Evaluation of Gut-Related Well-Being and Mood Effects of a Daily Nutritional Food Ingredient From… (NCT07407777) | Clinical Trial Compass
RecruitingNot Applicable
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)
United States80 participantsStarted 2026-01-19
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score