Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds



Status:Not yet recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 70
Updated:8/20/2016
Start Date:August 2016
Contact:Janet Bergeson, RN MS CCRP
Email:janet.bergeson@usu.edu
Phone:4357978262

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

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).


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.
We found this trial at
1
site
Logan, Utah 84322
Principal Investigator: Michael Lefevre, PhD
Phone: 435-797-8262
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mi
from
Logan, UT
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