60 Participants Needed

Microalgae Extract for Anxiety and Gut Health

(Tetrasol Trial)

TL
SA
Overseen BySarah A Johnson, RDN,MS,PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a microalgae extract dietary supplement can aid anxiety and gut health. Researchers aim to determine if daily intake of this supplement improves symptoms such as stomach discomfort and stress levels. Participants will receive either the microalgae supplement or a placebo (a pill with no active ingredient) to compare effects. The trial seeks adults who frequently experience mild to moderate stomach issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you regularly use NSAIDs (a type of pain reliever) or MAO inhibitors (a type of antidepressant).

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that taking microalgae extract daily is generally safe and easy for most people to handle. In one study, participants used the supplement for four weeks without any major side effects. This suggests that the microalgae extract, similar to the one tested in this trial, is likely safe for people. This trial is in the early stages and primarily focuses on safety. While no serious problems have emerged, the trial will help confirm how well people can tolerate the extract.12345

Why do researchers think this study treatment might be promising?

Unlike standard treatments for anxiety and gut health, which often involve pharmaceuticals like SSRIs or probiotics, this new approach uses microalgae extract. Researchers are excited about this treatment because it harnesses a natural product called Tetrasol extract, which might offer benefits with potentially fewer side effects. This extract is packed with nutrients and bioactive compounds, possibly offering a dual benefit of calming anxiety while promoting gut health. Plus, the use of a natural supplement could appeal to those looking for a holistic alternative to traditional medications.

What evidence suggests that this treatment might be an effective treatment for anxiety and gut health?

Research has shown that the microalgae extract, Tetrasol, might improve gut health and reduce anxiety. In this trial, participants will receive either microalgae extract capsules or a placebo. One study found that people who took Tetrasol daily for four weeks experienced fewer stomach problems. The supplement proved to be safe and easy to take. Early findings suggest that this microalgae extract might also aid mental health by reducing stress and anxiety. While more research is needed, these early results are promising for those seeking to support their gut and mental well-being.12346

Who Is on the Research Team?

TL

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.
See 3 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Microalgae extract capsulesExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials
138
Recruited
38,200+

Micropyt

Collaborator

Trials
1
Recruited
60+

Citations

Effects of Supplementation with Microalgae Extract ...Results: Daily supplementation for four weeks with TOME was safe and well tolerated in the study population. In addition, TOME significantly reduced GSRS global ...
Effects of a Microalgae Extract Dietary Supplement on Gut ...This study will be conducted to determine the effect of daily Tetrasol consumption in supporting gut health using assessments of gastrointestinal symptoms ( ...
Microalgae Extract for Anxiety and Gut Health (Tetrasol Trial)This study will be conducted to determine the effect of daily Tetrasol consumption in supporting gut health using assessments of gastrointestinal symptoms ...
Effects of Supplementation with Microalgae Extract from ...Results: Daily supplementation for four weeks with TOME was safe and well tolerated in the study population. In addition, TOME significantly ...
Microalgae extract may improve gut disturbances and ...A microalgae supplement marketed as ZenGut may improve gastrointestinal symptoms and promote positive mental health effects, according to new research.
Oxidative Stress, Gut Bacteria, and Microalgae: A Holistic ...This review explores the multifaceted role of oxidative stress in IBD and highlights the therapeutic potential of microalgae-derived compounds.
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