Trial Outcomes & Findings for Cimarrón Bean Extrudate Solution on Platelet Function and Biochemical Parameters (NCT NCT07043829)
NCT ID: NCT07043829
Last Updated: 2026-04-09
Results Overview
The platelet reactivity was assessed in response to three agonists: ADP, CRP, and TRAP-6. The expression changes of P-selectin and the binding of Fibrinogen to the platelet were measured at baseline (0 hours) and 6 hours. The data were analyzed using dose-response curves and derived metrics of these curves, including basal activity (minimum), maximal response (maximum), EC50, and Capacity of response as the difference between the maximal response and the basal state.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline (0 hours) and 6 hours post-intervention
Results posted on
2026-04-09
Participant Flow
Participants were recruited from 14-10-2024 to 13-03-2025 through posters, flyers, and announcements in university of Talca facilities. Interested individuals received an information sheet, completed an initial digital survey, and had their questions addressed. Written informed consent was obtained, and copies were provided to participants.
Participants were screened for eligibility through medical history review and fasting blood glucose measurement. Eligible participants provided written informed consent before enrollment
Participant milestones
| Measure |
SPVCE Intervention
Participants will receive a single oral dose of 10 grams of SPVCE. Platelet function (Reactivity and blood risk), postprandial glycemia and Polyphenol concentration will be measured before and after the intervention.
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SPVCE Intervention
n=30 Participants
Participants will receive a single oral dose of 10 grams of SPVCE. Platelet reactivity and postprandial glycemia will be measured before and after the intervention.
SPVCE (Solution Phaseolus vulgaris L. var. Cimarrón Extrudate in Water): A single oral dose of 10 grams of Cimarrón bean (Phaseolus vulgaris L., variety Cimarrón) extrudate dissolved in 500 mL of water, consumed once under fasting conditions, to evaluate acute effects on platelet function, postprandial glycemia, and total polyphenol concentration after SPVCE consumption.
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Age, Continuous
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29.9 years
STANDARD_DEVIATION 10.45 • n=30 Participants
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Sex: Female, Male
Female
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18 Participants
n=30 Participants
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Sex: Female, Male
Male
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12 Participants
n=30 Participants
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Height
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1.63 meters
STANDARD_DEVIATION 0.077 • n=30 Participants
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Weight
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70 kilograms
STANDARD_DEVIATION 13.5 • n=30 Participants
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Body Mass Index (BMI)
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26.28 Kg/m^2
STANDARD_DEVIATION 3.4 • n=30 Participants
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PRIMARY outcome
Timeframe: Baseline (0 hours) and 6 hours post-interventionThe platelet reactivity was assessed in response to three agonists: ADP, CRP, and TRAP-6. The expression changes of P-selectin and the binding of Fibrinogen to the platelet were measured at baseline (0 hours) and 6 hours. The data were analyzed using dose-response curves and derived metrics of these curves, including basal activity (minimum), maximal response (maximum), EC50, and Capacity of response as the difference between the maximal response and the basal state.
Outcome measures
| Measure |
SPVCE Intervention
n=30 Participants
Participants will receive a single oral dose of 10 grams of SPVCE. Platelet reactivity postprandial glycemia, polyphenols levels in plasma and PFA-200 Time closure were measured before (baseline) and after the intervention (2 hours and 6 hours).
