Effects of a Mushroom Blend on Gastrointestinal Symptoms and the Microbiome

NCT07027462 | Completed

• 1 other identifier: Pro00144162
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Gastrointestinal Discomfort; Mood; Mushroom

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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).

  Visit 2 (Day 0) and Visit 4 (Day 42)

Secondary Outcomes (1)

• Frequency of gastrointestinal distress.

  Baseline and Day 42.

Study Arms (2)

Experimental

EXPERIMENTAL

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

Dietary Supplement: Mushroom blend

Control

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Mushroom blend DIETARY_SUPPLEMENT

A mushroom blend that is targeted to improve gastrointestinal symptoms.

Experimental

Placebo OTHER

Placebo product.

Control

Eligibility Criteria

• Age: 30 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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 \[i.e., Ri-Mucil, Metamucil (psyllium), Colace, Milk of Magnesia, MiraLAX, FiberCon (polycarophil), DulcoLax, etc.\]

Sponsors & Collaborators

• University of South Carolina: lead
• M2 Ingredients: collaborator
• Substantiation Sciences, LLC: collaborator

Study Sites (1)

University of South Carolina Sport Science Lab

Columbia, South Carolina, 29208, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, the research team interacting with the participants, and the primary data analyst will be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Between-subjects, placebo-controlled study design.

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 18, 2025
• Study Start: June 16, 2025
• Primary Completion: December 30, 2025
• Study Completion: March 2, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)