Status:
COMPLETED
Effect of Microbial Protease Supplementation on Postprandial Amino Acid Levels
Lead Sponsor:
University of Illinois at Urbana-Champaign
Collaborating Sponsors:
BIO-CAT, Inc.
Conditions:
Protein Metabolism
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief Summary
Dietary protein is digested in the stomach and intestines to smaller peptides and 20 individual amino acids which, when absorbed by the gut into circulation and taken up by skeletal muscle, help stimu...
Eligibility Criteria
Inclusion
- Aged between 20 - 50 years
- Body mass index = 18.0-29.9 kg∙m-2
Exclusion
- Age outside of range (20 - 50 y)
- Pregnancy
- 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 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)
- 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)
- Diabetes (fasting glucose ≥ 126 mg/dL)
- Active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix
- Liver failure (decompensated chronic liver disease)
- History of a significant cardiovascular event (e.g., myocardial infarction, heart failure, or stroke) ≤ 3 months prior to the screening visit
- Subject reports having undergone major surgery less than 6 weeks prior to enrollment in the study, or subject has planned inpatient surgery requiring 2 or more days of hospitalization during the entire study
- 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 (e.g., prescription orlistat \[Xenical\], over the counter orlistat \[Alli\])
- Alcohol intake an average of 3 or more servings per day (a serving defined as 4 oz wine, 12 oz beer, 1 oz spirits)
- Subject is deemed unsuitable for study based upon study physician assessment
- Irregular menstrual cycles
- Participation in other ongoing research that interferes with this study (e.g., conflicting diet, activity interventions, etc.)
- Any hospitalization or surgery for a metabolic, cardiovascular, or neuromusculoskeletal complication within the past year
- Allergy or hypersensitivity to latex or adhesives (bandages, medical tape, etc.)
- Chronic or frequent dizziness/fainting, and arm or leg weakness/numbness
- Mental Illness
- Hepatorenal, cardiovascular musculoskeletal, autoimmune, or neurological disease or disorder
- Consumption of thyroid, androgenic, or other medications known to affect endocrine function
- Consumption of medications known to affect protein metabolism (e.g., prescription-strength corticosteroids, non-steroidal anti-inflammatories, or acne medication)
- Unwillingness to comply with study procedures
- Weight unstable (variation \>5% of bodyweight in last 6 months)
- Current or previous tobacco or marijuana use within the last 6 months
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04821557
Start Date
March 30 2021
End Date
September 3 2021
Last Update
July 5 2024
Active Locations (1)
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1
Freer Hall; University of Illinois at Urbana-Champaign
Urbana, Illinois, United States, 61801