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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
40
A mushroom blend that is targeted to improve gastrointestinal symptoms.
Placebo product.
University of South Carolina Sport Science Lab
Columbia, South Carolina, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Visit 2 (Day 0) and Visit 4 (Day 42)
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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.
Time frame: 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).
Time frame: Visit 2 (Day 0) and Visit 4 (Day 42)
Frequency of gastrointestinal distress.
To determine if the study product reduces the frequency of reported gastrointestinal symptoms.
Time frame: Baseline and Day 42.