Efficacy of a Whole Cell Algae Fermentate on Gut Health and Overall Immune Function in Healthy Ad… (NCT04735809) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of a Whole Cell Algae Fermentate on Gut Health and Overall Immune Function in Healthy Adults With Mild Gastrointestinal Issues
United States70 participantsStarted 2019-03-21
Plain-language summary
The objective of the current study is to evaluate the effect of whole cell fermentate on gut health, including GI system function, such as supporting consistency and regularity of bowel habits, as well as changes in microbiota. The role of the GI system can also be extended to immune regulation because approximately 70% of the entire immune system in the body is located around the gut. Thus, the health and wellbeing of the gut can have a great impact on whole-body health. Therefore, this study will assess the effect on overall immune function.
Who can participate
Age range21 Years – 60 Years
SexALL
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Inclusion criteria
✓. Subject is a male or female, 21-60 years of age
✓. Subject has a BMI of 18.5-34.9 kg/m2
✓. Subject reports having mild GI issues
✓. Subject is willing and able to comply with the collection and storage requirements of the stool samples
✓. Subject has internet access via computer, phone or other device and is able to maintain internet access throughout the trial in order to complete online daily questionnaires
✓. Subject is a non-user of all tobacco, smoking products and nicotine products
✓. Subject is willing to maintain physical activity patterns, body weight, supplements/medications, sleep patterns, and habitual diet throughout the trial.
✓. Subject has no health conditions that would prevent him from fulfilling the study requirements 9 Subject understands the study procedures and signs forms providing informed consent to participate in the study
. Subject has an abnormal laboratory test result(s) of clinical importance at Visit 1
✕. Subject has a clinically important GI condition that would potentially interfere with the evaluation of the study product
✕. 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
✕. Subject has a known allergy, intolerance, or sensitivity to any of the ingredients in the study products
✕. Subject has extreme dietary habits (e.g., Atkins diet, very high protein, very high fiber)
✕. Subject has uncontrolled hypertension
✕. Subject has a recent (within 6 weeks of Visit 1) diarrhea (defined as ≥3 loose or liquid stools/d)
✕. Subject has participated in colonoscopy or colonoscopy preparation within 3 months prior to Visit 1