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

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ClinicalTrials.gov Identifier: NCT02656056
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
BESO Biological Research, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Other: Food: (Q-Can Plus fermented soybean beverage) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome
Actual Study Start Date : January 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

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.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Change in activation of the inflammasome machinery in peripheral blood cells with Pro-Il-1β [ Time Frame: 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.

  2. Change in activation of the inflammasome machinery in peripheral blood cells with Pro-TNF-α [ Time Frame: 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.

  3. Change in activation of the inflammasome machinery in peripheral blood cells with caspase-1 cleavage [ Time Frame: 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.

  4. Change in activation of the inflammasome machinery in peripheral blood cells with IL-1β [ Time Frame: 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.

  5. Change in activation of the inflammasome machinery in peripheral blood cells with TNF-α [ Time Frame: 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.

  6. Change in activation of the inflammasome machinery in peripheral blood cells [ Time Frame: baseline to week 12 ]
    Damage associated molecular patterns (DAMPs) will be assayed.


Other Outcome Measures:
  1. 24-hour Dietary Recall [ Time Frame: 2 weeks prior to baseline (at baseline) ]
    ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire

  2. 24-hour Dietary Recall [ Time Frame: baseline ]
    ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire

  3. 24-hour Dietary Recall [ Time Frame: 4 weeks ]
    ASA24™ National Cancer Institute Automated Self-Administered 24-hour Dietary Recall (http://epi.grants.cancer.gov/asa24//) Questionnaire

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656056


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
BESO Biological Research, Inc.
Investigators
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Principal Investigator: Eugene Shapiro, MD Yale University
Principal Investigator: Wajahat Mehal, MD, PhD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02656056     History of Changes
Other Study ID Numbers: 1507016139
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes