Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds
1 other identifier
interventional
27
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 15, 2016
CompletedFirst Posted
Study publicly available on registry
August 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFebruary 23, 2017
February 1, 2017
6 months
August 15, 2016
February 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (6)
Placebo,Flavonoids,Flavonoids+Prebiotics
EXPERIMENTALParticipants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Placebo,Flavonoids+Prebiotics,Flavonoids
EXPERIMENTALParticipants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Flavonoids,Placebo,Flavonoids+Prebiotics
EXPERIMENTALParticipants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Flavonoids,Flavonoids+Prebiotics,Placebo
EXPERIMENTALParticipants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Flavonoids+Prebiotics,Placebo,Flavonoids
EXPERIMENTALParticipants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Flavonoids+Prebiotics,Flavonoids,Placebo
EXPERIMENTALParticipants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Interventions
A combination of maltodextrins and red and blue food colors.
A combination of blueberry extract, black current extract, and black rice extract.
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmanexlead
- Utah State Universitycollaborator
Study Sites (1)
Utah State University
Logan, Utah, 84322, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Lefevre, PhD
Utah State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2016
First Posted
August 18, 2016
Study Start
August 1, 2016
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
February 23, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share