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Polyphenol/Prebiotic Blend Effects on GI Health and Microbial Composition

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ClinicalTrials.gov Identifier: NCT02743195
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : August 3, 2016
Sponsor:
Collaborator:
KGK Science Inc.
Information provided by (Responsible Party):
Pharmanex

Brief 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.


Condition or disease Intervention/treatment Phase
GI Health Microbial Composition Dietary Supplement: Polyphenol/prebiotic blend Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open Label Study to Investigate a Polyphenol/Prebiotic Blend on Microbial Composition in Otherwise Healthy Obese Males and Females
Study Start Date : March 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline in microbial composition in the feces at day 57 [ Time Frame: Baseline, Day 57 ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Change from baseline in hematology and clinical chemistry at day 57 [ Time Frame: Baseline, Day 57 ]
    Looking at number of participants with abnormal laboratory values related to treatment

  2. Change from baseline in kidney and liver function at day 57 [ Time Frame: Baseline, Day 57 ]
    Looking at number of participants with abnormal laboratory values related to treatment

  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743195


Locations
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Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
Pharmanex
KGK Science Inc.
Investigators
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Principal Investigator: Tetyana Pelipyagina, MD KGK Science Inc.
Publications:

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Responsible Party: Pharmanex
ClinicalTrials.gov Identifier: NCT02743195    
Other Study ID Numbers: 16-PHX-0001
16PMHN ( Other Identifier: KGK Synergize Inc. )
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No