An interventional study of Placebo + Meal and BC-006 + Meal in Digestive Health and Gastrointestinal Health, sponsored by University of Illinois at Urbana-Champaign. Completed at 1 site in United States. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Basic science
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.
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promote dietary protein, fat, and carbohydrate break down better than control conditions with endogenous enzymes alone (unpublished data).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.
University of Illinois at Urbana-Champaign is the lead sponsor of 188 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will be directed to consume 1 placebo capsule containing maltodextrin, twice daily, for 21 days.
Dietary Supplement: Placebo + Meal
Subjects will be directed to consume 1 capsule containing BC-006, twice daily, for 21 days.
Dietary Supplement: BC-006 + Meal
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.
Total plasma essential amino acids (EAA) area under the curve (AUC)
Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan (combined), change from baseline (BC-006 vs. placebo treatment)
Time frame: Five hours postprandial
Plasma EAA time-to-peak
Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan (combined)
Time frame: Five hours postprandial
Plasma EAA C(MAX)
Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan (combined)
Time frame: Five hours postprandial
Total plasma branched chain amino acids (BCAA) AUC
Free leucine, isoleucine, valine (combined)
Time frame: Five hours postprandial
Plasma leucine AUC
Free leucine
Time frame: Five hours postprandial
Plasma total amino acids AUC
Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, glutamine, glycine, alanine, serine, glutamic acid, aspartic acid, asparagine, tyrosine, cysteine, proline (combined)
Time frame: Five hours postprandial
Plasma fatty acid AUC
Free palmitic acid (C16:0), myristic acid (C14:0), stearic acid (C18:0), and oleic acid (C18:1n9)
Time frame: Five hours postprandial
Plasma glucose C(MAX)
Glucose (maximum)
Time frame: Five hours postprandial
Plasma glucose AUC
Glucose
Time frame: Five hours postprandial
Serum iron
Iron
Time frame: Three hours postprandial
Plasma insulin AUC
Insulin
Time frame: Five hours postprandial
Appetite
12-item Appetite Questionnaire (1 (Not at all) to 100 (Extremely))
Time frame: Five hours postprandial
Abdominal distension/bloating
Daily, 7-item Bowel Function and Gastrointestinal Tolerance Factors Questionnaire (1 (Absent) to 4 (Severe))
Time frame: Three weeks
Flatulence/gas
Daily, 7-item Bowel Function and Gastrointestinal Tolerance Factors Questionnaire (1 (Absent) to 4 (Severe))
Time frame: Three weeks
Individual GI symptoms other than abdominal distension/bloating and flatulence/gas
Burping, cramping/pain, nausea, reflux (heartburn), rumblings (Daily, 7-item Bowel Function and Gastrointestinal Tolerance Factors Questionnaire (1 (Absent) to 4 (Severe)))
Time frame: Three weeks
Composite score of GI symptoms (daily)
Burping, cramping/pain, distension/bloating, flatulence/gas, nausea, reflux (heartburn), rumblings (Daily, 7-item Bowel Function and Gastrointestinal Tolerance Factors Questionnaire (1 (Absent) to 4 (Severe)))
Time frame: Three weeks
Bowel function (frequency)
Stool frequency (Daily, 7-item Bowel Function and Gastrointestinal Tolerance Factors Questionnaire)
Time frame: Three weeks
Bowel function (consistency)
Stool consistency (Bristol stool chart) (Daily, 7-item Bowel Function and Gastrointestinal Tolerance Factors Questionnaire (1 (Separate hard lumps, like nuts) to 7 (Watery, no solid pieces, entirely liquid)))
Time frame: Three weeks
Bowel function (passage)
Ease of stool passage (Daily, 7-item Bowel Function and Gastrointestinal Tolerance Factors Questionnaire (1 (Very easy) to 5 (Very difficult)))
Time frame: Three weeks
Bloating
Weekly, 6-item Gastrointestinal Tolerance Questionnaire (0 (No more than usual) to 2 (Much more than usual))
Time frame: Three weeks
Gas/flatulence
Weekly, 6-item Gastrointestinal Tolerance Questionnaire (0 (No more than usual) to 2 (Much more than usual))
Time frame: Three weeks
Individual GI symptoms other than bloating and gas/flatulence
Weekly, 6-item Gastrointestinal Tolerance Questionnaire (0 (No more than usual) to 2 (Much more than usual))
Time frame: Three weeks
Composite score of GI symptoms (weekly)
Nausea, bloating, gastrointestinal rumblings, gas/flatulence, abdominal pain, diarrhea (Weekly, 6-item Gastrointestinal Tolerance Questionnaire (0 (No more than usual) to 2 (Much more than usual)))
Time frame: Three weeks
Composite sleep score
Hours, ease of falling asleep, amount of times woken before waking up for day, level of refreshment (Single-Item Sleep Scale (0 (Terrible) to 10 (Excellent)))
Time frame: Three weeks
Safety - Incidence of adverse events
Number of participants with self-reported adverse events
Time frame: Seven weeks
Safety - Incidence of any abnormal vital signs
Blood pressure, heart rate
Time frame: Seven weeks
Plan to share: No
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University of Illinois at Urbana-Champaign