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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Food: (Q-Can Plus fermented soybean beverage)

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lean Adults; 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); Fermented soybean beverage. Dose is 8 oz, twice daily.
Experimental: Obese Adults; 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); Fermented soybean beverage. Dose is 8 oz, twice daily.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
24-hour Dietary Recall	ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire	baseline
24-hour Dietary Recall	ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire	4 weeks
24-hour Dietary Recall	ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire	12 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: BESO Biological Research, Inc.
• Investigators: Principal Investigator: Eugene Shapiro, MD, Yale University; Principal Investigator: Wajahat Mehal, MD, PhD, Yale University

Publications and helpful links

General Publications

• Dioletis E, Paiva RS, Kaffe E, Secor ER, Weiss TR, Fields MR, Ouyang X, Ali A. The fermented soy beverage Q-CAN(R) plus induces beneficial changes in the oral and intestinal microbiome. BMC Nutr. 2021 Mar 4;7(1):6. doi: 10.1186/s40795-021-00408-4.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: January 11, 2016
• First Posted (Estimate): January 14, 2016

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 1507016139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED