Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds

Overview

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).

Full Title of Study: “Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds – a Randomized, Placebo-controlled, Double-blind, Cross-over Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2017

Interventions

  • Other: Placebo
    • A combination of maltodextrins and red and blue food colors.
  • Dietary Supplement: Flavonoids
    • A combination of blueberry extract, black current extract, and black rice extract.
  • Dietary Supplement: Flavonoids+Prebiotics
    • A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.

Arms, Groups and Cohorts

  • Experimental: Placebo,Flavonoids,Flavonoids+Prebiotics
    • Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.
  • Experimental: Placebo,Flavonoids+Prebiotics,Flavonoids
    • Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.
  • Experimental: Flavonoids,Placebo,Flavonoids+Prebiotics
    • Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.
  • Experimental: Flavonoids,Flavonoids+Prebiotics,Placebo
    • Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.
  • Experimental: Flavonoids+Prebiotics,Placebo,Flavonoids
    • Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.
  • Experimental: Flavonoids+Prebiotics,Flavonoids,Placebo
    • Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in fecal volatile methyl sulfides at day 21, day 63, day 105
    • Time Frame: baseline, day 21, day 63, day 105
    • assessed by gas chromatograph – mass spectrometry (GC-MS) headspace analysis

Secondary Measures

  • Change from baseline in all fecal VOCs at day 21, day 63, day 105
    • Time Frame: baseline, day 21, day 63, day 105
  • Change from baseline fecal short chain fatty acids at day 21, day 63, day 105
    • Time Frame: baseline, day 21, day 63, day 105
  • Change from baseline fecal microbiota composition at day 21, day 63, day 105
    • Time Frame: baseline, day 21, day 63, day 105

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pharmanex
  • Collaborator
    • Utah State University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael Lefevre, PhD, Principal Investigator, Utah State University

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