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

NCT04735809 | Completed

• 1 other identifier: BIO-1901
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Gastrointestinal Dysfunction; Cold Symptom; Flu Symptom

Outcome Measures

Primary Outcomes (3)

• Gastrointestinal symptom

  Gastrointestinal Tolerability Questionnaire

  After 4 weeks of each test period

• Gastrointestinal ease and consistency

  Bristol Stool Scale

  After 4 weeks of each test period

• Cold/Flu Symptoms

  Wisconsin Upper Respiratory Symptom Survey

  After 4 weeks of each test period

Secondary Outcomes (5)

• Fecal Microbiome

  After 4 weeks of each test period

• Fecal biomarker 1

  After 4 weeks of each test period

• Fecal biomarker 2

  After 4 weeks of each test period

• Stress Questionnaire

  After 4 weeks of each test period

• Quality of Life Questionnaire

  After 4 weeks of each test period

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Microcystalline Cellulose

Dietary Supplement: Placebo

Treatment

EXPERIMENTAL

Whole Cell Algae Fermentate

Dietary Supplement: Whole Cell Algae Fermentate

Interventions

Whole Cell Algae Fermentate DIETARY_SUPPLEMENT

Contains at minimum 50% Beta Glucan

Treatment

Placebo DIETARY_SUPPLEMENT

microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Kemin Foods LC: lead

Study Sites (1)

Biofortis Innovation Services

Addison, Illinois, 60101, United States

Location

Study Officials

• Andrea Lawless, MD

  Biofortis Innovation Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Placebo-Controlled, Crossover Study

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: February 3, 2021
• Study Start: March 21, 2019
• Primary Completion: December 20, 2019
• Study Completion: June 20, 2020
• Last Updated: February 3, 2021

Record last verified: 2019-03

Locations

US (1)