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

Phase 1

Completed

• Conditions: Obesity

• Registration Number: NCT02656056
• Lead Sponsor: Yale University

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-14
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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)

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in microbiome species proportion- Oral	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	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 Outcome Measures

Name	Time	Method
Change in activation of the inflammasome machinery in peripheral blood cells with TNF-α	baseline to week 12	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.
Change in activation of the inflammasome machinery in peripheral blood cells	baseline to week 12	Damage associated molecular patterns (DAMPs) will be assayed.
Change in activation of the inflammasome machinery in peripheral blood cells with Pro-Il-1β	baseline to week 12	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.
Change in activation of the inflammasome machinery in peripheral blood cells with Pro-TNF-α	baseline to week 12	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.
Change in activation of the inflammasome machinery in peripheral blood cells with caspase-1 cleavage	baseline to week 12	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.
Change in activation of the inflammasome machinery in peripheral blood cells with IL-1β	baseline to week 12	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.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States