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

NCT04735809 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-02-03

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Whole Cell Algae Fermentate

Contains at minimum 50% Beta Glucan

DIETARY_SUPPLEMENT

Placebo

microcrystalline cellulose

Sponsors & Collaborators

  • Kemin Foods LC

    lead INDUSTRY

Principal Investigators

  • Andrea Lawless, MD · Biofortis Innovation Services

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2019-12-20
Completion
2020-06-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04735809 on ClinicalTrials.gov