HealthyNCT07027462
Effects of a Mushroom Blend on Gastrointestinal Symptoms and the Microbiome
A study testing Mushroom blend in people with Healthy, run by University of South Carolina at 1 site in United States.
Trial summary
This study will investigate the efficacy of a mushroom blend to improve gastrointestinal symptoms and mood. It will also be determining if the mushroom blend has an effect on the gut microbiome and metabolomics. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mushroom blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2025to 2 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females aged 30 to 60 years of age (inclusive).
- Subject has provided written and dated informed consent.
- Individual indicates they experience occasional GI discomfort, and have never been diagnosed with any gastrointestinal disorder, yet have occasional complaints of bowel irregularity, bloating or discomfort (after meals or beverages).
- Subject may express that they experience occasional after-snack or a meal, intestinal gas-related symptoms including abdominal discomfort, cramps, distended feeling/bloating, and or flatulence as part of the study entry criteria.
- Occasional GI distress will be defined as < 3 times per week over the prior 6 weeks, with each episode resolving within 24 hours and not requiring medical intervention.
- Body Mass Index (BMI) 19 to 34.9 kg/m2 (normal weight to class I obesity)
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- Subject is a non-smoker.
- Subject agrees to not use any new vitamin, mineral, or other dietary supplement product until after study completion.
- Subject agrees to provide a stool sample for microbiota analysis per the study protocol.
- Subject is willing and able to comply with the protocol and the scheduled study visits.
- Subject will be asked about dietary supplementation use within the past 6 months.
- If subject began taking a supplement within the past month, participant will be asked to discontinue supplement use followed by a 2-week washout prior to participation.
- In all other cases, supplement use will be asked to be maintained throughout the study.
Who cannot join
- Subject has any of the following medical conditions:
- Gastrointestinal disease or any GI diagnosed disorder (i.e., dyspepsia, functional dyspepsia, gastrointestinal reflux, etc.)
- active heart disease
- uncontrolled high blood pressure (≥ 140/90 mmHg)
- renal or hepatic impairment/disease
- Type I or II diabetes
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- bipolar disorder
- Parkinson's disease
- unstable thyroid disease
- immune disorder (such as HIV/AIDS)
- Any medical condition deemed exclusionary by the Principal Investigator (PI)
- Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
- Subject is currently taking any blood thinners.
- Subject has a medical condition that is known to impact the gastrointestinal system and functions.
- Subject is currently taking or has within the prior 120 days any prescription antibiotics, or supplemental probiotic or prebiotics (30-day washout is acceptable).
- Subject is currently taking supplemental (OTC medicine or dietary supplements) of any laxative or bowel function stimulant [i.e., Ri-Mucil, Metamucil (psyllium), Colace, Milk of Magnesia, MiraLAX, FiberCon (polycarophil), DulcoLax, etc.]
- Subject is on an unstable dose of medication (defined as fewer than 90 days at the same dose).
- Subject is taking a prescription medication deemed exclusionary by the Principal Investigator (PI).
- Subject has an allergy to any ingredients in the Study Product.
- Subject has a history of drug or alcohol abuse in the past 12 months.
- Subject has a history of a psychiatric illness or mental health disorder (including for drug or alcohol treatment) that required hospitalization in the prior 12 months.
- Subject has any condition or health history abnormality that in the expert opinion of the PI, participation in the study would compromise the safety of the subject or the quality of the study data.
- The subject is participating in or has participated in another clinical research study within 30 days prior to the Screening visit.
- Subject is consuming any of the study products already.
- Subject is diagnosed with a stress-disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina Sport Science Lab
Columbia, South Carolina, 29208
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Clinical Trial Of A Mushroom Blend To Evaluate Its Impacts On Gastrointestinal and Overall Quality Of Life and Microbiome Makeup In Healthy Adults
This study will investigate the efficacy of a mushroom blend to improve gastrointestinal symptoms and mood. It will also be determining if the mushroom blend has an effect on the gut microbiome and metabolomics.
- Conditions
- Healthy
- Being tested
- Mushroom blend, Placebo
- Keywords
- Gastrointestinal Discomfort, Mood, Mushroom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mushroom blendDietary supplement
A mushroom blend that is targeted to improve gastrointestinal symptoms.