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Sensibility Fibrinogen- ADP EC50 Baseline (0 hours)
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0.23 μM
Standard Deviation 0.13
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Sensibility Fibrinogen- ADP EC50 6 hours
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0.16 μM
Standard Deviation 0.11
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Sensibility Fibrinogen- CRP EC50 Baseline (0 hours)
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0.05 μM
Standard Deviation 0.02
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Sensibility Fibrinogen- CRP EC50 6 hours
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0.05 μM
Standard Deviation 0.03
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Sensibility Fibrinogen-TRAP-6 EC50 Baseline (0 hours)
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1.96 μM
Standard Deviation 0.72
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Sensibility Fibrinogen-TRAP-6 EC50 6 hours
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1.47 μM
Standard Deviation 0.46
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Sensibility P-selectin- ADP EC50 Baseline (0 hours)
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0.60 μM
Standard Deviation 0.19
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Sensibility P-selectin- ADP EC50 6 hours
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0.52 μM
Standard Deviation 0.16
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Sensibility P-selectin- CRP EC50 Baseline (0 hours)
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0.05 μM
Standard Deviation 0.03
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Sensibility P-selectin- CRP EC50 6 hours
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0.05 μM
Standard Deviation 0.03
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Sensibility P-selectin-TRAP-6 EC50 Baseline (0 hours)
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3.09 μM
Standard Deviation 1.18
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Sensibility P-selectin-TRAP-6 EC50 6 hours
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2.5 μM
Standard Deviation 0.59
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Capacity Fibrinogen-ADP baseline (0 hours)
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887.2 μM
Standard Deviation 133.0
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Capacity Fibrinogen-ADP 6 hours
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918.4 μM
Standard Deviation 114.5
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Capacity Fibrinogen- CRP baseline (0 hours)
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845.1 μM
Standard Deviation 248.5
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Capacity Fibrinogen-CRP 6 hours
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828.8 μM
Standard Deviation 243.9
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Capacity Fibrinogen-TRAP-6 Baseline (0 hours)
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1233 μM
Standard Deviation 233.1
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Capacity Fibrinogen-TRAP-6 6 hours
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1251 μM
Standard Deviation 193.0
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Capacity P-selectin-ADP baseline (0 hours)
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1177 μM
Standard Deviation 279.3
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Capacity P-selectin ADP 6 hours
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1092 μM
Standard Deviation 289.8
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Capacity P-selectin-CRP baseline (0 hours)
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2711 μM
Standard Deviation 726.5
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Capacity P-selectin CRP 6 hours
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2628 μM
Standard Deviation 602.5
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Capacity P-selectin-TRAP-6 baseline (0 hours)
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3378 μM
Standard Deviation 746.4
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Capacity P-selectin-TRAP-6 6 hours
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3450 μM
Standard Deviation 711.5
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Basal Activity (Minimun) Fibrinogen-ADP Baseline (0 hours)
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1145 μM
Standard Deviation 254.9
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Basal Activity (Minimum) Fibrinogen-ADP 6 hours
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1011 μM
Standard Deviation 188.7
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Basal Activity Fibrinogen-CRP Baseline (0 hours)
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1043 μM
Standard Deviation 217.1
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Basal activity Fibrinogen-CRP 6 hours
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968.2 μM
Standard Deviation 122.5
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Basal Activity Fibrinogen-TRAP-6 Baseline (0 hours)
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1069 μM
Standard Deviation 228.9
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Basal Activity Fibrinogen-TRAP-6 6 hours
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986.1 μM
Standard Deviation 162.1
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Basal Activity P-selectin-ADP Baseline (0 hours)
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471.3 μM
Standard Deviation 132.7
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Basal Activity P-selectin-ADP 6 hours
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319.5 μM
Standard Deviation 127.8
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Basal Activity P-selectin-CRP Baseline (0 hour)
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516.5 μM
Standard Deviation 138.3
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Basal Activity P-selectin-CRP 6 hours
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354.5 μM
Standard Deviation 167.0
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Basal Activity P-selectin-TRAP-6 Baseline (0 hours)
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482.5 μM
Standard Deviation 140.9
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Basal Actitivy P-selectin-TRAP-6 6 hours
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313.5 μM
Standard Deviation 117.8
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Maximal Response Fibrinogen-ADP Baseline (0 hours)
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1764 μM
Standard Deviation 280.6
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Maximal Response Fibrinogen-ADP 6 hours
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1555 μM
Standard Deviation 242.5
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Maximal Response Fibrinogen-CRP Baseline (0 hours)
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1730 μM
Standard Deviation 424.2
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Maximal Response Fibrinogen-CRP 6 hours
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1500 μM
Standard Deviation 338.8
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Maximal Response Fibrinogen-TRAP-6 Baseline (0 hours)
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2098 μM
Standard Deviation 394.0
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Maximal Response Fibrinogen-TRAP-6 6 hours
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1934 μM
Standard Deviation 285.4
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Maximal Response P-selectin-ADP Baseline (0 hours)
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1540 μM
Standard Deviation 323.2
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Maximal Response P-selectin-ADP 6 hours
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1300 μM
Standard Deviation 426.5
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Maximal Response P-selectin-CRP Baseline (0 hours)
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3180 μM
Standard Deviation 820.9
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Maximal Response P-selectin-CRP 6 hours
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2941 μM
Standard Deviation 891.2
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Maximal Response P-selectin-TRAP-6 Baseline (0 hours)
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3813 μM
Standard Deviation 784.8
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Change in Platelet Reactivity After Acute Consumption of SPVCE
Maximal Response P-selectin-TRAP-6 6 hours
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3700 μM
Standard Deviation 781.1
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SECONDARY outcome
Timeframe: Baseline and up to 2 hours post-interventionBlood glucose concentrations will be measured at baseline and postprandial time, 2 hours after consuming 10 g SPVCE. The aim is to evaluate the glycemic response and potential glycemia-lowering effects of the intervention.
