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

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy, Gastrointestinal Dysfunction, Cold Symptom, Flu Symptom

In brief

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.

Key facts

Study ID: NCT04735809
Run by: Kemin Foods LC
People needed: 70
Starts: 2019-03-21
Expected to finish: 2020-06-20
Last updated by the study team: 2021-02-03

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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
Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer
Subject has a history of bariatric surgery for weight reducing purposes
Subject has had a weight gain or loss of ≥5% body weight within 6 months of Visit 1
Subject has experienced any major trauma or any other surgical event within three months of Visit 1
Subject has any signs or symptoms of an active infection (including diarrhea) of clinical relevance within 5 days of Visit 1
Subject has used antibiotics within 3 months of Visit 1 or throughout study period
Subject has used medications (over-the-counter or prescription) or dietary supplements known to influence GI function
Subject has used medications or supplements known to influence immune responses
Subject is a regular user (>3 times/week) of prescribed anti-inflammatory medications within 30 d of Visit 1
Subject is a regular user (i.e., >1 time per month) of allergy medications
Subject has used weight-loss medications
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
Subject has a recent history of (within 12 months of screening; Visit 1; week -1) or strong potential for alcohol or substance abuse
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

Where it is running

Biofortis Innovation Services — Addison, Illinois, United States

Full record on ClinicalTrials.gov

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