80 Participants Needed

Food Ingredient for Stomachache

GA
ZB
Overseen ByZoe Benham, B.S.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a food ingredient made from mushrooms, microalgae, and bamboo to determine its effects on minor stomach issues and mood in healthy adults. Participants will take either a low or high dose of the ingredient daily for 30 days. The trial aims to assess how the ingredient influences gut health and mood over time. Individuals who have experienced minor stomach discomfort twice a week for the past three months and can complete online surveys in English may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research on natural ingredients and their potential health benefits.

Will I have to stop taking my current medications?

If you're taking medications that affect your gut or mood, you would need to stop them at least 30 days before joining the study. The trial doesn't allow new gut, immune, or mood supplements started within 15 days before the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the food ingredient made from oyster mushroom roots (mycelium) and microalgae is generally safe to eat. Studies have found that the roots of the oyster mushroom contain fewer harmful substances than the mushroom itself, which is already safe to consume. This suggests the roots are likely safe too.

Although some people may have allergies to mushrooms, this does not specifically apply to the roots used in this treatment. Overall, strong evidence of serious side effects from this food ingredient is lacking. Participants in past studies did not report major problems, indicating that most people tolerate this treatment well.12345

Why are researchers excited about this trial?

Unlike typical treatments for stomachaches, which often include over-the-counter medications like antacids and proton pump inhibitors, this investigational treatment uses a unique blend of oyster mushroom mycelium and microalgae. This natural combination is thought to provide not only digestive relief but also mood benefits, thanks to its rich nutrient profile and potential anti-inflammatory properties. The treatment stands out because it's taken as a simple, daily drink mix, offering a more natural and holistic approach to managing stomach discomfort. Researchers are excited about this because it could offer a dual benefit for both gut health and emotional well-being, which is a novel approach compared to conventional treatments.

What evidence suggests that this food ingredient could be effective for minor gastrointestinal discomfort?

Research has shown that a food ingredient made from oyster mushrooms and microalgae might help with minor stomach issues. Studies have found that diets including mushrooms can support a healthy gut by encouraging the growth of beneficial bacteria. In this trial, participants will receive either a low or high dose of the investigational food ingredient derived from oyster mushrooms and microalgae, both known for their gut health benefits. Early results suggest that these ingredients might reduce discomfort and improve mood by acting as prebiotics, which help good bacteria grow in the gut.12367

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.
See 5 more

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?

2

Treatment groups

Experimental Treatment

Group I: Low DoseExperimental Treatment1 Intervention
Group II: High DoseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Koralo GmbH

Lead Sponsor

Citations

Evaluation of Gut-Related Well-Being and Mood Effects ...

The purpose of the study is to evaluate the gut-related well-being and mood effects experiencing minor gastrointestinal discomfort

Evaluation of Gut-Related Well-Being and Mood Effects of a ...

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 ...

Food Ingredient for Stomachache

The study tests if a daily nutritional ingredient from fermented oyster mushroom mycelium and microalgae can improve gut well-being and mood ...

Modulation of the Gut Microbiota with Prebiotics and ... - PMC

A mushroom-based diet can support a healthy gut microbiome and reduce the need for antibiotics. Keywords: prebiotics, probiotics, Pleurotus ...

Advancing Solid-State Fermentation with Culinary Fungi for ...

Solid-state fermentation with culinary fungi (mushrooms could be a scalable means of producing nutrient-dense protein foods, while improving ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39429921/

Edibility and safety of mycelium of the oyster mushroom ...

These were found to be lower in the mycelium compared to fruiting bodies, which are already considered safe for consumption. Instead, a number ...

Product: Mycelium from oyster mushroom - Food Safety

Pleurotus ostreatus is known to be antigenic and can cause adverse effects after inhalation or after skin contact. Genotoxic potential of the novel food was ...