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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Food: (Q-Can Plus fermented soybean beverage)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lean Adults

Obese Adults

Arm Description

Adults with a BMI between 21-25 will consume 8 oz of the fermented soybean beverage, twice daily.

Adults with a BMI between 32-37 will consume 8 oz of the fermented soybean beverage, twice daily.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Change in activation of the inflammasome machinery in peripheral blood cells
Damage associated molecular patterns (DAMPs) will be assayed.

Full Information

First Posted
January 6, 2016
Last Updated
May 9, 2018
Sponsor
Yale University
Collaborators
BESO Biological Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02656056
Brief Title
Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome
Official Title
Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
BESO Biological Research, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lean Adults
Arm Type
Experimental
Arm Description
Adults with a BMI between 21-25 will consume 8 oz of the fermented soybean beverage, twice daily.
Arm Title
Obese Adults
Arm Type
Experimental
Arm Description
Adults with a BMI between 32-37 will consume 8 oz of the fermented soybean beverage, twice daily.
Intervention Type
Other
Intervention Name(s)
Food: (Q-Can Plus fermented soybean beverage)
Intervention Description
Fermented soybean beverage. Dose is 8 oz, twice daily.
Primary Outcome Measure Information:
Title
Change in microbiome species proportion- Oral
Description
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.
Time Frame
baseline to week 12
Title
Change in microbiome species proportion- Intestinal
Description
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.
Time Frame
baseline to week 12
Secondary Outcome Measure Information:
Title
Change in activation of the inflammasome machinery in peripheral blood cells with Pro-Il-1β
Description
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.
Time Frame
baseline to week 12
Title
Change in activation of the inflammasome machinery in peripheral blood cells with Pro-TNF-α
Description
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.
Time Frame
baseline to week 12
Title
Change in activation of the inflammasome machinery in peripheral blood cells with caspase-1 cleavage
Description
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.
Time Frame
baseline to week 12
Title
Change in activation of the inflammasome machinery in peripheral blood cells with IL-1β
Description
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.
Time Frame
baseline to week 12
Title
Change in activation of the inflammasome machinery in peripheral blood cells with TNF-α
Description
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.
Time Frame
baseline to week 12
Title
Change in activation of the inflammasome machinery in peripheral blood cells
Description
Damage associated molecular patterns (DAMPs) will be assayed.
Time Frame
baseline to week 12
Other Pre-specified Outcome Measures:
Title
24-hour Dietary Recall
Description
ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire
Time Frame
2 weeks prior to baseline (at baseline)
Title
24-hour Dietary Recall
Description
ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire
Time Frame
baseline
Title
24-hour Dietary Recall
Description
ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire
Time Frame
4 weeks
Title
24-hour Dietary Recall
Description
ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Shapiro, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wajahat Mehal, MD, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33658080
Citation
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.
Results Reference
derived

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

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