Food Ingredient for Stomachache

Overseen By Zoe Benham, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Koralo GmbH

Must not be taking: Gut medications, Mood medications

Disqualifiers: Gastrointestinal disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 who often have minor stomach discomfort. They must be willing to take a daily food ingredient mix, use a smartphone or computer, and fill out questionnaires in English.

Inclusion Criteria

I can give my consent electronically.

I have access to a smartphone or computer.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume the investigational food ingredient daily for 30 days, with assessments at baseline, Day 15, and Day 30

4 weeks

3 virtual assessments (Day 0, Day 15, Day 30)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

The study tests if a daily nutritional ingredient from fermented oyster mushroom mycelium and microalgae can improve gut well-being and mood over 30 days. Participants will report their experiences at the start, halfway, and end of the period.

How Is the Trial Designed?

Group I: Low Dose Experimental Treatment 1 Intervention

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.

Group II: High Dose Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Koralo GmbH

Lead Sponsor