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| Name | Class |
|---|---|
| Shield Nutraceuticals | UNKNOWN |
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This study evaluates the effects of combination probiotic, prebiotic, and enzyme supplementation on the colonic microbiome of individuals with GI symptoms (e.g. diarrhea, constipation, increased gas). Half of the participants will receive the placebo while the other half will receive the supplement for 28 days.
The purpose of this research is to identify if there is a relationship between GlutenShield, a combination prebiotic, probiotic, and enzyme supplement, and the gut environment.
The study will be a split, 28-day randomized, partially blinded design. Subjects will be randomly assigned to one of two groups. One group will complete a 28-day treatment period with GlutenShield taken 3x/day with meals. The other group will complete a 28-day placebo period with the placebo taken 3x/day with meals. The placebo will contain Avicel (cellulose) and bentonite powder (to have a similar color as GlutenShield). Participants will be blinded to which group/ treatment they are being given. Serum and fecal samples will be collected at baseline and on day 29. Participants will also complete a gastrointestinal symptoms questionnaire, a food frequency questionnaire and a psychosocial measures of self questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GlutenShield | Experimental | 3 capsules of GlutenShield supplement/day for 28 days |
|
| Placebo | Placebo Comparator | 3 capsules of the placebo (Avicel and bentonite powder (for color))/ day for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlutenShield | Dietary Supplement | combination probiotic, prebiotic, and enzyme supplement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fermentation Profile- Short Chain Fatty Acid Concentration | Measuring change short chain fatty acid concentrations in fecal matter (analyzed using gas chromatography) from baseline to after 28 days. | Baseline and Day 29 |
| Change in Microbial Population and Concentration | Measuring change from baseline of fecal microbial populations and concentrations (using genomic sequencing). | Baseline and Day 29 |
| Change in Inflammation | Measuring change in serum markers of inflammation (IgA and IgG, GM-CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α) over 28 days. Values will be used to determine a change in overall inflammatory status. | Baseline and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Intake | Identifying typical dietary intake over the past month using Block Food Frequency Questionnaire | Baseline |
| Physical Activity | Identifying typical physical activity over the past month using Block Food Frequency Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaitlyn M Webb, BS | Contact | 423-946-0977 | webbkm1@etsu.edu | |
| Jonathan Peterson, PhD | Contact | 423-439-4726 | petersonjm1@etsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kaitlyn Webb, BS | East Tennessee State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Tennessee State University | Recruiting | Johnson City | Tennessee | 37614 | United States |
There is no plan to share individual participant data. Data will be de-identified.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 14, 2019 | |
| Reset | Jul 19, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 14, 2019 | Jul 19, 2019 |
Half of the participants will be randomized to receive the supplement and the other half will receive the placebo.
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| Placebo |
| Other |
Avicel (cellulose) and bentonite powder |
|
| Baseline |
| Change in Oxidative Stress | Measuring changes in serum markers of oxidative stress (8-isoprostaglandin F2a) | Baseline and Day 29 |
| Changes in Psychosocial Measures of Self | Measuring changes in psychosocial measures of self (Profile of Mood States 2nd Edition survey) | Baseline and Day 29 |
| Changes in Adipokine Response | Measuring changes in adipokine response (Bio-Plex Pro Human Diabetes Adipsin and Adiponectin assays) | Baseline and Day 29 |