CClinicalTrials.gg
Sign In
CompletedNCT02743195Updated Aug 3, 2016

Polyphenol/Prebiotic Blend Effects on GI Health and Microbial Composition

An interventional study of Polyphenol/prebiotic blend in GI Health and Microbial Composition, sponsored by Pharmanex. Completed at 1 site in Canada. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-03.

Sponsored by Pharmanex · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
20 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • GI Health
  • Microbial Composition
03

In context

Lead sponsor

Pharmanex is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Males and Females 20-60 years of age

  2. 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

    Non-heterosexual lifestyles

  3. Subjects with BMI of 29.9-39.9±1 kg/m²
  4. Subjects who agree to maintain their current level of physical activity throughout the trial period
  5. 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
  6. 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
  7. Healthy as determined by laboratory results and medical history
  8. Subjects must agree to comply with study procedures
  9. Has given voluntary, written, informed consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  1. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
  2. Subjects who have used an over-the-counter or prescription laxative medication within 4 weeks prior to baseline
  3. Subjects who have used prebiotic, probiotic supplements or supplemented foods within 4 weeks of enrollment
  4. Use of polyphenol supplements within 4 weeks prior to baseline
  5. Subjects with type I diabetes or uncontrolled type II diabetes
  6. Previous history of gastrointestinal surgery (except appendectomy, hernia repair, or hemorrhoidectomy).
  7. Previous history of gastrointestinal diseases (except hemorrhoids and uncomplicated diverticula), as assessed by ultrasonography, colonoscopy, or rectoscopy, or history of Clostridium difficile-associated diarrhea
  8. Presence of rectal bleeding (unless due to hemorrhoids)
  9. Recent weight-loss (greater than 5 kg in the past month)
  10. Iron deficiency (anemia) diagnosed within 3 months of baseline
  11. Subjects who were smokers within 1 year of baseline
  12. Subjects with active eating disorder
  13. Subjects who have used oral antibiotics within 5 weeks of baseline
  14. Unstable medical condition as determined by principal investigator
  15. 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.
  16. Alcohol abuse or drug abuse within the past 6 months
  17. Consumption of >2 standard alcoholic drinks per day
  18. Use of medicinal marijuana
  19. 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
  20. Participation in a clinical research trial within 30 days prior to baseline
  21. Allergy or sensitivity to the test material's active or inactive ingredients
  22. Allergy or sensitivity to Lactulose or Mannitol
  23. Individuals who are cognitively impaired and/or who are unable to give informed consent
  24. 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
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Other
    Polyphenol/prebiotic blend

    Nutritional 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.

    Dietary Supplement: Polyphenol/prebiotic blend

Interventions

  • Dietary supplementPolyphenol/prebiotic blend
06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, Day 57

Secondary outcomes

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

    Time frame: Baseline, Day 57

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

    Time frame: Baseline, Day 57

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

    Time frame: Baseline, Day 57

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

    Time frame: Baseline, Day 57

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

    Time frame: Baseline, Day 57

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

    Time frame: Baseline, Day 57

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

    Time frame: Baseline, Day 57

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

    Time frame: Baseline, Day 57

  9. Change from baseline in plasma zonulin at day 57

    Time frame: Baseline, Day 57

  10. Change from baseline in Total Cholesterol at day 57

    Time frame: Baseline, Day 57

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

    Time frame: Baseline, Day 57

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

    Time frame: Baseline, Day 57

  13. Change from baseline in Triglycerides at day 57

    Time frame: Baseline, Day 57

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

    Time frame: Baseline, Day 57

  15. Change from baseline in plasma endotoxin at day 57

    Time frame: Baseline, Day 57

Other outcomes

  1. Change from baseline in hematology and clinical chemistry at day 57

    Looking at number of participants with abnormal laboratory values related to treatment

    Time frame: Baseline, Day 57

  2. Change from baseline in kidney and liver function at day 57

    Looking at number of participants with abnormal laboratory values related to treatment

    Time frame: Baseline, Day 57

  3. Change from baseline in electrolytes at day 57

    Time frame: Baseline, Day 57

  4. Change from baseline in heart rate at day 57

    Time frame: Baseline, Day 57

  5. Change from baseline in blood pressure at day 57

    Time frame: Baseline, Day 57

  6. Change from baseline in adverse events at day 57

    Time frame: Baseline, Day 57

07

Study locations

1 site
  • KGK Synergize Inc.
    London, Ontario N6A 5R8, Canada
08

References and documents

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. Erratum In: PLoS One. 2010;5(6). doi: 10.1371/annotation/df45912f-d15c-44ab-8312-e7ec0607604d. 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02743195
Lead sponsor
Pharmanex
Collaborators
KGK Science Inc.
Responsible party
Sponsor
First posted
Apr 19, 2016
Start date
Mar 2016
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Aug 3, 2016

Study contacts

Tetyana Pelipyagina, MD
principal investigator · KGK Science Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Pharmanex

Start the discussion