Effects of GlutenShield, a Prebiotic, Probiotic, and Enzyme Supplement, on the Gut Microbiome of Adults With GI Symptoms
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|ClinicalTrials.gov Identifier: NCT03403387|
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : January 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Symptoms||Dietary Supplement: GlutenShield Other: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Half of the participants will be randomized to receive the supplement and the other half will receive the placebo.|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Shield Nutraceuticals GlutenShield on Short Chain Fatty Acid Production, Gut Microbiota, and Markers of Inflammation in Individuals With GI Symptoms|
|Estimated Study Start Date :||January 22, 2018|
|Estimated Primary Completion Date :||March 31, 2018|
|Estimated Study Completion Date :||March 31, 2018|
3 capsules of GlutenShield supplement/day for 28 days
Dietary Supplement: GlutenShield
combination probiotic, prebiotic, and enzyme supplement
Placebo Comparator: Placebo
3 capsules of the placebo (Avicel and bentonite powder (for color))/ day for 28 days
Avicel (cellulose) and bentonite powder
- Change in Fermentation Profile- Short Chain Fatty Acid Concentration [ Time Frame: Baseline and Day 29 ]Measuring change short chain fatty acid concentrations in fecal matter (analyzed using gas chromatography) from baseline to after 28 days.
- Change in Microbial Population and Concentration [ Time Frame: Baseline and Day 29 ]Measuring change from baseline of fecal microbial populations and concentrations (using genomic sequencing).
- Change in Inflammation [ Time Frame: Baseline and Day 29 ]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.
- Dietary Intake [ Time Frame: Baseline ]Identifying typical dietary intake over the past month using Block Food Frequency Questionnaire
- Physical Activity [ Time Frame: Baseline ]Identifying typical physical activity over the past month using Block Food Frequency Questionnaire
- Change in Oxidative Stress [ Time Frame: Baseline and Day 29 ]Measuring changes in serum markers of oxidative stress (8-isoprostaglandin F2a)
- Changes in Psychosocial Measures of Self [ Time Frame: Baseline and Day 29 ]Measuring changes in psychosocial measures of self (Profile of Mood States 2nd Edition survey)
- Changes in Adipokine Response [ Time Frame: Baseline and Day 29 ]Measuring changes in adipokine response (Bio-Plex Pro Human Diabetes Adipsin and Adiponectin assays)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403387
|Contact: Kaitlyn M Webb, BSemail@example.com|
|Contact: Jonathan Peterson, PhDfirstname.lastname@example.org|
|United States, Tennessee|
|East Tennessee State University||Recruiting|
|Johnson City, Tennessee, United States, 37614|
|Contact: Kaitlyn Webb, BS 423-946-0977 email@example.com|
|Principal Investigator:||Kaitlyn Webb, BS||East Tennessee State University|