quality will be measured.
    

Detailed description: 
      Digestive enzymes of the human stomach, pancreas, and small intestine, are proteins that help
      facilitate the breakdown of dietary macronutrients for adequate nutrient supply across
      tissues and organs. Protease enzymes hydrolyze dietary proteins and release the amino acid
      building blocks of human proteins. Lipase enzymes hydrolyze dietary fats and release
      monoglycerides and fatty acids which can be absorbed by enterocytes and distributed across
      tissues and organs for energy, immune support, and structural support. Some carbohydrase
      enzymes, such as a combination of amylase and glucoamylase, hydrolyze carbohydrates and
      release monosaccharides that fuel the grand majority of metabolism within cells of most
      individuals on a diet that includes carbohydrates.

      Digestive function and digestive enzyme output have been shown to decline in several clinical
      observational studies of younger and older adults, suggesting the potential value of oral,
      supplemental enzymes in older adults. Supplemental enzyme preparations manufactured by
      fermentation of non-genetically engineered, microbial source organisms, e.g., Aspergillus
      spp., have been on the market for decades to support digestive health and gastrointestinal
      tolerance. However, clinical data in older adult subjects is lacking.

      BIO-CAT's proprietary mixture of 6 microbial enzymes ("BC-006") has previously been shown in
      in vitro gastrointestinal simulations to promote dietary protein, fat, and carbohydrate break
      down better than control conditions with endogenous enzymes alone (unpublished data). BC-006
      comprises a mixture of proteases, lipase, amylase, and glucoamylase. The primary objective of
      this clinical study is to investigate the effect of BC-006 supplementation on postprandial
      nutrient levels in healthy, middle-aged to older adults during a mixed meal tolerance test.
      Abdominal bloating, flatulence, bowel function, and sleep quality will also be measured
      across 3 weeks of twice daily supplementation.

      This study will be a randomized, placebo-controlled, crossover design trial consisting of a
      preliminary virtual screen and 4 study visits (Visits 1-4). During the preliminary virtual
      screening, subjects will provide voluntary informed consent, subjects will undergo medical
      history, prior and current medication/supplement use assessments, as well as inclusion and
      exclusion criteria assessments. At Visit 1, subjects will arrive at the clinic in a fasting
      state. Height, body weight, and vital signs will be measured and BMI will be calculated from
      a dual-energy X-ray absorptiometry (DEXA) scan. A blood sample will be collected for rapid
      fasting blood glucose analysis. Upon assessment of all eligibility criteria, subjects may be
      enrolled and randomized to BC-006 or placebo arms. Subjects will be dispensed their assigned
      study product and will be instructed to consume it twice daily (2 capsules/day) with their
      largest meals for 21 days. Subjects will be dispensed a paper Bowel Function and
      Gastrointestinal Tolerance Factors Questionnaire (BF-GITFQ) to be completed daily. The
      BF-GITFQ contains a series of questions regarding bowel function and the presence and
      severity of GI symptoms occurring during the past 24 hours. Subjects will also be dispensed a
      paper Gastrointestinal Tolerance Questionnaire (GITQ) which contains a series of questions
      regarding GI symptoms occurring during the past 7 days. To assess sleep quality, subjects
      will be dispensed a paper Single-Item Sleep Quality Scale (SI-SQS) to be completed weekly,
      leading up to Visit 2.

      At Visit 2, subjects will arrive at the clinic fasted and undergo clinic visit procedures
      (concomitant medication/supplement use, assess inclusion/exclusion criteria, body weight and
      vital signs measurements), and adverse event (AE) assessment. Subjects will undergo a mixed
      meal tolerance test (MMTT). The MMTT includes antecubital vein placement, baseline blood
      sample collection, provision of a standardized test meal with BC-006 or placebo, and blood
      sampling thereafter for 5 hours. Blood samples will be collected for analysis of free amino
      acids, free fatty acids, glucose, iron, and insulin. An electronic Appetite Questionnaire
      will also be conducted hourly during the MMTT.

      Following an at least 7 day washout, subjects will return to the clinic at Visit 3 and
      undergo clinic visit procedures and AE assessment. Subjects will be dispensed the second
      study product, with instructions and questionnaires similar to the first 21 day phase of the
      trial. At Visit 4, subjects will arrive at the clinic fasted and undergo clinic visit
      procedures and AE assessment. Subjects will undergo a second MMTT with the second study
      product, otherwise identical to the MMTT at Visit 2.
    

Intervention name(s): Placebo + Meal; BC-006 + Meal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will be directed to consume 1 placebo capsule containing maltodextrin, twice daily, for 21 days. Subjects will be directed to consume the capsules with their two largest meals, in between the third and second bites of food. During the MMTT, a placebo capsule will be consumed with a standardized test meal containing chicken, peas, potatoes, and butter.; Subjects will be directed to consume 1 capsule containing BC-006, twice daily, for 21 days. Subjects will be directed to consume the capsules with their two largest meals, in between the third and second bites of food. During the MMTT, a BC-006 capsule will be consumed with a standardized test meal containing chicken, peas, potatoes, and butter.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Enzyme; Digestion; Protease; Amylase; Lipase