Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome
Completed · Phase 1
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT02656056
- Run by
- Yale University
- People needed
- 22
- Starts
- 2016-01-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2018-05-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Yale University — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.