The Effect of Concord Grape Polyphenol-soy Protein Isolate Complex (GP-SPI) on Gut Microbiota

Completed · Not applicable

Conditions studied: Mechanisms, Defense

In brief

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.

Key facts

Study ID: NCT04018066
Run by: Rutgers, The State University of New Jersey
People needed: 34
Starts: 2019-06-28
Expected to finish: 2019-12-20
Last updated by the study team: 2026-06-18

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Rutgers, The State University of New Jersey — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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