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)

February 6, 2026 updated by: Koralo GmbH

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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-declared GRAS safety dossier. The study will enroll a total of 80 adult participants (aged 18-65) in the United States using a fully remote, decentralized design conducted through the Alethios digital research platform.

Participants who meet eligibility criteria will be randomly assigned in an unbalanced allocation to one of two fixed-dose intervention groups: a high-dose arm receiving 4,000 mg/day of the active blend (n=50) or a low-dose arm receiving 600 mg/day (n=30). All participants will consume the assigned product once daily for 30 days by mixing the powder into a beverage of their choice. No placebo group is included, as the primary objective is to explore dose-related effects rather than to compare against no treatment. The study involves no invasive procedures, clinical visits, laboratory testing, or biological sample collection, and participants may continue their usual diet and daily activities throughout the study period.

Study outcomes will be assessed using validated, self-reported questionnaires administered electronically at three time points: baseline (Day 0), mid-intervention (Day 15), and end of study (Day 30). The primary outcome is change in gastrointestinal symptom severity, measured by the Gastrointestinal Symptom Rating Scale (GSRS). Secondary outcomes include changes in mood and psychological well-being, assessed using the Profile of Mood States-2 Short Form (POMS-2-SF), as well as changes in GSRS subscale scores. Exploratory analyses will compare effect sizes between the two dose levels to assess potential dose-response relationships. Participant burden is minimal, with an estimated total time commitment of approximately 90 minutes over the entire study.

The study is classified as minimal risk, with anticipated risks limited to mild and transient gastrointestinal symptoms or rare allergic reactions consistent with the introduction of new dietary ingredients. Safety monitoring is conducted through daily self-report check-ins and adverse event reporting within the digital platform, with automated alerts to study staff as needed. Participants may withdraw at any time without penalty. Collectively, the study is designed to generate preliminary human evidence on the safety, tolerability, and potential benefits of the investigational food ingredient for gastrointestinal comfort and overall well-being in a mildly symptomatic, otherwise healthy adult population, providing a strong scientific rationale for future research.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Dietary supplement: 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
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.
Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score
Time Frame: Baseline (Day 0) to Day 30
The primary outcome is the change in gastrointestinal symptom severity as measured by the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a validated self-report questionnaire assessing the severity of common gastrointestinal symptoms. Change in total GSRS score will be evaluated over the course of the 30-day intervention to assess the effect of the investigational food ingredient on gut-related well-being.
Baseline (Day 0) to Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Profile of Mood States-2 Short Form (POMS-2-SF) Total Mood Disturbance Score
Time Frame: Baseline (Day 0) to Day 30
The secondary outcome is the change in mood and psychological well-being as measured by the Profile of Mood States-2 Short Form (POMS-2-SF). The POMS-2-SF is a validated self-report questionnaire assessing mood states across multiple domains. Change in total mood disturbance score will be evaluated to assess the effect of the investigational food ingredient on mood and overall well-being during the intervention period.
Baseline (Day 0) to Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koralo GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2026

Primary Completion (Estimated)

May 19, 2026

Study Completion (Estimated)

May 19, 2026

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KOR001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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