PlaceboOther
Placebo product.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will be consuming a blend of cordyceps, reishi, and lion's mane mushrooms . Receives: Dietary Supplement: Mushroom blend |
| Control | Placebo comparator | Organic Acacia Gum will be the placebo product for this study. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the gastrointestinal symptoms rating scale.
To determine if the study product has any effect on digestion. Scores range from 0 - 45, with higher scores indicating severe gastrointestinal issues.
Measured: Visit 2 (Day 0), Visit 3 (Day 19-21), Visit 4 (Day 42)
Changes in Assessment of Constipation - Quality of Life
To determine if the study product has any effect on quality of life in individuals suffering from constipation. It is scored as means of each item, ranging from 0 - 4 with higher scores indicating worse quality of life.
Measured: Visit 2 (Day 0), Visit 3 (Day 19-21), Visit 4 (Day 42)
Changes in total mood disturbances
To determine if the study product has any effect on mood states. The total mood is calculated by adding the negative subscales (tension, depression, fatigue, confusion, and anger) subtracting the positive subscales (vigor, esteem-related affect). Higher scores indicate worse moods.
Measured: Visit 2 (Day 0), Visit 3 (Day 19-21), Visit 4 (Day 42)
Changes in the gastrointestinal microbiota alpha diversity
To determine if the study product has any effect on the gut microbiota composition.
6S rRNA gene (V4 amplicon) sequencing will be performed to profile the gut microbial community of frozen fecal samples collected from all humans to ascertain how the Mushroom Blend impacts gut microbial community structure of alpha diversity.
Measured: Visit 2 (Day 0) and Visit 4 (Day 42)
Changes in the gastrointestinal microbiota beta diversity
To determine if the study product has any effect on the gut microbiota composition.
6S rRNA gene (V4 amplicon) sequencing will be performed to profile the gut microbial community of frozen fecal samples collected from all humans to ascertain how the Mushroom Blend impacts gut microbial community structure of beta diversity.
Measured: Visit 2 (Day 0) and Visit 4 (Day 42)
Changes in the gastrointestinal microbiota relative abundance of specific gut bacteria based on amplicon sequence variants.
To determine if the study product leads to an increase or decrease in the gastrointestinal microbiota relative abundance of specific gut bacteria. 6S rRNA gene (V4 amplicon) sequencing will be performed to profile the gut microbial community of frozen fecal samples collected from all humans to ascertain how the Mushroom Blend impacts gut microbial relative abundance of specific gut bacteria based on amplicon sequence variants.
Measured: Visit 2 (Day 0) and Visit 4 (Day 42)
Changes in water-soluble polar metabolites.
To determine if the study product leads to an increase or decrease in water-soluble polar metabolites. positive and negative metabolites will be extracted from serum using a protocol optimized for water soluble polar metabolite analysis using Liquid Chromatography coupled with Mass Spectrometry (LC-MS).
Measured: Visit 2 (Day 0) and Visit 4 (Day 42)
Secondary outcomes (1)
Frequency of gastrointestinal distress.
To determine if the study product reduces the frequency of reported gastrointestinal symptoms.
Measured: Baseline and Day 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start16 Jun 2025
- Primary completion30 Dec 2025
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Between-subjects, placebo-controlled study design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- M2 Ingredients, Substantiation Sciences, LLC
- Responsible party
- Principal investigator, Shawn M. Arent, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027462
- Sponsor's protocol ID
- Pro00144162
- Status last verified
- Mar 2026
- First submitted
- 2 Jun 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Clinical Trial Of A Mushroom Blend To Evaluate Its Impacts On Gastrointestinal and Overall Quality Of Life and Microbiome Makeup In Healthy Adults
- ClinicalTrials.gov ID
- NCT07027462
- Acronym / sponsor ID
- Pro00144162
- Conditions
- Healthy
- Keywords
- Gastrointestinal Discomfort, Mood, Mushroom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- M2 Ingredients, Substantiation Sciences, LLC
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the efficacy of a mushroom blend to improve gastrointestinal symptoms and mood. It will also be determining if the mushroom blend has an effect on the gut microbiome and metabolomics.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Between-subjects, placebo-controlled study design.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Mushroom blendParticipants will be consuming a blend of cordyceps, reishi, and lion's mane mushrooms . |
| Control | Placebo comparator | Other: PlaceboOrganic Acacia Gum will be the placebo product for this study. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy males and females aged 30 to 60 years of age (inclusive).
