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Completed

NCT Number: NCT02871596

Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds

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).

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Utah State University

Logan, Utah, 84322, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Other

A combination of maltodextrins and red and blue food colors.

Flavonoids

Dietary Supplement

A combination of blueberry extract, black current extract, and black rice extract.

Flavonoids+Prebiotics

Dietary Supplement

A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.

Primary outcomes

  1. 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 outcomes

  1. Change from baseline in all fecal VOCs at day 21, day 63, day 105

    Time frame: baseline, day 21, day 63, day 105

  2. Change from baseline fecal short chain fatty acids at day 21, day 63, day 105

    Time frame: baseline, day 21, day 63, day 105

  3. Change from baseline fecal microbiota composition at day 21, day 63, day 105

    Time frame: baseline, day 21, day 63, day 105

Sponsors and collaborators

Lead sponsor

Pharmanex

Industry

Collaborators

  • Utah State University

Registry information

Official study title

Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds - a Randomized, Placebo-controlled, Double-blind, Cross-over Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2016
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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