Effects of a microalgae extract on gut health and anxiety
Effects of a Microalgae Extract Dietary Supplement on Gut Health, Anxiety, and Immune Function
PHASE1 · Colorado State University · NCT06425094
This study is testing if taking a daily microalgae extract called Tetrasol can improve gut health and reduce anxiety in people.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Colorado State University (other) |
| Locations | 1 site (Fort Collins, Colorado) |
| Trial ID | NCT06425094 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of daily consumption of Tetrasol, a microalgae extract, on gut health, anxiety, and immune function. Participants will be assessed for gastrointestinal symptoms and bowel habits, while also exploring biomarkers related to intestinal permeability, anxiety, and stress levels. The study employs a double-blind, placebo-controlled design, with random assignment of participants to either the Tetrasol or placebo group. The goal is to gather preliminary data to inform future larger-scale studies on this dietary supplement.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-55 with a BMI between 18.0 and 29.9 who experience mild to moderate gastrointestinal distress.
Not a fit: Patients with significant gastrointestinal diseases, severe obesity, or diagnosed mental health disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary approach to improve gut health and reduce anxiety symptoms in individuals with mild to moderate gastrointestinal distress.
How similar studies have performed: While this is the first human study of Tetrasol, similar dietary interventions have shown promise in improving gut health and mental well-being.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Fort Collins, Colorado
- Food and Nutrition Clinical Research Lab(FNCRL), Colorado State University — Fort Collins, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Tiffany L Weir, MSc,PhD — Colorado State University
- Study coordinator: Tiffany L Weir, MSc,PhD
- Email: tiffany.weir@colostate.edu
- Phone: (970) 491-4631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastrointestinal Problem, Anxiety, Stress, Gastrointestinal Symptoms, Tetrasol, Bowel Habits