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

NCT06425094 | Completed DMC

• 1 other identifier: 5162
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Problem; Anxiety; Stress; Gastrointestinal Symptoms

Keywords

Tetrasol; Gastrointestinal Symptoms; Anxiety; Stress; Gastrointestinal Problem; Bowel Habits

Outcome Measures

Primary Outcomes (2)

• Deviations from Standard Blood Chemistry as an indicator of safety

  Product safety will be assessed using the Piccolo Xpress Comprehensive Metabolic Panel that is conducted on samples collected at visit 2 (baseline), visit 3 (Week 2) \& visit 4 (Week 4) for deviations from standard reference ranges for analytes in this panel.

  4 Weeks

• Gastrointestinal symptoms (GSRS)

  Gastrointestinal symptoms will be reported using the Gastrointestinal Symptom Rating Score (GSRS) at visit 2(baseline), visit 3 (Week 2) \& visit 4 (Week 4).

  4 weeks

Secondary Outcomes (7)

• Bowel movement regularity

  4 Weeks

• Gut microbiota composition

  4 Weeks

• Short Chain Fatty Acid quantification in feces

  4 Weeks

• Hemodynamics during acute stress

  4 Weeks

• Anxiety levels determined by GAD-7 self-assessments.

  4 Weeks

Other Outcomes (6)

• Salivary a-amylase

  4 Weeks

• Brain-derived Neurotrophic factor

  4 weeks

• Cortisol

  4 Weeks

Study Arms (2)

Microalgae extract capsules

EXPERIMENTAL

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

Dietary Supplement: Microalgae Extract Capsules

Placebo

PLACEBO COMPARATOR

maltodextrin, vegetable magnesium stearate

Dietary Supplement: Placebo

Interventions

Microalgae Extract Capsules DIETARY_SUPPLEMENT

Tetrasol extract

Microalgae extract capsules

Placebo DIETARY_SUPPLEMENT

maltodextrin \& vegetable magnesium stearate

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Colorado State University: lead
• Mycrophyt LLC: collaborator

Study Sites (1)

Food and Nutrition Clinical Research Lab(FNCRL), Colorado State University

Fort Collins, Colorado, 80526, United States

Location

Related Publications (4)

• 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.

  PMID: 11347287 BACKGROUND

• 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.

  PMID: 25192306 BACKGROUND

• 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.

  PMID: 28025954 BACKGROUND

• Maltz S, Nacey AT, Maury J, Ghanem N, Lee SY, Aquilino TM, Graham EL, Wrigley SD, Whittington JM, Khandaker AM, Hart RA, Byrne L, Wei Y, Pradelles R, Johnson SA, Weir TL. Effects of Supplementation with Microalgae Extract from Tetradesmus obliquus Strain Mi175.B1.a on Gastrointestinal Symptoms and Mental Health in Healthy Adults: A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Trial. Nutrients. 2025 Mar 10;17(6):960. doi: 10.3390/nu17060960.

  PMID: 40289936 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Tiffany L Weir, MSc,PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, parallel arm, double-blind, placebo-controlled diet intervention

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 22, 2024
• Study Start: February 5, 2024
• Primary Completion: May 24, 2024
• Study Completion: January 31, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)