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)

NCT07407777 | Recruiting

• 1 other identifier: KOR001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score

  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 Outcomes (1)

• Change in Profile of Mood States-2 Short Form (POMS-2-SF) Total Mood Disturbance Score

  Baseline (Day 0) to Day 30

Study Arms (2)

Low Dose

EXPERIMENTAL

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)

High Dose

EXPERIMENTAL

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)

Interventions

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

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

High Dose; Low Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koralo GmbH: lead

Study Sites (1)

Alethios, Inc.

San Francisco, California, 94109, United States

RECRUITING

Central Study Contacts

Guido Albanese, PhD

CONTACT

+49 163 9144333; guido@koralo-foods.com

Zoe Benham, B.S.

CONTACT

zoe@alethios.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. This is an open-label study in which participants and study staff are aware of dose assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomized into two parallel intervention arms receiving different fixed daily doses of the investigational food ingredient (high-dose and low-dose) over a 30-day period. There is no placebo or crossover; outcomes are assessed longitudinally at baseline, Day 15, and Day 30

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): May 19, 2026
• Study Completion (Estimated): May 19, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)