Microalgae Extract for Anxiety and Gut Health

(Tetrasol Trial)

Overseen By Sarah A Johnson, RDN,MS,PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Colorado State University

Must not be taking: NSAIDs, MAO inhibitors

Disqualifiers: BMI >30 or <18, Smoking, Intestinal diseases, Pregnant, Mental health disorders, others

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Tiffany L Weir, MSc,PhD

Principal Investigator

Colorado State University

Are You a Good Fit for This Trial?

This trial is for individuals experiencing anxiety disorders or gastrointestinal issues. Participants should be interested in testing a dietary supplement made from microalgae extract to see if it helps with gut health and reduces anxiety and stress.

Exclusion Criteria

BMI >30.0 or <18.0

I have been diagnosed with a disease of the intestines like Celiac, Crohn's Disease, Ulcerative Colitis, or a type of gastrointestinal cancer.

I regularly take NSAIDs or MAO inhibitors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants consume a microalgae-based ingredient or placebo for 4 weeks with assessments of gastrointestinal symptoms, anxiety, stress, and biomarkers

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Microalgae Extract Dietary Supplement

Trial Overview The study tests the effects of Tetradesmus Dimorphus (a type of microalgae) capsules on gut health, anxiety, and immune function compared to placebo. It measures stomach symptoms, bowel habits, blood and fecal markers, stress levels, safety/tolerability, inflammation response, blood fats, and changes in gut bacteria.

How Is the Trial Designed?

Group I: Microalgae extract capsules Experimental Treatment 1 Intervention

Tetrasol extract, maltodextrin, vegetable magnesium stearate, dicalcium phosphate, hydrogenated rapeseed oil, hydroxypropylmethylcellulose

Group II: Placebo Placebo Group 1 Intervention

maltodextrin, vegetable magnesium stearate

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

Micropyt

Collaborator

Trials

1

Recruited

60+