Clinical trial NCT02656056: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: BESO Biological Research, Inc.
First posted: 2016-01-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in microbiome species proportion- Oral
timeFrame: baseline to week 12
measure: Change in microbiome species proportion- Intestinal
timeFrame: baseline to week 12
Secondary outcomes:
measure: Change in activation of the inflammasome machinery in peripheral blood cells with Pro-Il-1β
timeFrame: baseline to week 12
measure: Change in activation of the inflammasome machinery in peripheral blood cells with Pro-TNF-α
timeFrame: baseline to week 12
measure: Change in activation of the inflammasome machinery in peripheral blood cells with caspase-1 cleavage
timeFrame: baseline to week 12
measure: Change in activation of the inflammasome machinery in peripheral blood cells with IL-1β
timeFrame: baseline to week 12
measure: Change in activation of the inflammasome machinery in peripheral blood cells with TNF-α
timeFrame: baseline to week 12
measure: Change in activation of the inflammasome machinery in peripheral blood cells
timeFrame: baseline to week 12
Other outcomes:
measure: 24-hour Dietary Recall
timeFrame: 2 weeks prior to baseline (at baseline)
measure: 24-hour Dietary Recall
timeFrame: baseline
measure: 24-hour Dietary Recall
timeFrame: 4 weeks
measure: 24-hour Dietary Recall
timeFrame: 12 weeks
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Eugene Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Wajahat Mehal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.