Polyphenol/Prebiotic Blend Effects on GI Health and Microbial Composition

Study Overview
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Brief Summary
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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.

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

Conditions
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GI Health, Microbial Composition

Intervention / Treatment
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* Dietary Supplement: Polyphenol/prebiotic blend


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Polyphenol/prebiotic blend<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in microbial composition in the feces at day 57 |  | Baseline, Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change from baseline in IL-12p70 in the feces at day 57 |  | Baseline, Day 57 | 
| Change from baseline in TNFα in the feces at day 57 |  | Baseline, Day 57 | 
| Change from baseline in urine sugar test for gut permeability at day 57 |  | Baseline, Day 57 | 
| Change from baseline in plasma zonulin at day 57 |  | Baseline, Day 57 | 
| Change from baseline in Total Cholesterol at day 57 |  | Baseline, Day 57 | 
| Change from baseline in HDL-C at day 57 |  | Baseline, Day 57 | 
| Change from baseline in LDL-C at day 57 |  | Baseline, Day 57 | 
| Change from baseline in Triglycerides at day 57 |  | Baseline, Day 57 | 
| Change from baseline in weekly mean of daily Bristol Stool Scale (BSS) scores at day 57 |  | Baseline, Day 57 | 
| Change from baseline in plasma endotoxin at day 57 |  | Baseline, Day 57 |