Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds

Study Overview
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Brief Summary
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The purpose of the study is to determine the effects of both an anthocyanin-rich polyphenol blend and an anthocyanin-rich polyphenol blend combined with a prebiotic blend on fecal microbiota metabolism (assessed by gas chromatograph - mass spectrometry (GC-MS) headspace analysis) and fecal microbiota composition (assessed by next generation sequencing).

Official Title
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Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds - a Randomized, Placebo-controlled, Double-blind, Cross-over Study

Conditions
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Healthy

Intervention / Treatment
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* Other: Placebo
* Dietary Supplement: Flavonoids
* Dietary Supplement: Flavonoids+Prebiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female of any race or ethnicity between 18 to 70 years of age, inclusive; Body mass index (BMI) between 20 - 32 inclusive; Non-smoking status; Willing to consume assigned dietary supplements for a total of 6 weeks; Have access to email and a digital camera or camera phone. Exclusion Criteria: Age <18 or >70 years; BMI <20 or >32; Uncontrolled hypertension defined as diastolic blood pressure ≥95 mm Hg or systolic blood pressure ≥160 mm Hg; Self-reported presence of atherosclerotic disease and/or cardiopulmonary disease; Renal, hepatic, endocrine, gastrointestinal or other systemic disease; For women, pregnancy, breast feeding or postpartum less than 6 months; Current participation in another research study; Allergy to the components in the dietary supplement (inulin, fructooligosaccharide, blueberries, black currant, rice); History of drug or alcohol abuse; Use of antibiotics within the last 6 months; Use of prebiotics or flavonoid-containing dietary supplements within the last 30 days; Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence; Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids; Participating in or planning to begin a weight loss diet during the study period; Lifestyle or schedule incompatible with the study protocol; Other medical, psychiatric, or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol; Use of tobacco products.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo,Flavonoids,Flavonoids+Prebiotics<br>Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. | Other: Placebo<br>* A combination of maltodextrins and red and blue food colors.<br>Dietary Supplement: Flavonoids<br>* A combination of blueberry extract, black current extract, and black rice extract.<br>Dietary Supplement: Flavonoids+Prebiotics<br>* A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.<br>|
| Experimental: Placebo,Flavonoids+Prebiotics,Flavonoids<br>Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. | Other: Placebo<br>* A combination of maltodextrins and red and blue food colors.<br>Dietary Supplement: Flavonoids<br>* A combination of blueberry extract, black current extract, and black rice extract.<br>Dietary Supplement: Flavonoids+Prebiotics<br>* A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.<br>|
| Experimental: Flavonoids,Placebo,Flavonoids+Prebiotics<br>Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. | Other: Placebo<br>* A combination of maltodextrins and red and blue food colors.<br>Dietary Supplement: Flavonoids<br>* A combination of blueberry extract, black current extract, and black rice extract.<br>Dietary Supplement: Flavonoids+Prebiotics<br>* A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.<br>|
| Experimental: Flavonoids,Flavonoids+Prebiotics,Placebo<br>Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. | Other: Placebo<br>* A combination of maltodextrins and red and blue food colors.<br>Dietary Supplement: Flavonoids<br>* A combination of blueberry extract, black current extract, and black rice extract.<br>Dietary Supplement: Flavonoids+Prebiotics<br>* A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.<br>|
| Experimental: Flavonoids+Prebiotics,Placebo,Flavonoids<br>Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. | Other: Placebo<br>* A combination of maltodextrins and red and blue food colors.<br>Dietary Supplement: Flavonoids<br>* A combination of blueberry extract, black current extract, and black rice extract.<br>Dietary Supplement: Flavonoids+Prebiotics<br>* A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.<br>|
| Experimental: Flavonoids+Prebiotics,Flavonoids,Placebo<br>Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. | Other: Placebo<br>* A combination of maltodextrins and red and blue food colors.<br>Dietary Supplement: Flavonoids<br>* A combination of blueberry extract, black current extract, and black rice extract.<br>Dietary Supplement: Flavonoids+Prebiotics<br>* A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fecal volatile methyl sulfides at day 21, day 63, day 105 | assessed by gas chromatograph - mass spectrometry (GC-MS) headspace analysis | baseline, day 21, day 63, day 105 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in all fecal VOCs at day 21, day 63, day 105 |  | baseline, day 21, day 63, day 105 | 
| Change from baseline fecal short chain fatty acids at day 21, day 63, day 105 |  | baseline, day 21, day 63, day 105 | 
| Change from baseline fecal microbiota composition at day 21, day 63, day 105 |  | baseline, day 21, day 63, day 105 |