Digestive, Gastrointestinal Health
Conditions
Keywords
enzyme, enzyme cocktail, healthy adults, nutraceutical
Brief summary
The goal of this study is to determine the safety and efficacy of two enzyme cocktails in healthy adults with mild to moderate gastrointestinal discomfort. The main question aims to answer whether a 4-week administration of an enzyme cocktail can improve how the participant feels about their gut health. This is done by completing a weekly questionnaire, and the results are compared between the 4 weeks the participants are on a placebo and the 4 weeks the participants are on the enzyme cocktail. Participants will also provide a stool sample at the start and end of each treatment. Stool samples will collected and stored in case further microbiome analysis is warranted.
Interventions
DIETARY_SUPPLEMENTEnzyme Cocktail A
Enzyme cocktail A in the form of a capsule with a daily dose of 275mg taken 3 times a day for 4 weeks.
DIETARY_SUPPLEMENTEnzyme Cocktail B
Enzyme cocktail B in the form of a capsule with a daily dose of 50mg taken 3 times a day for 4 weeks.
DIETARY_SUPPLEMENTPlacebo A
Placebo A matching investigational product A given 3 times a day for 4 weeks.
DIETARY_SUPPLEMENTPlacebo B
Placebo B matching investigational product B given 3 times a day for 4 weeks.
Sponsors
University of North Texas, Denton, TX
The Archer-Daniels-Midland Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Exclusion criteria
* Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy or significant abdominal disorder * Having taken oral antibiotics in the previous 3-months or if they start antibiotics during the study * Currently or having taken a prebiotic, probiotic, or digestive enzyme supplement in the previous 3-months * Currently consuming 1 or more servings of fermented foods or yogurt on a daily basis * Doctor diagnosed chronic disease (i.e. Diabetes, Cardiovascular, etc.) * Doctor diagnosed immunodeficiency * Current use of doctor prescribed immunosuppressive agents (corticosteroids, methotrexate, etc.) * Pregnancy, 6 months postpartum period, or current breastfeeding * Women of childbearing age planning pregnancy during the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Gastrointestinal Symptoms Rating Scale - Irritable Bowel Syndrome (GSRS-IBS) | From baseline to the end of intervention 4 weeks later. | Change in GSRS-IBS total score from baseline to end of intervention. Each question is rated on a 7 point Likert scale with higher scores representing more troublesome symptoms. Questionnaire collected weekly from baseline through study completion at the end of week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Stool Frequency at end of intervention | Through study completion, an expected average of 70 days | Change in weekly average stool frequency throughout the period between baseline and end of intervention. |
| Change in Microbiome (faecal samples) | Day 0 and Day 28; Day 42 and Day 70 | Change in stool microbiome between baseline and end of intervention for each of cross over runs (Change between day 0 and day 28, change between day 42 and 70) |
| Body Mass Index (BMI) | Day 0, Day 28, Day 42, and Day 70 | Participants whole-body weight \[kg\] and height \[m\] will be measured and BMI will be calculated as kg/m\^2 |
| Change from baseline in Stool Consistency at end of intervention | Through study completion, an expected average of 70 days | Difference in weekly self reported stool consistency, as measured by the Bristol Stool Form Scale (BSFS) on a daily basis. BSFS max score 7 - lower scores indicate constipation, higher scores indicate diarrhea. |
| Food Intake | Day 0 | Food intake is measured by the NHANES Food Frequency Questionnaire (NHANES-FFQ), which collects data to measure habitual food intake at baseline. |
| Positive and Negative Affect Schedule (PANAS-SF) | Day 0, Day 28, Day 42, and Day 70 | The PANAS-SF is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). |
| Total Fat Mass | Day 0, Day 28, Day 42, and Day 70 | Participants total fat mass (kg) will be tested using a BIA scale. |
Countries
United States
Contacts
Primary ContactDr. McFarlin
Outcome results
None listed