Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Change in microbiome species proportion- Oral
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Lean Adults
Adults with a BMI between 21-25 will consume 8 oz of the fermented soybean beverage, twice daily.
Intervention: Food: (Q-Can Plus fermented soybean beverage) (Other)
Obese Adults
Adults with a BMI between 32-37 will consume 8 oz of the fermented soybean beverage, twice daily.
Intervention: Food: (Q-Can Plus fermented soybean beverage) (Other)
Outcomes
Primary Outcomes
Change in microbiome species proportion- Oral
Time Frame: baseline to week 12
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.
Change in microbiome species proportion- Intestinal
Time Frame: baseline to week 12
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.
Secondary Outcomes
- Change in activation of the inflammasome machinery in peripheral blood cells with IL-1β(baseline to week 12)
- Change in activation of the inflammasome machinery in peripheral blood cells(baseline to week 12)
- Change in activation of the inflammasome machinery in peripheral blood cells with TNF-α(baseline to week 12)
- Change in activation of the inflammasome machinery in peripheral blood cells with Pro-Il-1β(baseline to week 12)
- Change in activation of the inflammasome machinery in peripheral blood cells with Pro-TNF-α(baseline to week 12)
- Change in activation of the inflammasome machinery in peripheral blood cells with caspase-1 cleavage(baseline to week 12)