Status:
COMPLETED
Microbial Enzyme Impact on Postprandial Nutrient Levels and Gastrointestinal Symptoms in Healthy Adults
Lead Sponsor:
University of Illinois at Urbana-Champaign
Collaborating Sponsors:
BIO-CAT, Inc.
Conditions:
Digestive Health
Gastrointestinal Health
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief 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 ...
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....
Eligibility Criteria
Inclusion
- Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
- Subject is male or female and is ≥ 40 and ≤ 75 years of age.
- Subject has Body Mass Index (BMI) ≥ 18 but \< 30 kg/m2.
- Subject has fasting blood sugar level of 100 mg/dL or lower.
- Subject is willing to refrain from exclusionary medications, supplements, and products throughout the study.
- Subject is willing to follow dietary guidelines throughout the study.
- Subject is able to follow the protocol.
Exclusion
- Subject states they regularly consume supplemental enzymes and are unwilling to stop at least one week prior to screening and throughout the study. Supplemental enzymes may include standalone enzyme supplements, probiotic supplements with enzymes, and any medications containing enzymes.
- Subject states they regularly consume probiotic supplements and are unwilling to stop at least one week prior to screening and throughout the study. Supplemental probiotics may include standalone probiotic supplements, vitamins with probiotics, and any foods supplemented with probiotics.
- Subject states they have an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea, gall bladder removal).
- Subject states they have dairy or lactose intolerance.
- Subject states they have diabetes.
- Subject states they have undergone bariatric surgery.
- Subject states they have an active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix.
- Subject states they have liver failure (decompensated chronic liver disease).
- Subject has a stated history of a significant cardiovascular event (e.g., myocardial infarction, heart failure, or stroke) ≤ 3 months prior to screening visit.
- Subject states they are currently diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study dietary supplement consumption or compliance with study protocol procedures in the opinion of the principal investigator or study physician.
- Subject reports having undergone major surgery, less than 6 weeks prior to enrollment in the study, or subject has planned inpatient surgery requiring hospitalization during the study.
- Subject states they are currently being prescribed (by primary care physician or other health professional) medication or using an over-the-counter product that in the opinion of the study physician will have an effect on food digestion or nutrient absorption during the study. Examples include prescription orlistat (Xenical) and over-the-counter orlistat (Alli).
- Subject reports having received a COVID vaccine within 1 week of randomization or expected to receive a COVID vaccine during the study period.
- Subject reports having previously had a positive SARS-CoV-2 test and experience symptoms for \>2 months (i.e., "long-haulers").
- Subject reports alcohol intake as average of 3 or more servings per day (a serving defined as 4 oz wine, 12 oz beer, 1 oz spirits).
- Subject states they are pregnant or lactating or planning to become pregnant during the study.
- Subject states they have an allergy or intolerance to any ingredient in the study product or test meal.
- Subject is deemed unsuitable for study based upon study physician assessment.
- Subject is taking part in another clinical trial.
Key Trial Info
Start Date :
January 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05211440
Start Date
January 18 2022
End Date
August 25 2023
Last Update
September 18 2023
Active Locations (1)
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1
Freer Hall
Urbana, Illinois, United States, 61801