Anxiety Clinical Trial
— TetrasolOfficial title:
Effects of a Microalgae Extract Dietary Supplement on Gut Health, Anxiety, and Immune Function
This study will be conducted to determine the effect of daily Tetradesmus Dimorphus by 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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | May 24, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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.) |
Country | Name | City | State |
---|---|---|---|
United States | Food and Nutrition Clinical Research Lab(FNCRL), Colorado State University | Fort Collins | Colorado |
Lead Sponsor | Collaborator |
---|---|
Colorado State University |
United States,
Avila-Roman J, Talero E, Alcaide A, Reyes Cde L, Zubia E, Garcia-Maurino S, Motilva V. Preventive effect of the microalga Chlamydomonas debaryana on the acute phase of experimental colitis in rats. Br J Nutr. 2014 Oct 14;112(7):1055-64. doi: 10.1017/S0007114514001895. Epub 2014 Sep 5. — View Citation
Avila-Roman J, Talero E, Rodriguez-Luna A, Garcia-Maurino S, Motilva V. Anti-inflammatory effects of an oxylipin-containing lyophilised biomass from a microalga in a murine recurrent colitis model. Br J Nutr. 2016 Dec;116(12):2044-2052. doi: 10.1017/S0007114516004189. Epub 2016 Dec 27. — View Citation
Merchant RE, Andre CA. A review of recent clinical trials of the nutritional supplement Chlorella pyrenoidosa in the treatment of fibromyalgia, hypertension, and ulcerative colitis. Altern Ther Health Med. 2001 May-Jun;7(3):79-91. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effect of daily Tetradesmus Dimorphus by Tetrasol consumption in supporting gut health using assessments of gastrointestinal symptoms (GSRS) and bowel habits (BSS) | This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) & visit 4(week 4) to analyze. | 4weeks | |
Primary | Exploration fecal and blood biomarkers of intestinal permeability/function | This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) & visit 4(week 4) to analyze. | 4 Weeks | |
Primary | Determination of anxiety and stress levels through both validated assessments and saliva and blood biomarkers | This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) & visit 4(week 4) to analyze. | 4 Weeks | |
Primary | Establishment of intervention safety and tolerability through comprehensive metabolic panels and overall compliance | This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) & visit 4(week 4) to analyze. | 4 Weeks | |
Primary | Exploration of the effects of the intervention on inflammation and acute stress (Cold Presser Test), blood lipid profiles, and gut microbiota composition | This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) & visit 4(week 4) to analyze. | 4 Weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
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