Outcome measures
| Measure |
SPVCE Intervention
n=30 Participants
Participants will receive a single oral dose of 10 grams of SPVCE. Platelet reactivity postprandial glycemia, polyphenols levels in plasma and PFA-200 Time closure were measured before (baseline) and after the intervention (2 hours and 6 hours).
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Change in Postprandial Blood Glucose Levels After Consumption of SPVCE
Glucose levels Baseline (0 hours)
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87.37 mg/dL
Standard Deviation 6.24
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Change in Postprandial Blood Glucose Levels After Consumption of SPVCE
Glucose levels 2 hours
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85.89 mg/dL
Standard Deviation 7.94
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SECONDARY outcome
Timeframe: 0 minutes (baseline) 2 hour and 6 hours postprandial.This outcome assesses the effect of consuming SPVCE on plasma concentrations of total polyphenols. Samples were analyzed using validated spectrophotometric methods. Unit of measure: mg GAE/uL plasma.
Outcome measures
| Measure |
SPVCE Intervention
n=30 Participants
Participants will receive a single oral dose of 10 grams of SPVCE. Platelet reactivity postprandial glycemia, polyphenols levels in plasma and PFA-200 Time closure were measured before (baseline) and after the intervention (2 hours and 6 hours).
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Change in Postprandial Plasma Concentration of Total Polyphenols After Consumption of SPVCE
Polyphenols concentration at Baseline (0 hours)
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624.9 mg GAE/uL plasma
Interval 415.0 to 1035.0
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Change in Postprandial Plasma Concentration of Total Polyphenols After Consumption of SPVCE
Polyphenols concentration at 2 hours
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794.6 mg GAE/uL plasma
Interval 592.1 to 1046.0
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Change in Postprandial Plasma Concentration of Total Polyphenols After Consumption of SPVCE
Polyphenols concentration at 6 hours
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670.5 mg GAE/uL plasma
Interval 478.9 to 896.8
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SECONDARY outcome
Timeframe: Baseline (0 hours) and 6 hour post-intervention.Platelet function will be evaluated using the PFA-200 system with collagen/ADP (Col/ADP) cartridges. Closure time (in seconds) reflects platelet aggregation under high shear conditions. Measurements will be performed at baseline (0 hours) and 6 hour after consumption of SPVCE.
Outcome measures
| Measure |
SPVCE Intervention
n=19 Participants
Participants will receive a single oral dose of 10 grams of SPVCE. Platelet reactivity postprandial glycemia, polyphenols levels in plasma and PFA-200 Time closure were measured before (baseline) and after the intervention (2 hours and 6 hours).
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Change in Postprandial Platelet Function (Closure Time) After Consumption of SPVCE
Blood Risk PFA-200 6 hours
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113.9 seconds
Standard Deviation 31.94
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Change in Postprandial Platelet Function (Closure Time) After Consumption of SPVCE
Blood Risk PFA-200 Baseline (0 hours)
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118.9 seconds
Standard Deviation 28.95
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Adverse Events
SPVCE Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place