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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKoralo GmbH

About 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Diagnosed gastrointestinal disease (e.g., IBS, IBD, GERD requiring medication)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Low DoseExperimental treatment 1 intervention
Group B: High DoseExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
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

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.

Time frame
Baseline (Day 0) to Day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.