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 |
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).
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
Click here to add this to my saved trials