RecruitingNot ApplicableNCT07407777

Evaluation of Gut-Related Well-Being and Mood Effects of a Daily Nutritional Food Ingredient From the Co-Fermentation of Fungal Mycelium (Pleurotus Pulmonarius) and Microalgae (Chlorella Vulgaris)

Evaluation of Gut-Related Well-Being and Mood Effects of a Daily Nutritional Food Ingredient From the Co-Fermentation of Fungal Mycelium (Pleurotus Pulmonarius) and Microalgae (Chlorella Vulgaris) in Healthy Adults Experiencing Minor Gastrointestinal Discomfort: A 30-Day, Two-Arm, Open-Label Study


Sponsor

Koralo GmbH

Enrollment

80 participants

Start Date

Jan 19, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to evaluate the gut-related well-being and mood effects of a food ingredient obtained from the co-fermentation of oyster mushroom mycelium (Pleurotus pulmonarius), microalgae (Chlorella vulgaris), and bamboo fibre in healthy adults (aged 18+) experiencing minor gastrointestinal discomfort during an intervention period of 30 days. The participants will be allocated into two unbalanced groups to determine relationships between the measurable outcomes and the dose levels at three different time points: start of the study (baseline), 15 days (middle), and 30 days (end-point), during which participants will be asked to complete GSRS and POMS-2-SF questionnaire


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • Adults aged 18 years or older
  • Generally healthy individuals
  • Experience minor, non-clinical gastrointestinal discomfort at least twice per week for ≥3 months
  • Willing to consume the study product once daily for 30 days
  • Able to dissolve and consume the powdered product in a beverage
  • Able to read, understand, and complete electronic questionnaires in English
  • Access to a smartphone or computer for study participation
  • Provide electronic informed consent

Exclusion Criteria8

  • Diagnosed gastrointestinal disease (e.g., IBS, IBD, GERD requiring medication)
  • Use of medications affecting gastrointestinal function or mood within the past 30 days
  • Initiation of new gut-, immune-, or mood-related supplements within 15 days prior to study start
  • Known allergy or sensitivity to study product components
  • Pregnancy or breastfeeding
  • Major chronic medical condition that could interfere with study participation or data interpretation
  • Participation in another interventional clinical study within the past 30 days
  • Inability or unwillingness to comply with study procedures

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTFood ingredient of oyster mushroom mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris)

Food ingredient obtained from the co-fermentation of oyster mushroom mycelium (Pleurotus pulmonarius), microalgae (Chlorella vulgaris) and added bamboo fibre with flavours for better palatability


Locations(1)

Alethios, Inc.

San Francisco, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07407777


Related Trials