Mushroom Blend for Gut Health

Overseen By Shawn M Arent, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Must not be taking: Blood thinners, Antibiotics, Laxatives

Disqualifiers: GI disease, Heart disease, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a blend of mushrooms can improve gut health and mood. Researchers are examining how these mushrooms might affect gut symptoms and the bacteria in the gut. Participants will take either a mushroom blend containing cordyceps, reishi, and lion's mane or a placebo made of organic acacia gum. The trial seeks healthy individuals aged 30 to 60 who experience mild gut discomfort, such as bloating or gas, but do not have any diagnosed gastrointestinal disorders. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on natural remedies for gut health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not be on blood thinners, certain bowel supplements, or antibiotics. If you started a new supplement in the past month, you'll need to stop it and wait two weeks before joining.

Is there any evidence suggesting that the mushroom blend is likely to be safe for humans?

Research has shown that the mushroom blend, which includes cordyceps, reishi, and lion's mane mushrooms, is generally safe for most people. Specifically, lion's mane mushroom is likely safe at a dose of 1 gram daily for up to 16 weeks, with most individuals experiencing only mild side effects like stomach discomfort. Although specific safety studies for lion's mane are lacking, it is widely considered safe with minimal side effects.

Reishi mushrooms may aid sleep, reduce stress, and boost immunity. However, specific safety information for reishi or cordyceps is not available. The trial's advanced stage suggests some confidence in the safety of this mushroom blend. Always consult a healthcare provider before trying new treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for gut health, which often rely on probiotics or dietary changes, the mushroom blend being studied is unique because it harnesses the natural benefits of cordyceps, reishi, and lion's mane mushrooms. These mushrooms are believed to have powerful anti-inflammatory and immune-boosting properties, potentially offering a new way to support gut health by improving the gut microbiome and reducing inflammation. Researchers are excited about this treatment because it could provide a holistic, natural alternative to existing options, potentially with fewer side effects and added health benefits.

What evidence suggests that this mushroom blend is effective for gut health?

Research has shown that a blend of mushrooms, including cordyceps, reishi, and lion's mane, may support gut health. In this trial, participants in the experimental arm will consume this mushroom blend. Studies have found that these mushrooms can boost the production of substances beneficial for gut bacteria, potentially improving digestion and overall gut function. Lion's mane has also shown promise in protecting the stomach lining and reducing ulcers in animal studies. Additionally, reishi and lion's mane have been used to enhance food healthiness, indicating possible health benefits. While mushrooms are generally safe, some people might experience mild digestive issues. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy individuals interested in seeing if a mushroom blend can improve their gastrointestinal health and mood. Specific eligibility criteria are not provided, but typically participants should meet certain health standards to be considered 'healthy subjects'.

Inclusion Criteria

Subject has provided written and dated informed consent

I am between 30 and 60 years old.

Subject agrees to not use any new vitamin, mineral, or other dietary supplement product until after study completion

Exclusion Criteria

I have had cancer other than non-spreading skin cancer in the last 5 years.

I have not taken antibiotics or probiotics in the last 30 days.

I am not on any medication that the study leader would exclude.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a mushroom blend or placebo to evaluate its impact on gastrointestinal symptoms and microbiome

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mushroom Blend

Trial Overview The study is testing the effects of a special mushroom blend versus a placebo on gastrointestinal symptoms, mood, and changes in gut microbiome composition. Participants will randomly receive either the mushroom blend or an inactive substance.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Participants will be consuming a blend of cordyceps, reishi, and lion's mane mushrooms .

Group II: Control Placebo Group 1 Intervention

Organic Acacia Gum will be the placebo product for this study.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Substantiation Sciences, LLC

Collaborator

M2 Ingredients

Industry Sponsor

Trials

1

Recruited

150+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1756464625002543

Prebiotic activity of functional whole mushroom powders in ... All tested mushroom powders stimulated short-chain fatty acid production. All powders enhanced bacterial populations known to be beneficial to human health.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7826851/

Medicinal Mushrooms: Bioactive Compounds, Use, and ... Consumption of the mushroom proved safe in almost all patients. Only in nine cases were adverse events recorded, mainly digestive, such as nausea and diarrhea.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06870136

Study Evaluating the Quality and Effects of Lion's Mane ... The study will evaluate cognitive health outcomes in a broad age-range of adults who have chosen to try this product. The study will incorporate memory and ...

4. mdpi.com mdpi.com/2076-3921/12/3/738

The Addition of Reishi and Lion's Mane Mushroom Powder ... The results suggest that Reishi and Lion's Mane mushroom powder can be used for the fortification of semolina pasta, conferring slightly healthier ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3835629/

Gastroprotective Effects of Lion's Mane Mushroom ... The rats treated with mushroom extract at 200 mg/kg demonstrated comparatively better protection of the gastric mucosa as reduction or absence of ulcer area, ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK599740/

Lion's Mane - LiverTox - NCBI Bookshelf - NIH Lion's mane has not been subjected to prospective trials of its safety but is widely described as being well tolerated and without side effects.

7. webmd.com webmd.com/vitamins/ai/ingredientmono-1536/lions-mane-mushroom

Lion'S Mane Mushroom - Uses, Side Effects, and More Lion's mane mushroom is possibly safe when used in a dose of 1 gram daily for 16 weeks. Side effects are mild and may include stomach discomfort.

8. amazon.com amazon.com/Four-Sigmatic-Mushroom-Blend-Dual-Extract/dp/B07CF55GLC

Four Sigmatic Gut Health Mushroom Blend | Organic ... Reishi mushrooms, or Ganoderma lucidum, may help to support the body's sleep cycles, help the body adapt to stress, and boost immunity.

9. vinmec.com vinmec.com/eng/blog/9-health-benefits-of-lions-mane-mushroom-and-side-effects-en

9 Health Benefits of Lion's Mane Mushrooms and Side Effects Lion's mane extract may protect against the development of stomach ulcers by inhibiting the growth of H. pylori and protecting the stomach ...