RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-05
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06425094

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  1. * BMI \>30.0 or \<18.0
  2. * Smoking or other use of tobacco products
  3. * Diagnosed intestinal diseases such as Celiac, Crohn's Disease, Ulcerative Colitis, or Gastrointestinal Cancers
  4. * Pregnant or breastfeeding individuals
  5. * Regular use of NSAIDs or MAO inhibitors
  6. * Clinically diagnosed mental health disorders (clinical depression, bipolar disorder, etc.)

Contacts and Locations

Study Contact

Tiffany L Weir, MSc,PhD
CONTACT
(970) 491-4631
tiffany.weir@colostate.edu
Sarah A Johnson, RDN,MS,PhD
CONTACT
(970) 491-3807
sarah.johnson@colostate.edu

Principal Investigator

Tiffany L Weir, MSc,PhD
PRINCIPAL_INVESTIGATOR
Colorado State University

Study Locations (Sites)

Food and Nutrition Clinical Research Lab(FNCRL), Colorado State University
Fort Collins, Colorado, 80526
United States

Collaborators and Investigators

Sponsor: Colorado State University

  • Tiffany L Weir, MSc,PhD, PRINCIPAL_INVESTIGATOR, Colorado State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-05
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2024-02-05
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Gastrointestinal Problem
  • Anxiety
  • Stress
  • Gastrointestinal Symptoms