Healthy
Conditions
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).
Interventions
OTHERPlacebo
A combination of maltodextrins and red and blue food colors.
DIETARY_SUPPLEMENTFlavonoids
A combination of blueberry extract, black current extract, and black rice extract.
DIETARY_SUPPLEMENTFlavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
Sponsors
Utah State University
Pharmanex
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in fecal volatile methyl sulfides at day 21, day 63, day 105 | baseline, day 21, day 63, day 105 | assessed by gas chromatograph - mass spectrometry (GC-MS) headspace analysis |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed