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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656056
• Other study ID #: 1507016139
• Status: Completed
• Phase: Phase 1
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: May 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Obesity

Intervention

Other:
• Food: (Q-Can Plus fermented soybean beverage)
Fermented soybean beverage. Dose is 8 oz, twice daily.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	BESO Biological Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	24-hour Dietary Recall	ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire	2 weeks prior to baseline (at baseline)
Other	24-hour Dietary Recall	ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire	baseline
Other	24-hour Dietary Recall	ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire	4 weeks
Other	24-hour Dietary Recall	ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire	12 weeks
Primary	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
Primary	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	Change in activation of the inflammasome machinery in peripheral blood cells with Pro-Il-1ß	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-1ß. Up-regulation of pro-cytokines will be performed by quantitative PCR.	baseline to week 12
Secondary	Change in activation of the inflammasome machinery in peripheral blood cells with Pro-TNF-a	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-a. Up-regulation of pro-cytokines will be performed by quantitative PCR.	baseline to week 12
Secondary	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
Secondary	Change in activation of the inflammasome machinery in peripheral blood cells with IL-1ß	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-1ß production. Detection of cytokines will be by conventional ELISA.	baseline to week 12
Secondary	Change in activation of the inflammasome machinery in peripheral blood cells with TNF-a	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-a production. Detection of cytokines will be by conventional ELISA.	baseline to week 12
Secondary	Change in activation of the inflammasome machinery in peripheral blood cells	Damage associated molecular patterns (DAMPs) will be assayed.	baseline to week 12