Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds
NCT ID: NCT02871596
Last Updated: 2017-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
27 participants
INTERVENTIONAL
2016-08-31
2017-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Postbiotics Supplementation, Gut Microbiota Composition, and Exercise-induced Inflammation
NCT06428656
Inflammatory and Metabolic Responses to Long-term Dietary Supplementation With Anthocyanin-rich Blend
NCT04637945
A Randomized, Double-Blind Study to Assess the Effect of a Postbiotic on Oxidative Stress and Exercise Performance
NCT06795425
A Study to Assess the Impact of a Nutritional Supplement on Wellbeing and Nutrient Absorption
NCT06749808
A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience.
NCT06283732
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo,Flavonoids,Flavonoids+Prebiotics
Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Placebo
A combination of maltodextrins and red and blue food colors.
Flavonoids
A combination of blueberry extract, black current extract, and black rice extract.
Flavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
Placebo,Flavonoids+Prebiotics,Flavonoids
Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Placebo
A combination of maltodextrins and red and blue food colors.
Flavonoids
A combination of blueberry extract, black current extract, and black rice extract.
Flavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
Flavonoids,Placebo,Flavonoids+Prebiotics
Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Placebo
A combination of maltodextrins and red and blue food colors.
Flavonoids
A combination of blueberry extract, black current extract, and black rice extract.
Flavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
Flavonoids,Flavonoids+Prebiotics,Placebo
Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Placebo
A combination of maltodextrins and red and blue food colors.
Flavonoids
A combination of blueberry extract, black current extract, and black rice extract.
Flavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
Flavonoids+Prebiotics,Placebo,Flavonoids
Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Placebo
A combination of maltodextrins and red and blue food colors.
Flavonoids
A combination of blueberry extract, black current extract, and black rice extract.
Flavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
Flavonoids+Prebiotics,Flavonoids,Placebo
Participants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Placebo
A combination of maltodextrins and red and blue food colors.
Flavonoids
A combination of blueberry extract, black current extract, and black rice extract.
Flavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
A combination of maltodextrins and red and blue food colors.
Flavonoids
A combination of blueberry extract, black current extract, and black rice extract.
Flavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Utah State University
OTHER
Pharmanex
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Lefevre, PhD
Role: PRINCIPAL_INVESTIGATOR
Utah State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Utah State University
Logan, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16-PHX-0003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.