Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome

Study Overview
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Brief Summary
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The consumption of fermented soy foods can alter the human microbiome and may confer health benefits. Researchers propose a line of inquiry to assess the effects of Q-Can Plus (QC) fermented soy beverage in humans, assessing immunological, microbiological, and clinical parameters.

Detailed Description
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The study will start with a detailed testing of the microorganisms present in the QC fermented soy liquid, using deep sequencing. Subsequently, the researchers will determine the effect of the QC fermented soy product on the microbiome and inflammation in lean and obese individuals, as obese individuals are known to have dysbiosis. The work on inflammatory changes will be supplemented by studies to investigate the cellular and molecular mechanistic pathways responsible for the biological action of QC fermented soy liquid.

Official Title
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Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome

Conditions
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Obesity

Intervention / Treatment
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* Other: Food: (Q-Can Plus fermented soybean beverage)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (aged between 18 and 70) that are obese (BMI 32-37) (n=10) Adults (aged between 18 and 70) that are lean (BMI 21-25) (n=10) Exclusion Criteria: Allergy to soy or soy derivatives. Patients will be excluded if they had abdominal surgeries (excluding cholecystectomy, appendectomy, hysterectomy, and hernia repair). History of inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) and/or gastrointestinal bleeding. Medications: Antibiotics, probiotics, or systemic corticosteroids (within 6 months of enrollment). Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function. Patients will be excluded if using medications which are known to be affected by modest dietary changes. This will include, but is not limited to, warfarin and immunosuppressives such as cyclosporin. Alcohol use disorder, anorexia nervosa, autoimmune disease, bulimia, celiac disease, chronic infections, and illicit drug use. Major changes in dietary habits in past six months. Pregnancy or intent to get pregnant during study period Use of tobacco, including cigarettes, smokeless tobacco, cigars, and pipes within 30 days of enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lean Adults<br>Adults with a BMI between 21-25 will consume 8 oz of the fermented soybean beverage, twice daily. | Other: Food: (Q-Can Plus fermented soybean beverage)<br>* Fermented soybean beverage. Dose is 8 oz, twice daily.<br>|
| Experimental: Obese Adults<br>Adults with a BMI between 32-37 will consume 8 oz of the fermented soybean beverage, twice daily. | Other: Food: (Q-Can Plus fermented soybean beverage)<br>* Fermented soybean beverage. Dose is 8 oz, twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microbiome species proportion- Oral | Microbiome analysis will be conducted by calculating the significance in changes in the proportion of species between the groups, and by principal component analysis (PCA) to identify patterns of shift in the microbiome populations in relation to QC-induced changes. | baseline to week 12 | 
| Change in microbiome species proportion- Intestinal | Microbiome analysis will be conducted by calculating the significance in changes in the proportion of species between the groups, and by principal component analysis (PCA) to identify patterns of shift in the microbiome populations in relation to QC-induced changes. | baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activation of the inflammasome machinery in peripheral blood cells with Pro-Il-1β | This will be done by obtaining monocytes/macrophages from the peripheral blood and then activating them with LPS and ATP to induce up-regulation of Pro-Il-1β. Up-regulation of pro-cytokines will be performed by quantitative PCR. | baseline to week 12 | 
| Change in activation of the inflammasome machinery in peripheral blood cells with Pro-TNF-α | This will be done by obtaining monocytes/macrophages from the peripheral blood and then activating them with LPS and ATP to induce up-regulation of Pro-TNF-α. Up-regulation of pro-cytokines will be performed by quantitative PCR. | baseline to week 12 | 
| Change in activation of the inflammasome machinery in peripheral blood cells with caspase-1 cleavage | This will be done by obtaining monocytes/macrophages from the peripheral blood and then activating them with LPS and ATP to induce caspase-1 cleavage. | baseline to week 12 | 
| Change in activation of the inflammasome machinery in peripheral blood cells with IL-1β | This will be done by obtaining monocytes/macrophages from the peripheral blood and then activating them with LPS and ATP to induce up-regulation of IL-1β production. Detection of cytokines will be by conventional ELISA. | baseline to week 12 | 
| Change in activation of the inflammasome machinery in peripheral blood cells with TNF-α | This will be done by obtaining monocytes/macrophages from the peripheral blood and then activating them with LPS and ATP to induce up-regulation of TNF-α production. Detection of cytokines will be by conventional ELISA. | baseline to week 12 | 
| Change in activation of the inflammasome machinery in peripheral blood cells | Damage associated molecular patterns (DAMPs) will be assayed. | baseline to week 12 |