- Subject has provided written and dated informed consent.
- Individual indicates they experience occasional GI discomfort, and have never been diagnosed with any gastrointestinal disorder, yet have occasional complaints of bowel irregularity, bloating or discomfort (after meals or beverages).
- Subject may express that they experience occasional after-snack or a meal, intestinal gas-related symptoms including abdominal discomfort, cramps, distended feeling/bloating, and or flatulence as part of the study entry criteria.
- Occasional GI distress will be defined as < 3 times per week over the prior 6 weeks, with each episode resolving within 24 hours and not requiring medical intervention.
Key exclusion criteria (25 listed)
- Subject has any of the following medical conditions:
- Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
- Subject is currently taking any blood thinners.
- Subject has a medical condition that is known to impact the gastrointestinal system and functions.
- Subject is currently taking or has within the prior 120 days any prescription antibiotics, or supplemental probiotic or prebiotics (30-day washout is acceptable).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mushroom blendA mushroom blend that is targeted to improve gastrointestinal symptoms. | Dietary supplement | Experimental |
| PlaceboPlacebo product. | Other | Control |
Primary outcome
Changes in the gastrointestinal symptoms rating scale.
Time frame: Visit 2 (Day 0), Visit 3 (Day 19-21), Visit 4 (Day 42)
To determine if the study product has any effect on digestion. Scores range from 0 - 45, with higher scores indicating severe gastrointestinal issues.
Changes in Assessment of Constipation - Quality of Life
Time frame: Visit 2 (Day 0), Visit 3 (Day 19-21), Visit 4 (Day 42)
To determine if the study product has any effect on quality of life in individuals suffering from constipation. It is scored as means of each item, ranging from 0 - 4 with higher scores indicating worse quality of life.
Changes in total mood disturbances
Time frame: Visit 2 (Day 0), Visit 3 (Day 19-21), Visit 4 (Day 42)
To determine if the study product has any effect on mood states. The total mood is calculated by adding the negative subscales (tension, depression, fatigue, confusion, and anger) subtracting the positive subscales (vigor, esteem-related affect). Higher scores indicate worse moods.
Changes in the gastrointestinal microbiota alpha diversity
Time frame: Visit 2 (Day 0) and Visit 4 (Day 42)
To determine if the study product has any effect on the gut microbiota composition. 6S rRNA gene (V4 amplicon) sequencing will be performed to profile the gut microbial community of frozen fecal samples collected from all humans to ascertain how the Mushroom Blend impacts gut microbial community structure of alpha diversity.
Changes in the gastrointestinal microbiota beta diversity
Time frame: Visit 2 (Day 0) and Visit 4 (Day 42)
To determine if the study product has any effect on the gut microbiota composition. 6S rRNA gene (V4 amplicon) sequencing will be performed to profile the gut microbial community of frozen fecal samples collected from all humans to ascertain how the Mushroom Blend impacts gut microbial community structure of beta diversity.
Changes in the gastrointestinal microbiota relative abundance of specific gut bacteria based on amplicon sequence variants.
Time frame: Visit 2 (Day 0) and Visit 4 (Day 42)
To determine if the study product leads to an increase or decrease in the gastrointestinal microbiota relative abundance of specific gut bacteria. 6S rRNA gene (V4 amplicon) sequencing will be performed to profile the gut microbial community of frozen fecal samples collected from all humans to ascertain how the Mushroom Blend impacts gut microbial relative abundance of specific gut bacteria based on amplicon sequence variants.
Changes in water-soluble polar metabolites.
Time frame: Visit 2 (Day 0) and Visit 4 (Day 42)
To determine if the study product leads to an increase or decrease in water-soluble polar metabolites. positive and negative metabolites will be extracted from serum using a protocol optimized for water soluble polar metabolite analysis using Liquid Chromatography coupled with Mass Spectrometry (LC-MS).
1 secondary outcome
Frequency of gastrointestinal distress.
Time frame: Baseline and Day 42.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mushroom blend in people with Healthy, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the gastrointestinal symptoms rating scale. (time frame: Visit 2 (Day 0), Visit 3 (Day 19-21), Visit 4 (Day 42)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.