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GI HealthNCT02743195

Polyphenol/Prebiotic Blend Effects on GI Health and Microbial Composition

A study testing Polyphenol/prebiotic blend in people with GI Health and Microbial Composition, run by Pharmanex at 1 site in Canada.

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 gastrointestinal (GI) ecosystem is a complex network of bacterial cells, host cells and tissues that change with age. Fewer numbers and less diversity of beneficial bacteria and greater number and diversity of non-beneficial bacteria occurs with age and conditions associated with accelerated aging (i.e. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
GI Health, Microbial Composition
What is being tested?
Polyphenol/prebiotic blend
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteCanada
Study dates
Mar 2016to Jun 2016
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 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males and Females 20-60 years of age
  • Female subjects of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
  • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
  • Double-barrier methods
  • Non-hormonal intrauterine devices
  • Vasectomy of partner
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  • Non-heterosexual lifestyles
  • Subjects with BMI of 29.9-39.9±1 kg/m²
  • Subjects who agree to maintain their current level of physical activity throughout the trial period
  • Subjects who agree to discontinue the use or pre- and probiotic and/or polyphenol supplements from four weeks prior to baseline and for the duration of the study
  • Subjects who agree to discontinue foods containing anthocyanins (such as blueberries, blackberries, cherries, grapes, grape juice, pomegranate, raspberries, huckleberries, strawberries, and wine) from two weeks prior to baseline and for the duration of the study
  • Healthy as determined by laboratory results and medical history
  • Subjects must agree to comply with study procedures
  • Has given voluntary, written, informed consent to participate in the study

Who cannot join

  • Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
  • Subjects who have used an over-the-counter or prescription laxative medication within 4 weeks prior to baseline
  • Subjects who have used prebiotic, probiotic supplements or supplemented foods within 4 weeks of enrollment
  • Use of polyphenol supplements within 4 weeks prior to baseline
  • Subjects with type I diabetes or uncontrolled type II diabetes
  • Previous history of gastrointestinal surgery (except appendectomy, hernia repair, or hemorrhoidectomy).
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  • Previous history of gastrointestinal diseases (except hemorrhoids and uncomplicated diverticula), as assessed by ultrasonography, colonoscopy, or rectoscopy, or history of Clostridium difficile-associated diarrhea
  • Presence of rectal bleeding (unless due to hemorrhoids)
  • Recent weight-loss (greater than 5 kg in the past month)
  • Iron deficiency (anemia) diagnosed within 3 months of baseline
  • Subjects who were smokers within 1 year of baseline
  • Subjects with active eating disorder
  • Subjects who have used oral antibiotics within 5 weeks of baseline
  • Unstable medical condition as determined by principal investigator
  • History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years of diagnosis are acceptable.
  • Alcohol abuse or drug abuse within the past 6 months
  • Consumption of >2 standard alcoholic drinks per day
  • Use of medicinal marijuana
  • Use of anti-inflammatory medications, more than once per week or if prescribed by a physician, 4 weeks prior to randomization and for the duration of the study
  • Participation in a clinical research trial within 30 days prior to baseline
  • Allergy or sensitivity to the test material's active or inactive ingredients
  • Allergy or sensitivity to Lactulose or Mannitol
  • Individuals who are cognitively impaired and/or who are unable to give informed consent
  • Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • KGK Synergize Inc.

    London, Ontario, N6A 5R8

Other trials in Canada

About this study

Official title: An Open Label Study to Investigate a Polyphenol/Prebiotic Blend on Microbial Composition in Otherwise Healthy Obese Males and Females

The gastrointestinal (GI) ecosystem is a complex network of bacterial cells, host cells and tissues that change with age. Fewer numbers and less diversity of beneficial bacteria and greater number and diversity of non-beneficial bacteria occurs with age and conditions associated with accelerated aging (i.e. obesity, high fat diet)(1,2). This imbalance of the microbiota contributes to increased inflammation of the gastrointestinal lining and changes to the integrity of the intestinal cell wall.

Prebiotics, such as non-digestible carbohydrates, can induce the growth or activity microorganisms that contribute to the well-being of the host. Recent studies have shown that prebiotic treatment can have beneficial effects on glucose levels, lipid metabolism, and inflammatory markers in an obese population(3). The polyphenol blend is rich in anthocyanins, which is a unique subgroup of flavonoids that have been demonstrated to impact the microbiome and have anti-inflammatory properties(4,5,6,7). This open-label study will assess the benefits of a prebiotic and polyphenol blend in healthy obese adults.

