Clinical trial NCT07027462: Effects of a Mushroom Blend on Gastrointestinal Symptoms and the Microbiome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Gastrointestinal Discomfort
Mood
Mushroom
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: M2 Ingredients
name: Substantiation Sciences, LLC
First posted: 2025-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between-subjects, placebo-controlled study design.
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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)
* 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.

Exclusion Criteria:

* 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
  * 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.

Primary outcomes:
measure: Changes in the gastrointestinal symptoms rating scale.
timeFrame: Visit 2 (Day 0), Visit 3 (Day 19-21), Visit 4 (Day 42)
measure: Changes in Assessment of Constipation - Quality of Life
timeFrame: Visit 2 (Day 0), Visit 3 (Day 19-21), Visit 4 (Day 42)
measure: Changes in total mood disturbances
timeFrame: Visit 2 (Day 0), Visit 3 (Day 19-21), Visit 4 (Day 42)
measure: Changes in the gastrointestinal microbiota alpha diversity
timeFrame: Visit 2 (Day 0) and Visit 4 (Day 42)
measure: Changes in the gastrointestinal microbiota beta diversity
timeFrame: Visit 2 (Day 0) and Visit 4 (Day 42)
measure: Changes in the gastrointestinal microbiota relative abundance of specific gut bacteria based on amplicon sequence variants.
timeFrame: Visit 2 (Day 0) and Visit 4 (Day 42)
measure: Changes in water-soluble polar metabolites.
timeFrame: Visit 2 (Day 0) and Visit 4 (Day 42)
Secondary outcomes:
measure: Frequency of gastrointestinal distress.
timeFrame: Baseline and Day 42.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina Sport Science Lab
state: South Carolina
Study officials:
References: