Polyphenol/Prebiotic Blend Effects on GI Health and Microbial Composition

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