The Effect of Concord Grape Polyphenol-soy Protein Isolate Complex (GP-SPI) on Gut Microbiota
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Gut Microbiota Composition
Study Overview
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 composition of the gut microbiota.
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.
Significance:
Biochemical properties of the GP-SPI food ingredient are well-documented and GP-SPI and SPI supplements have been tested extensively in mice. The proposed study is a logical follow up to animal studies, which showed that compared to control mice fed a high-fat diet (HFD) supplemented with SPI alone, mice fed an isocaloric HFD supplemented with GP-SPI exhibited greater resistance to weight gain, adiposity, and glucose intolerance. These effects were accompanied by changes in murine gut microbiota composition, including increased abundance of the microbe Akkermansia muciniphila, associated with metabolic resilience. Similar gut microbiota changes were observed in lean mice fed low-fat diet (LFD) supplemented with GP-SPI.
The B-type proanthocyanidin (PAC) class of polyphenols contained in grape berries, especially skins and seeds, have been associated with health benefits; however, PACs are poorly absorbed and reach high concentration only in the colon raising questions about mechanism(s) of action. Prior studies showed that dietary PACs from grape and cranberry alter the gut microbiota in association with metabolic resilience. PACs are also biotransformed by gut bacteria to yield microbial metabolites (MMs) that may contribute to health benefits.
Research Design and Methods
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
GP-SPI intervention
20 g of GP-SPI taken twice per day for 10 days
Intervention: GP-SPI (Dietary Supplement)
Outcomes
Primary Outcomes
Gut Microbiota Composition
Time Frame: 16S rRNA amplicon sequencing will be performed on samples collected at baseline (before intervention, day -5), after 5 days of SPI supplementation (day 0), and after 10 days of GP-SPI supplementation (day 10). Total time frame is 17 days.
Evaluate the effect of nutritional supplementation with GP-SPI on gut microbiota composition by 16S rRNA amplicon sequencing and analysis
Secondary Outcomes
- Comprehensive Metabolic Panel (CMP) Blood Test (ALP, AST, ALT)(Samples will be analyzed within one week of blood collection)
- Comprehensive Metabolic Panel (CMP) Blood Test (Glucose, Blood Urea Nitrogen, Creatine, Calcium, Bilirubin Total)(Samples will be analyzed within one week of blood collection)
- Comprehensive Metabolic Panel Blood Test (Anion Gap)(Samples will be analyzed within one week of blood collection)
- Comprehensive Metabolic Panel (CMP) Blood Test (Sodium, Potassium, Chloride, Total Carbon Dioxide)(Samples will be analyzed within one week of blood collection)
- Comprehensive Metabolic Panel (CMP) Blood Test (Protein, Albumin)(Samples will be analyzed within one week of blood collection)
- Microbiome-wide Association Study(De-identified samples will be processed and analyzed after all subjects complete the study and within 1 year.)
- Data Sharing(Data will be deposited no later than within 1 year of the completion of the funded project period for the parent award or upon acceptance of the data for publication, or public disclosure of a submitted patent application)
Investigators
Diana Roopchand, Ph.D.
Associate Professor
Rutgers, The State University of New Jersey