Recruiting

Oyster Mushroom Mycelium, Microalgae & Bamboo Fibre

Sponsor:

Koralo GmbH

Code:

NCT07407777

Conditions

Gastrointestinal Discomfort

Digestive Well Being

Gut-related Symptoms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief 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

Conditions

Gastrointestinal Discomfort

Digestive Well Being

Gut-related Symptoms

Study ID

NCT07407777

Start date

Jan 19, 2026

Status verified date

Feb, 2026

Completion date

May 19, 2026

Anticipated

Primary completion date

May 19, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Low Dose

Participants assigned to this arm will consume 600 mg per day of the investigational food ingredient (active blend) derived from the co-fermentation of Pleurotus pulmonarius mycelium and Chlorella vulgaris microalgae. The powdered product will be taken once daily for 30 days by mixing it into a beverage of the participant's choice. Gastrointestinal symptoms and mood-related outcomes will be assessed at baseline, Day 15, and Day 30 using validated self-report questionnaires.

experimental: High Dose

Participants assigned to this arm will consume 4,000 mg per day of the investigational food ingredient (active blend) derived from the co-fermentation of Pleurotus pulmonarius mycelium and Chlorella vulgaris microalgae. The powdered product will be taken once daily for 30 days by mixing it into a beverage of the participant's choice. Gastrointestinal symptoms and mood-related outcomes will be assessed at baseline, Day 15, and Day 30 using validated self-report questionnaires.

Interventions

Food 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

Primary outcome measure

  • Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score [ Time Frame: Baseline (Day 0) to Day 30 ]

Central Contacts and Locations

Central contacts

Guido Albanese, PhD

+49 163 9144333guido@koralo-foods.com

Zoe Benham, B.S.

zoe@alethios.com

Locations

Alethios, Inc.

Recruiting

San Francisco, California, United States, 94109

Contacts

Zoe Benham, B.S.

9562771765zoe@alethios.com

Zeenia Framroze, M.A.

zeenia@alethios.com

More Information

Sponsor

Koralo GmbH

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • gut health
  • gastrointestinal symptoms
  • functional food ingredient
  • mood and well-being
  • dietary intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Koralo GmbH on 2026-02-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.