CompletedNot Applicable

Effects of a Microalgae Extract Dietary Supplement on Gut Health, Anxiety, and Immune Function

United States62 participantsStarted 2024-02-05

Plain-language summary

This study will be conducted to determine the effect of daily Tetrasol consumption in supporting gut health using assessments of gastrointestinal symptoms (GSRS) and bowel habits (BSS) as primary outcome measures. The investigators also intend to explore fecal and blood biomarkers of intestinal permeability/function, determination of anxiety and stress levels through both validated assessments and saliva and blood biomarkers, establishment of intervention safety and tolerability through comprehensive metabolic panels and overall compliance, explore the effects of the intervention on inflammation and acute stress (Cold Presser Test), blood lipid profiles, and gut microbiota composition as secondary outcomes.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy, normal to overweight (BMI of 18.0-29.9) adults between 18-55 years of age with mild to moderate gastrointestinal distress confirmed by one positive response to the Rome IV criteria (Appended). Exclusion Criteria: * BMI \>30.0 or \<18.0 * Smoking or other use of tobacco products * Diagnosed intestinal diseases such as Celiac, Crohn's Disease, Ulcerative Colitis, or Gastrointestinal Cancers * Pregnant or breastfeeding individuals * Regular use of NSAIDs or MAO inhibitors * Clinically diagnosed mental health disorders (clinical depression, bipolar disorder, etc.)

What they're measuring

Deviations from Standard Blood Chemistry as an indicator of safety

Timeframe: 4 Weeks

Gastrointestinal symptoms (GSRS)

Timeframe: 4 weeks

Trial details

NCT IDNCT06425094

SponsorColorado State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-24