Being tested
Polyphenol/prebiotic blend

What participants receive

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

  • Polyphenol/prebiotic blendDietary supplement

Study groups in NCT02743195
Study groupRoleWhat they receive
Polyphenol/prebiotic blendOtherNutritional Supplement. Active ingredients include: Inulin, Fructooligosaccharides, Polyphenol blend of anthocyanin sources--Blueberry extract, Black Currant extract, Black Rice extract. Participants will be instructed to consume one sachet of powder product every morning with breakfast by mixing into beverage or food of choice.
Receives: Dietary Supplement: Polyphenol/prebiotic blend

What is being measured

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

  1. Change from baseline in microbial composition in the feces at day 57

    Measured: Baseline, Day 57

Secondary outcomes (15)

  1. Change from baseline in calprotectin in the feces at day 57

    Measured: Baseline, Day 57

  2. Change from baseline in IL-6 in the feces at day 57

    Measured: Baseline, Day 57

  3. Change from baseline in IL-8 in the feces at day 57

    Measured: Baseline, Day 57

  4. Change from baseline in IL-10 in the feces at day 57

    Measured: Baseline, Day 57

  5. Change from baseline in IL-1β in the feces at day 57

    Measured: Baseline, Day 57

  6. Change from baseline in IL-12p70 in the feces at day 57

    Measured: Baseline, Day 57

  7. Change from baseline in TNFα in the feces at day 57

    Measured: Baseline, Day 57

  8. Change from baseline in urine sugar test for gut permeability at day 57

    Measured: Baseline, Day 57

  9. Change from baseline in plasma zonulin at day 57

    Measured: Baseline, Day 57

  10. Change from baseline in Total Cholesterol at day 57

    Measured: Baseline, Day 57

  11. Change from baseline in HDL-C at day 57

    Measured: Baseline, Day 57

  12. Change from baseline in LDL-C at day 57

    Measured: Baseline, Day 57

  13. Change from baseline in Triglycerides at day 57

    Measured: Baseline, Day 57

  14. Change from baseline in weekly mean of daily Bristol Stool Scale (BSS) scores at day 57

    Measured: Baseline, Day 57

  15. Change from baseline in plasma endotoxin at day 57

    Measured: Baseline, Day 57

Timeline

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

  1. First posted19 Apr 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02743195
Sponsor's protocol ID
16-PHX-0001
Other IDs
16PMHN
Status last verified
Aug 2016
First submitted
11 Apr 2016
Last updated
3 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Biagi E, Nylund L, Candela M, Ostan R, Bucci L, Pini E, Nikkila J, Monti D, Satokari R, Franceschi C, Brigidi P, De Vos W. Through ageing, and beyond: gut microbiota and inflammatory status in seniors and centenarians. PLoS One. 2010 May 17;5(5):e10667. doi: 10.1371/journal.pone.0010667.

    PubMed 20498852

  • Duncan SH, Flint HJ. Probiotics and prebiotics and health in ageing populations. Maturitas. 2013 May;75(1):44-50. doi: 10.1016/j.maturitas.2013.02.004. Epub 2013 Mar 11.

    PubMed 23489554

  • Everard A, Cani PD. Diabetes, obesity and gut microbiota. Best Pract Res Clin Gastroenterol. 2013 Feb;27(1):73-83. doi: 10.1016/j.bpg.2013.03.007.

    PubMed 23768554

  • Karlsen A, Retterstol L, Laake P, Paur I, Bohn SK, Sandvik L, Blomhoff R. Anthocyanins inhibit nuclear factor-kappaB activation in monocytes and reduce plasma concentrations of pro-inflammatory mediators in healthy adults. J Nutr. 2007 Aug;137(8):1951-4. doi: 10.1093/jn/137.8.1951.

    PubMed 17634269

  • Vendrame S, Guglielmetti S, Riso P, Arioli S, Klimis-Zacas D, Porrini M. Six-week consumption of a wild blueberry powder drink increases bifidobacteria in the human gut. J Agric Food Chem. 2011 Dec 28;59(24):12815-20. doi: 10.1021/jf2028686. Epub 2011 Nov 18.

    PubMed 22060186

  • Guglielmetti S, Fracassetti D, Taverniti V, Del Bo' C, Vendrame S, Klimis-Zacas D, Arioli S, Riso P, Porrini M. Differential modulation of human intestinal bifidobacterium populations after consumption of a wild blueberry (Vaccinium angustifolium) drink. J Agric Food Chem. 2013 Aug 28;61(34):8134-40. doi: 10.1021/jf402495k. Epub 2013 Aug 19.

    PubMed 23883473

  • Taverniti V, Fracassetti D, Del Bo' C, Lanti C, Minuzzo M, Klimis-Zacas D, Riso P, Guglielmetti S. Immunomodulatory effect of a wild blueberry anthocyanin-rich extract in human Caco-2 intestinal cells. J Agric Food Chem. 2014 Aug 20;62(33):8346-51. doi: 10.1021/jf502180j. Epub 2014 Aug 8.

    PubMed 25075866

Questions about this trial

What is this clinical trial studying?

A study testing Polyphenol/prebiotic blend in people with GI Health and Microbial Composition, run by Pharmanex at 1 site in Canada.

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 14 inclusion and 24 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 3 Aug 2016. 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 Canada. 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 microbial composition in the feces at day 57 (time frame: Baseline, Day 57). 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 NCT02743195, which also lists 7 linked publications.

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 3 Aug 2016.

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