Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07407777

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)

Led by Koralo GmbH · Updated on 2026-02-12

80

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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)

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Generally healthy individuals
  • Experience minor, non-clinical gastrointestinal discomfort at least twice per week for 63 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Alethios, Inc.

San Francisco, California, United States, 94109

Actively Recruiting

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Research Team

G

Guido Albanese, PhD

CONTACT

Z

Zoe Benham, B.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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