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OpenTrials
Completed

NCT Number: NCT02656056

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale University

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Food: (Q-Can Plus fermented soybean beverage)

Other

Fermented soybean beverage. Dose is 8 oz, twice daily.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • BESO Biological Research, Inc.

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 14, 2016
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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