Trial Outcomes & Findings for The Effect of Concord Grape Polyphenol-soy Protein Isolate Complex (GP-SPI) on Gut Microbiota (NCT NCT04018066)
NCT ID: NCT04018066
Last Updated: 2025-12-23
Results Overview
Evaluate the effect of nutritional supplementation with GP-SPI on gut microbiota composition by 16S rRNA amplicon sequencing and analysis
COMPLETED
NA
34 participants
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.
2025-12-23
Participant Flow
34 participants were enrolled in the study based on inclusion/exclusion criteria. 4 participants withdrawn from the study, due to the following reasons: 3 started taking medications and 1 had scheduling conflicts. Of the remaining 30 participants that completed the study, 3 were excluded due to protocol deviations.
Participant milestones
| Measure |
GP-SPI Intervention
Each participant consumed 20 g of soy protein isolate (SPI) twice per day for 5 days. After a one day break, participants then consumed 20 g of GP-SPI taken twice per day for 10 days. During the entire 17 day study period, participants abstained from an extensive list of PAC-rich foods.
GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)
|
|---|---|
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Overall Study
STARTED
|
34
|
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Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
GP-SPI Intervention
Each participant consumed 20 g of soy protein isolate (SPI) twice per day for 5 days. After a one day break, participants then consumed 20 g of GP-SPI taken twice per day for 10 days. During the entire 17 day study period, participants abstained from an extensive list of PAC-rich foods.
GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)
|
|---|---|
|
Overall Study
participants started taking medications during the study period
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3
|
|
Overall Study
participant dropped out due to schedule conflicts.
|
1
|
Baseline Characteristics
The Effect of Concord Grape Polyphenol-soy Protein Isolate Complex (GP-SPI) on Gut Microbiota
Baseline characteristics by cohort
| Measure |
GP-SPI Intervention
n=27 Participants
Each participant consumed 20 g of soy protein isolate (SPI) twice per day for 5 days. After a one day break, participants then consumed 20 g of GP-SPI taken twice per day for 10 days. During the entire 17 day study period, participants abstained from an extensive list of PAC-rich foods.
GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)
|
|---|---|
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Age, Customized
Age
|
21.7 years
STANDARD_DEVIATION 3.5 • n=68 Participants
|
|
Sex: Female, Male
Female
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16 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=68 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=68 Participants
|
|
Glucose
|
88.78 mg/dL
STANDARD_DEVIATION 6.25 • n=68 Participants
|
|
Blood urea nitrogen
|
12.81 mg/dL
STANDARD_DEVIATION 4.3 • n=68 Participants
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|
Creatine
|
0.76 mg/dL
STANDARD_DEVIATION 0.19 • n=68 Participants
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|
Calcium
|
9.82 mg/dL
STANDARD_DEVIATION 0.38 • n=68 Participants
|
|
Sodium
|
142.7 mmol/L
STANDARD_DEVIATION 2.28 • n=68 Participants
|
|
Potassium
|
4.83 mmol/L
STANDARD_DEVIATION 0.34 • n=68 Participants
|
|
Chloride
|
103.4 mmol/L
STANDARD_DEVIATION 2.8 • n=68 Participants
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|
Total carbon dioxide
|
26.04 mmol/L
STANDARD_DEVIATION 1.72 • n=68 Participants
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|
Anion gap
|
13.26 meq/L
STANDARD_DEVIATION 2.19 • n=68 Participants
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Protein
|
7.38 g/dL
STANDARD_DEVIATION 0.37 • n=68 Participants
|
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Albumin
|
4.83 g/dL
STANDARD_DEVIATION 0.34 • n=68 Participants
|
|
Bilirubin total
|
0.54 mg/dL
STANDARD_DEVIATION 0.26 • n=68 Participants
|
|
Alkaline phosphatase
|
68.56 IU/L
STANDARD_DEVIATION 15.19 • n=68 Participants
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|
Alkaline transaminase
|
21.26 IU/L
STANDARD_DEVIATION 5.4 • n=68 Participants
|
|
Alanine transaminase
|
16.89 IU/L
STANDARD_DEVIATION 7.44 • n=68 Participants
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PRIMARY outcome
Timeframe: 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.Population: All 27 participant samples were analyzed.
Evaluate the effect of nutritional supplementation with GP-SPI on gut microbiota composition by 16S rRNA amplicon sequencing and analysis
Outcome measures
| Measure |
GP-SPI Intervention
n=27 Participants
Each participant consumed 20 g of soy protein isolate (SPI) twice per day for 5 days. After a one day break, participants then consumed 20 g of GP-SPI taken twice per day for 10 days. During the entire 17 day study period, participants abstained from an extensive list of PAC-rich foods.
GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)
|
|---|---|
|
Gut Microbiota Composition
Actinobacteria (day 10), % relative abundance
|
8.1 percentage of bacterial phyla
Standard Deviation 5.6
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Gut Microbiota Composition
Proteobacteria (day 10), % relative abundance
|
4.1 percentage of bacterial phyla
Standard Deviation 2.6
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|
Gut Microbiota Composition
Tenericutes (day 10), % relative abundance
|
0.03 percentage of bacterial phyla
Standard Deviation 0.1
|
|
Gut Microbiota Composition
Bacteroidetes (day -5), % relative abundance
|
30 percentage of bacterial phyla
Standard Deviation 9.7
|
|
Gut Microbiota Composition
Verrucomicrobia (day -5), % relative abundance
|
0.04 percentage of bacterial phyla
Standard Deviation 0.1
|
|
Gut Microbiota Composition
Verrucomicrobia (day 10), % relative abundance
|
0.07 percentage of bacterial phyla
Standard Deviation 0.13
|
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Gut Microbiota Composition
Actinobacteria (day -5), % relative abundance
|
7.3 percentage of bacterial phyla
Standard Deviation 5.3
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Gut Microbiota Composition
Proteobacteria (day -5), % relative abundance
|
4 percentage of bacterial phyla
Standard Deviation 2.9
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Gut Microbiota Composition
Tenericutes (day -5), % relative abundance
|
0.4 percentage of bacterial phyla
Standard Deviation 0.1
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Gut Microbiota Composition
Firmicutes (day 0), % relative abundance
|
59.3 percentage of bacterial phyla
Standard Deviation 6.9
|
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Gut Microbiota Composition
Bacteroidetes (day 0), % relative abundance
|
31.1 percentage of bacterial phyla
Standard Deviation 8.06
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Gut Microbiota Composition
Verrucomicrobia (day 0), % relative abundance
|
0.04 percentage of bacterial phyla
Standard Deviation 0.09
|
|
Gut Microbiota Composition
Actinobacteria (day 0), % relative abundance
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5.29 percentage of bacterial phyla
Standard Deviation 3.7
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Gut Microbiota Composition
Proteobacteria (day 0), % relative abundance
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3.66 percentage of bacterial phyla
Standard Deviation 2.66
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|
Gut Microbiota Composition
Tenericutes (day 0), % relative abundance
|
0.009 percentage of bacterial phyla
Standard Deviation 0.05
|
|
Gut Microbiota Composition
Firmicutes (day 10), % relative abundance
|
54.3 percentage of bacterial phyla
Standard Deviation 8.9
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Gut Microbiota Composition
Bacteroidetes (day 10), % relative abundance
|
33.44 percentage of bacterial phyla
Standard Deviation 10.4
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Gut Microbiota Composition
Firmicutes (day -5), % relative abundance
|
58 percentage of bacterial phyla
Standard Deviation 10
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SECONDARY outcome
Timeframe: Samples will be analyzed within one week of blood collectionPopulation: CMP data was measured for all 27 participants
Evaluate the effect of GP-SPI on kidney and liver health/function via CMP blood tests ALP, AST, ALT
Outcome measures
| Measure |
GP-SPI Intervention
n=27 Participants
Each participant consumed 20 g of soy protein isolate (SPI) twice per day for 5 days. After a one day break, participants then consumed 20 g of GP-SPI taken twice per day for 10 days. During the entire 17 day study period, participants abstained from an extensive list of PAC-rich foods.
GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)
|
|---|---|
|
Comprehensive Metabolic Panel (CMP) Blood Test (ALP, AST, ALT)
Alkaline phosphatase
|
70.7 IU/L
Standard Deviation 16.79
|
|
Comprehensive Metabolic Panel (CMP) Blood Test (ALP, AST, ALT)
Aspartate transaminase (IU/L)
|
21.41 IU/L
Standard Deviation 5.6
|
|
Comprehensive Metabolic Panel (CMP) Blood Test (ALP, AST, ALT)
Alkaline transaminase
|
17.52 IU/L
Standard Deviation 8.59
|
SECONDARY outcome
Timeframe: Samples will be analyzed within one week of blood collectionPopulation: CMP data was measured for all 27 participants
Evaluate the effect of GP-SPI on kidney and liver health/function via CMP blood tests Measure glucose, blood urea nitrogen, creatine, calcium, bilirubin total
Outcome measures
| Measure |
GP-SPI Intervention
n=27 Participants
Each participant consumed 20 g of soy protein isolate (SPI) twice per day for 5 days. After a one day break, participants then consumed 20 g of GP-SPI taken twice per day for 10 days. During the entire 17 day study period, participants abstained from an extensive list of PAC-rich foods.
GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)
|
|---|---|
|
Comprehensive Metabolic Panel (CMP) Blood Test (Glucose, Blood Urea Nitrogen, Creatine, Calcium, Bilirubin Total)
Glucose
|
85.96 mg/dL
Standard Deviation 6.79
|
|
Comprehensive Metabolic Panel (CMP) Blood Test (Glucose, Blood Urea Nitrogen, Creatine, Calcium, Bilirubin Total)
Blood urea nitrogen
|
14.81 mg/dL
Standard Deviation 3.28
|
|
Comprehensive Metabolic Panel (CMP) Blood Test (Glucose, Blood Urea Nitrogen, Creatine, Calcium, Bilirubin Total)
Creatine
|
0.76 mg/dL
Standard Deviation 0.18
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|
Comprehensive Metabolic Panel (CMP) Blood Test (Glucose, Blood Urea Nitrogen, Creatine, Calcium, Bilirubin Total)
Calcium
|
9.64 mg/dL
Standard Deviation 0.53
|
|
Comprehensive Metabolic Panel (CMP) Blood Test (Glucose, Blood Urea Nitrogen, Creatine, Calcium, Bilirubin Total)
Bilirubin total
|
0.54 mg/dL
Standard Deviation 0.25
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SECONDARY outcome
Timeframe: Samples will be analyzed within one week of blood collectionPopulation: CMP data was measured for all 27 participants
The Anion gap was measured for all 27 participants. The anion gap is a calculation of the difference between the amounts of some negatively charged electrolytes (such as chloride and bicarbonate) and the amount of positively charged electrolytes (such as sodium) in blood. The anion gap reveals whether blood has an imbalance of electrolytes, i.e., blood is too acidic or too basic.
Outcome measures
| Measure |
GP-SPI Intervention
n=27 Participants
Each participant consumed 20 g of soy protein isolate (SPI) twice per day for 5 days. After a one day break, participants then consumed 20 g of GP-SPI taken twice per day for 10 days. During the entire 17 day study period, participants abstained from an extensive list of PAC-rich foods.
GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)
|
|---|---|
|
Comprehensive Metabolic Panel Blood Test (Anion Gap)
|
14.41 meq/L
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Samples will be analyzed within one week of blood collectionPopulation: CMP data was measured for all 27 participants
For all 27 participants CMP measured four electrolytes: sodium, potassium, chloride, total carbon dioxide. Electrolytes are minerals that carry an electric charge when they are dissolved in a liquid. These electrolytes in blood control nerve and muscle function and maintain the acid-base balance (pH balance) of blood and water balance. Sodium: Most sodium comes from food, and kidneys help regulate body's sodium levels. Potassium: Potassium comes from food and is present in all tissues of body. Bicarbonate: Bicarbonate indicates the amount of carbon dioxide (CO₂) in blood. Chloride: Chloride functions along with sodium, potassium and bicarbonate to control many processes in the body.
Outcome measures
| Measure |
GP-SPI Intervention
n=27 Participants
Each participant consumed 20 g of soy protein isolate (SPI) twice per day for 5 days. After a one day break, participants then consumed 20 g of GP-SPI taken twice per day for 10 days. During the entire 17 day study period, participants abstained from an extensive list of PAC-rich foods.
GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)
|
|---|---|
|
Comprehensive Metabolic Panel (CMP) Blood Test (Sodium, Potassium, Chloride, Total Carbon Dioxide)
Sodium
|
142.2 mmol/L
Standard Deviation 2.33
|
|
Comprehensive Metabolic Panel (CMP) Blood Test (Sodium, Potassium, Chloride, Total Carbon Dioxide)
Potassium
|
4.57 mmol/L
Standard Deviation 0.43
|
|
Comprehensive Metabolic Panel (CMP) Blood Test (Sodium, Potassium, Chloride, Total Carbon Dioxide)
Chloride
|
102.3 mmol/L
Standard Deviation 1.7
|
|
Comprehensive Metabolic Panel (CMP) Blood Test (Sodium, Potassium, Chloride, Total Carbon Dioxide)
Total carbon dioxide
|
25.51 mmol/L
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: Samples will be analyzed within one week of blood collectionPopulation: CMP data was measured for all 27 participants
Evaluate the effect of GP-SPI on kidney and liver health/function via CMP blood tests
Outcome measures
| Measure |
GP-SPI Intervention
n=27 Participants
Each participant consumed 20 g of soy protein isolate (SPI) twice per day for 5 days. After a one day break, participants then consumed 20 g of GP-SPI taken twice per day for 10 days. During the entire 17 day study period, participants abstained from an extensive list of PAC-rich foods.
GP-SPI: grape polyphenol-soy protein isolate complex (GP-SPI)
|
|---|---|
|
Comprehensive Metabolic Panel (CMP) Blood Test (Protein, Albumin)
Protein
|
7.37 g/dL
Standard Deviation 0.33
|
|
Comprehensive Metabolic Panel (CMP) Blood Test (Protein, Albumin)
Albumin
|
4.87 g/dL
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: De-identified samples will be processed and analyzed after all subjects complete the study and within 1 year.Collect fecal, blood, and urine samples for a microbiome-wide association study (MWAS)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 applicationEnter de-identified study results into microbiome and metabolome nationwide data sharing database
Outcome measures
Outcome data not reported
Adverse Events
GP-SPI Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Diana Roopchand, Study Investigator
Rutgers, The State University of New Jersey
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place