Status:
COMPLETED
The Effect of Concord Grape Polyphenol-soy Protein Isolate Complex (GP-SPI) on Gut Microbiota
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Mechanisms, Defense
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
The overall purpose of this study is to evaluate the effect of nutritional supplementation with a well-characterized preparation of Concord grape polyphenol-soy protein isolate (GP-SPI) on the composi...
Detailed Description
The proposed study will investigate how short-term supplementation with GP-SPI may modify the gut microbial community in healthy participants while monitoring liver and kidney function/health. Signif...
Eligibility Criteria
Inclusion
- Healthy as assessed based on a medical evaluation including a comprehensive metabolic panel (CMP) test with values in normal range, medical history and not presently taking any medication
- Adults between 18 and 35 years
- BMI 18.5 -29.9
- Have at least one bowel movement per day
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion
- History/current cancer, rheumatoid arthritis immunologic, renal, hepatic, endocrine, neurologic or heart disease, hypertension, diabetes, GI dysfunction, or CMP test results showing values outside of normal range.
- Cannot provide written informed consent.
- Exposure to any experimental agent or procedure within 30 days of study.
- Pregnancy or breast-feeding
- Taking dietary supplements
- Current smoker or have smoked within previous 6 months
- Taking medications regularly (prescription, over the counter, supplements etc.)
- Treated with antibiotics during the past 6 months
- Have an allergy to soy or grapes
Key Trial Info
Start Date :
June 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04018066
Start Date
June 28 2019
End Date
December 20 2019
Last Update
December 23 2025
Active Locations (1)
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1
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, United States, 08901