HealthyNCT02871596

Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds

A study testing Flavonoids and Flavonoids+Prebiotics in people with Healthy, run by Pharmanex at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Flavonoids and Flavonoids+Prebiotics
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: Aug 2016to Feb 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 17Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Utah State University
Logan, Utah, 84322

Other trials in United States

About this study

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

Conditions: Healthy
Being tested: Placebo, Flavonoids, Flavonoids+Prebiotics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboOther
A combination of maltodextrins and red and blue food colors.
FlavonoidsDietary supplement
A combination of blueberry extract, black current extract, and black rice extract.
Flavonoids+PrebioticsDietary supplement
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.

Study groups in NCT02871596
Study group	Role	What they receive
Placebo,Flavonoids,Flavonoids+Prebiotics	Experimental	Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. Receives: Other: Placebo; Dietary Supplement: Flavonoids; Dietary Supplement: Flavonoids+Prebiotics
Placebo,Flavonoids+Prebiotics,Flavonoids	Experimental	Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. Receives: Other: Placebo; Dietary Supplement: Flavonoids; Dietary Supplement: Flavonoids+Prebiotics
Flavonoids,Placebo,Flavonoids+Prebiotics	Experimental	Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. Receives: Other: Placebo; Dietary Supplement: Flavonoids; Dietary Supplement: Flavonoids+Prebiotics
Flavonoids,Flavonoids+Prebiotics,Placebo	Experimental	Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. Receives: Other: Placebo; Dietary Supplement: Flavonoids; Dietary Supplement: Flavonoids+Prebiotics
Flavonoids+Prebiotics,Placebo,Flavonoids	Experimental	Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. Receives: Other: Placebo; Dietary Supplement: Flavonoids; Dietary Supplement: Flavonoids+Prebiotics
Flavonoids+Prebiotics,Flavonoids,Placebo	Experimental	Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. Receives: Other: Placebo; Dietary Supplement: Flavonoids; Dietary Supplement: Flavonoids+Prebiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: baseline, day 21, day 63, day 105

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Feb 2017

First posted18 Aug 2016 (estimated)
Study startAug 2016
Primary completionFeb 2017
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02871596
Sponsor's protocol ID: 16-PHX-0003
Status last verified: Feb 2017
First submitted: 15 Aug 2016
Last updated: 23 Feb 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds - a Randomized, Placebo-controlled, Double-blind, Cross-over Study
ClinicalTrials.gov ID: NCT02871596
Acronym / sponsor ID: 16-PHX-0003
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: PharmanexIndustry (pharma, biotech, devices)
Collaborators: Utah State University
Study start: Aug 2016
Primary completion: Feb 2017 (actual)
Study completion: Feb 2017 (actual)
First posted: 18 Aug 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Placebo,Flavonoids,Flavonoids+Prebiotics	Experimental	Other: Placebo, Dietary Supplement: Flavonoids, Dietary Supplement: Flavonoids+PrebioticsParticipants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Placebo,Flavonoids+Prebiotics,Flavonoids	Experimental	Other: Placebo, Dietary Supplement: Flavonoids, Dietary Supplement: Flavonoids+PrebioticsParticipants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Flavonoids,Placebo,Flavonoids+Prebiotics	Experimental	Other: Placebo, Dietary Supplement: Flavonoids, Dietary Supplement: Flavonoids+PrebioticsParticipants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Flavonoids,Flavonoids+Prebiotics,Placebo	Experimental	Other: Placebo, Dietary Supplement: Flavonoids, Dietary Supplement: Flavonoids+PrebioticsParticipants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Flavonoids+Prebiotics,Placebo,Flavonoids	Experimental	Other: Placebo, Dietary Supplement: Flavonoids, Dietary Supplement: Flavonoids+PrebioticsParticipants will receive three treatments, for three weeks each, with 21 day washout period between each product.
Flavonoids+Prebiotics,Flavonoids,Placebo	Experimental	Other: Placebo, Dietary Supplement: Flavonoids, Dietary Supplement: Flavonoids+PrebioticsParticipants will receive three treatments, for three weeks each, with 21 day washout period between each product.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (17 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboA combination of maltodextrins and red and blue food colors.	Other	Flavonoids+Prebiotics,Flavonoids,Placebo, Flavonoids+Prebiotics,Placebo,Flavonoids, Flavonoids,Flavonoids+Prebiotics,Placebo, Flavonoids,Placebo,Flavonoids+Prebiotics, Placebo,Flavonoids+Prebiotics,Flavonoids, Placebo,Flavonoids,Flavonoids+Prebiotics
FlavonoidsA combination of blueberry extract, black current extract, and black rice extract.	Dietary supplement	Flavonoids+Prebiotics,Flavonoids,Placebo, Flavonoids+Prebiotics,Placebo,Flavonoids, Flavonoids,Flavonoids+Prebiotics,Placebo, Flavonoids,Placebo,Flavonoids+Prebiotics, Placebo,Flavonoids+Prebiotics,Flavonoids, Placebo,Flavonoids,Flavonoids+Prebiotics
Flavonoids+PrebioticsA combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.	Dietary supplement	Flavonoids+Prebiotics,Flavonoids,Placebo, Flavonoids+Prebiotics,Placebo,Flavonoids, Flavonoids,Flavonoids+Prebiotics,Placebo, Flavonoids,Placebo,Flavonoids+Prebiotics, Placebo,Flavonoids+Prebiotics,Flavonoids, Placebo,Flavonoids,Flavonoids+Prebiotics

Primary outcome

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

3 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Lefevre, PhD principal investigator

Utah State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Flavonoids and Flavonoids+Prebiotics in people with Healthy, run by Pharmanex at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in fecal volatile methyl sulfides at day 21, day 63, day 105 (time frame: baseline, day 21, day 63, day 105). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02871596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.