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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

Tracking Information
First Submitted Date  ICMJE January 6, 2016
First Posted Date  ICMJE January 14, 2016
Last Update Posted Date May 10, 2018
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02656056 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 15, 2016)
  • 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
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome
Official Title  ICMJE Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Obesity
Intervention  ICMJE Other: Food: (Q-Can Plus fermented soybean beverage)
Fermented soybean beverage. Dose is 8 oz, twice daily.
Study Arms  ICMJE
  • Experimental: Lean Adults
    Adults with a BMI between 21-25 will consume 8 oz of the fermented soybean beverage, twice daily.
    Intervention: Other: Food: (Q-Can Plus fermented soybean beverage)
  • Experimental: Obese Adults
    Adults with a BMI between 32-37 will consume 8 oz of the fermented soybean beverage, twice daily.
    Intervention: Other: Food: (Q-Can Plus fermented soybean beverage)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2017)
22
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2016)
20
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02656056
Other Study ID Numbers  ICMJE 1507016139
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE BESO Biological Research, Inc.
Investigators  ICMJE
Principal Investigator: Eugene Shapiro, MD Yale University
Principal Investigator: Wajahat Mehal, MD, PhD Yale University
PRS Account Yale University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP