Polyphenol/Prebiotic Blend Effects on GI Health and Microbial Composition

NCT02743195 | Completed

• 2 other identifiers: 16-PHX-000116PMHN
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

GI Health; Microbial Composition

Outcome Measures

Primary Outcomes (1)

• Change from baseline in microbial composition in the feces at day 57

  Baseline, Day 57

Secondary Outcomes (15)

• Change from baseline in calprotectin in the feces at day 57

  Baseline, Day 57

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

  Baseline, Day 57

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

  Baseline, Day 57

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

  Baseline, Day 57

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

  Baseline, Day 57

Other Outcomes (6)

• Change from baseline in hematology and clinical chemistry at day 57

  Baseline, Day 57

• Change from baseline in kidney and liver function at day 57

  Baseline, Day 57

• Change from baseline in electrolytes at day 57

  Baseline, Day 57

Study Arms (1)

Polyphenol/prebiotic blend

OTHER

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

Polyphenol/prebiotic blend DIETARY_SUPPLEMENT

Polyphenol/prebiotic blend

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Pharmanex: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Related Publications (7)

• 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.

  PMID: 20498852 BACKGROUND

• 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.

  PMID: 23489554 BACKGROUND

• 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.

  PMID: 23768554 BACKGROUND

• 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.

  PMID: 17634269 BACKGROUND

• 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.

  PMID: 22060186 BACKGROUND

• 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.

  PMID: 23883473 BACKGROUND

• 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.

  PMID: 25075866 BACKGROUND

MeSH Terms

Interventions

Polyphenols

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tetyana Pelipyagina, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 19, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 3, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)