Daily mushroom and microalgae powder for gut comfort and mood
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
NA · Koralo GmbH · NCT07407777
This 30-day remote study will test whether a daily powdered blend made from oyster mushroom mycelium, microalgae, and bamboo fiber improves gut comfort and mood in generally healthy adults with mild gastrointestinal discomfort.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Koralo GmbH (industry) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07407777 on ClinicalTrials.gov |
What this trial studies
This is a 30-day, two-arm, open-label dietary intervention enrolling 80 adults aged 18–65 who report minor, non-clinical gastrointestinal discomfort. Participants are randomized in an unbalanced allocation to a high-dose arm (4,000 mg/day, n=50) or a low-dose arm (600 mg/day, n=30) and consume the powdered product once daily mixed into a beverage. Outcomes include the Gastrointestinal Symptom Rating Scale (GSRS) and the Profile of Mood States 2 Short Form (POMS-2-SF) measured at baseline, day 15, and day 30, with no invasive procedures or biological sampling. The product is a cGMP-manufactured, food-grade blend from co-fermented Pleurotus pulmonarius mycelium and Chlorella vulgaris microalgae with bamboo fiber and flavoring, deployed via a fully remote platform.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults (18–65) who experience minor gastrointestinal discomfort at least twice weekly for three months or more, can consume a daily powdered beverage, and have access to a smartphone or computer for remote participation.
Not a fit: People with diagnosed gastrointestinal diseases (for example IBS, IBD, or GERD requiring medication), those on recent medications affecting gut function or mood, pregnant or breastfeeding individuals, or those with major chronic conditions are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this could offer a convenient dietary option to reduce minor gut discomfort and modestly improve mood for people with mild symptoms.
How similar studies have performed: This exact co-fermented mushroom–microalgae blend is novel with limited direct clinical data, although separate small studies of mushroom extracts or microalgae supplements have suggested modest gut or mood effects.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: * 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
Where this trial is running
San Francisco, California
- Alethios, Inc. — San Francisco, California, United States (RECRUITING)
Study contacts
- Study coordinator: Guido Albanese, PhD
- Email: guido@koralo-foods.com
- Phone: +49 163 9144333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastrointestinal Discomfort, Digestive Well Being, Gut-related Symptoms, gut health, gastrointestinal symptoms, functional food ingredient, mood and well-being, dietary intervention