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
Koralo GmbH
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
Description
This study is a 30-day, two-arm, open-label dietary intervention designed to evaluate the effects of a daily nutritional food ingredient on gastrointestinal well-being and mood in generally healthy adults experiencing minor, non-clinical gastrointestinal discomfort. The investigational product is a powdered food ingredient derived from the co-fermentation of fungal mycelium (Pleurotus pulmonarius) and microalgae (Chlorella vulgaris), blended with bamboo fiber and flavoring components for palatability. The product is food-grade, manufactured under cGMP conditions, and supported by a self-declar…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 medicatio…
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
Location
- Alethios, Inc.San Francisco, California