RECRUITING

Effects of a Mushroom Blend on Gastrointestinal Symptoms and the Microbiome

Conditions

Healthy Gastrointestinal Discomfort Mood Mushroom

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-06-16

Study Completion:2026-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07027462

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Gianna F Mastrofini, MS

CONTACT

7034246509

giannafm@email.sc.edu

Shawn M Arent, PhD

CONTACT

803-576-8394

sarent@mailbox.sc.edu

Study Locations (Sites)

University of South Carolina Sport Science Lab

Columbia, South Carolina, 29208

United States

Collaborators and Investigators

Sponsor: University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-16

Study Completion Date2026-01-30

Study Record Updates

Study Start Date2025-06-16

Study Completion Date2026-01-30

Terms related to this study

Keywords Provided by Researchers

Gastrointestinal Discomfort
Mood
Mushroom

Additional Relevant MeSH Terms

Healthy