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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Lean Adults

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

Group Type EXPERIMENTAL

Food: (Q-Can Plus fermented soybean beverage)

Intervention Type OTHER

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

Obese Adults

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

Group Type EXPERIMENTAL

Food: (Q-Can Plus fermented soybean beverage)

Intervention Type OTHER

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

Interventions

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Food: (Q-Can Plus fermented soybean beverage)

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes