Microbial Enzyme Impact on Postprandial Nutrient Levels and Gastrointestinal Symptoms in Healthy Adults

NCT05211440 | Completed

• 1 other identifier: 22237
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Digestive Health; Gastrointestinal Health

Keywords

Enzyme; Digestion; Protease; Amylase; Lipase

Outcome Measures

Primary Outcomes (3)

• 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)

  Five hours postprandial

• Plasma EAA time-to-peak

  Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan (combined)

  Five hours postprandial

• Plasma EAA C(MAX)

  Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan (combined)

  Five hours postprandial

Secondary Outcomes (23)

• Total plasma branched chain amino acids (BCAA) AUC

  Five hours postprandial

• Plasma leucine AUC

  Five hours postprandial

• Plasma total amino acids AUC

  Five hours postprandial

• Plasma fatty acid AUC

  Five hours postprandial

• Plasma glucose C(MAX)

  Five hours postprandial

Study Arms (2)

Placebo (Maltodextrin)

PLACEBO COMPARATOR

Subjects will be directed to consume 1 placebo capsule containing maltodextrin, twice daily, for 21 days.

Dietary Supplement: Placebo + Meal

BC-006

EXPERIMENTAL

Subjects will be directed to consume 1 capsule containing BC-006, twice daily, for 21 days.

Dietary Supplement: BC-006 + Meal

Interventions

Placebo + Meal DIETARY_SUPPLEMENT

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.

Placebo (Maltodextrin)

BC-006 + Meal DIETARY_SUPPLEMENT

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.

BC-006

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 follow dietary guidelines throughout the study.
• Subject is able to follow the protocol.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• BIO-CAT, Inc.: collaborator

Study Sites (1)

Freer Hall

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Interventions

Meals

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Nicholas A Burd, PhD

  University of Illinois Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Supplement and placebo supplements will be provided to the clinic in blindly coded containers. The code was generated by parties not responsible for data collection, analysis, or interpretation.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: January 27, 2022
• Study Start: January 18, 2022
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)