Efficacy of a Whole Cell Algae Fermentate on Gut Health and Overall Immune Function in Healthy Adults With Mild Gastrointestinal Issues

Exclusion Criteria

• •1. Subject has an abnormal laboratory test result(s) of clinical importance at Visit 1
• •2. Subject has a clinically important GI condition that would potentially interfere with the evaluation of the study product
• •3. Subject has a history or presence of uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including type 1 and type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including unstable depression and/or unstable anxiety disorders) or biliary disorders
• •4. Subject has a known allergy, intolerance, or sensitivity to any of the ingredients in the study products
• •5. Subject has extreme dietary habits (e.g., Atkins diet, very high protein, very high fiber)
• •6. Subject has uncontrolled hypertension
• •7. Subject has a recent (within 6 weeks of Visit 1) diarrhea (defined as ≥3 loose or liquid stools/d)
• •8. Subject has participated in colonoscopy or colonoscopy preparation within 3 months prior to Visit 1
• •9. Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer
• •10. Subject has a history of bariatric surgery for weight reducing purposes
• •11. Subject has had a weight gain or loss of ≥5% body weight within 6 months of Visit 1
• •12. Subject has experienced any major trauma or any other surgical event within three months of Visit 1
• •13. Subject has any signs or symptoms of an active infection (including diarrhea) of clinical relevance within 5 days of Visit 1
• •14. Subject has used antibiotics within 3 months of Visit 1 or throughout study period
• •15. Subject has used medications (over-the-counter or prescription) or dietary supplements known to influence GI function
• •16. Subject has used medications or supplements known to influence immune responses
• •17. Subject is a regular user (\>3 times/week) of prescribed anti-inflammatory medications within 30 d of Visit 1
• •18. Subject is a regular user (i.e., \>1 time per month) of allergy medications
• •19. Subject has used weight-loss medications
• •20. Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period
• •21. Subject has a recent history of (within 12 months of screening; Visit 1; week -1) or strong potential for alcohol or substance abuse
• •22. Individual has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk