N/A
N=34
The Effect of Concord Grape Polyphenol-soy Protein Isolate Complex (GP-SPI) on Gut Microbiota
Mechanisms, Defense
Bottom Line
View on ClinicalTrials.gov: NCT04018066 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Gut Microbiota Composition — 58; 30; 0.04; 7.3 percentage of bacterial phyla
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GP-SPI (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gut Microbiota Composition |
58; 30; 0.04; 7.3; 4; 0.4 | — |
| SECONDARY Comprehensive Metabolic Panel (CMP) Blood Test (ALP, AST, ALT) |
70.7; 21.41; 17.52 | — |
| SECONDARY Comprehensive Metabolic Panel (CMP) Blood Test (Glucose, Blood Urea Nitrogen, Creatine, Calcium, Bilirubin Total) |
85.96; 14.81; 0.76; 9.64; 0.54 | — |
| SECONDARY Comprehensive Metabolic Panel Blood Test (Anion Gap) |
14.41 | — |
| SECONDARY Comprehensive Metabolic Panel (CMP) Blood Test (Sodium, Potassium, Chloride, Total Carbon Dioxide) |
142.2; 4.57; 102.3; 25.51 | — |
| SECONDARY Comprehensive Metabolic Panel (CMP) Blood Test (Protein, Albumin) |
7.37; 4.87 | — |
| SECONDARY Microbiome-wide Association Study |
— | — |
| SECONDARY Data Sharing |
— | — |
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
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04018066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.