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Completed
NCT04018066
The Effect of Concord Grape Polyphenol-soy Protein Isolate Complex (GP-SPI) on Gut Microbiota
Conditions: Mechanisms, Defense
Sex: All
Ages: 18 Years – 35 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 34
Sponsor: Rutgers, The State University of New Jersey
Location: Rutgers, The State University of New Jersey New Brunswick New Jersey
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 composition of the gut microbiota.
Eligibility Criteria
Inclusion Criteria:
1. 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
2. Adults between 18 and 35 years
3. BMI 18.5 -29.9
4. Have at least one bowel movement per day
5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
1. 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.
2. Cannot provide written informed consent.
3. Exposure to any experimental agent or procedure within 30 days of study.
4. Pregnancy or breast-feeding
5. Taking dietary supplements
6. Current smoker or have smoked within previous 6 months
7. Taking medications regularly (prescription, over the counter, supplements etc.)
8. Treated with antibiotics during the past 6 months
9. Have an allergy to soy or grapes
Source: ClinicalTrials.gov (NCT04018066). StuddyBuddy aggregates publicly available trial information.