Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Dietary supplement: Flavonoids; Dietary supplement: Flavonoids+Prebiotics

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Logan, Utah, United States, 84322
      • Utah State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo,Flavonoids,Flavonoids+Prebiotics; Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.	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.
Experimental: Placebo,Flavonoids+Prebiotics,Flavonoids; Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.	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.
Experimental: Flavonoids,Placebo,Flavonoids+Prebiotics; Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.	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.
Experimental: Flavonoids,Flavonoids+Prebiotics,Placebo; Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.	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.
Experimental: Flavonoids+Prebiotics,Placebo,Flavonoids; Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.	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.
Experimental: Flavonoids+Prebiotics,Flavonoids,Placebo; Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Pharmanex
• Collaborators: Utah State University

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: August 15, 2016
• First Posted (Estimate): August 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 21, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 16-PHX-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO