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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in total mood disturbances
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participants, the research team interacting with the participants, and the primary data analyst will be blinded.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental
Participants will be consuming a blend of cordyceps, reishi, and lion's mane mushrooms .
干预措施: Mushroom blend (Dietary Supplement)
Control
Organic Acacia Gum will be the placebo product for this study.
干预措施: Placebo (Other)
结局指标
主要结局
Changes in total mood disturbances
时间窗: 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 symptoms rating scale.
时间窗: 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
时间窗: 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 the gastrointestinal microbiota alpha diversity
时间窗: 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
时间窗: 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.
时间窗: 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.
时间窗: 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).
次要结局
- Frequency of gastrointestinal distress.(Baseline and Day 42.)
研究者
Shawn M. Arent
Professor
University of South Carolina