Clinical trial NCT02871596: Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds
Official title: Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds - a Randomized, Placebo-controlled, Double-blind, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
Collaborators: name: Utah State University
First posted: 2016-08-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in fecal volatile methyl sulfides at day 21, day 63, day 105
timeFrame: baseline, day 21, day 63, day 105
Secondary outcomes:
measure: Change from baseline in all fecal VOCs at day 21, day 63, day 105
timeFrame: baseline, day 21, day 63, day 105
measure: Change from baseline fecal short chain fatty acids at day 21, day 63, day 105
timeFrame: baseline, day 21, day 63, day 105
measure: Change from baseline fecal microbiota composition at day 21, day 63, day 105
timeFrame: baseline, day 21, day 63, day 105
Other outcomes:
Locations:
city: Logan
country: United States
facility: Utah State University
state: Utah
Study officials:
affiliation: Utah State University
name: Michael Lefevre, PhD
role: PRINCIPAL_INVESTIGATOR
References: