An interventional study of SPVCE (Solution Phaseolus vulgaris L. var. Cimarrón Extrudate in Water) in Postprandial Glucose and Platelet Activation, sponsored by University of Talca. Completed at 1 site in Chile. Open to participants aged 20 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by University of Talca · Not applicable, Interventional, and Basic science
This non-randomized acute clinical trial evaluates the effect of consuming a water-based solution of Cimarrón bean extrudate on platelet function and postprandial glycemia in adults.
Participants will consume a single 10-gram dose of Cimarrón bean extrudate dissolved in water. Blood samples will be collected before and after the intervention to assess platelet reactivity using flow cytometry and to measure glucose levels through colorimetric spectrophotometry. The total intervention period will last approximately 8 hours. This study aims to explore whether the acute consumption of this legume-based functional product can influence hemostatic and glycemic responses in the postprandial state.
This clinical trial aims to evaluate the acute effects of consuming a beverage made from Cimarrón bean extrudate on platelet function and postprandial blood glucose levels in adult participants. The study involves a single-arm, non-randomized, open-label design in which each participant will consume a single oral dose of 10 grams of Cimarrón bean extrudate dissolved in water (SPVCE: Solution Phaseolus vulgaris L var. Cimarrón extrudate)
The trial includes baseline and post-intervention assessments of platelet reactivity using flow cytometry, employing specific agonists (CRP, TRAP, ADP) and labeled antibodies (anti-fibrinogen FITC, PE-CD61/CD62). Blood glucose levels will also be measured at multiple time points using colorimetric spectrophotometry to evaluate postprandial metabolic response.
The total study duration per participant is approximately 8 hours, including fasting baseline measurements, administration of the intervention, and postprandial monitoring. This study seeks to provide preliminary data on the potential hemostatic and glycemic effects of a legume-derived functional food ingredient in a controlled, acute setting.
University of Talca is the lead sponsor of 16 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: 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 (reactivity and blood risk), postprandial glycemia, and total polyphenol concentration at baseline (0 hours), 2 hours, and 6 hours after SPVCE consumption.
Also known as: SAEP (Solution of Cimarrón Bean Extrudate in Water)
Change in Platelet Reactivity After Acute Consumption of SPVCE
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.
Time frame: Baseline (0 hours) and 6 hours post-intervention
Change in Postprandial Blood Glucose Levels After Consumption of SPVCE
Blood 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.
Time frame: Baseline and up to 2 hours post-intervention
Change in Postprandial Plasma Concentration of Total Polyphenols After Consumption of SPVCE
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.
Time frame: 0 minutes (baseline) 2 hour and 6 hours postprandial.
Change in Postprandial Platelet Function (Closure Time) After Consumption of SPVCE
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.
Time frame: Baseline (0 hours) and 6 hour post-intervention.
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.
| Milestone | SPVCE Intervention |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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.
| μM | SPVCE Intervention |
|---|---|
| Sensibility Fibrinogen- ADP EC50 Baseline (0 hours) | 0.23 ± 0.13 |
| Sensibility Fibrinogen- ADP EC50 6 hours | 0.16 ± 0.11 |
| Sensibility Fibrinogen- CRP EC50 Baseline (0 hours) | 0.05 ± 0.02 |
| Sensibility Fibrinogen- CRP EC50 6 hours | 0.05 ± 0.03 |
| Sensibility Fibrinogen-TRAP-6 EC50 Baseline (0 hours) | 1.96 ± 0.72 |
| Sensibility Fibrinogen-TRAP-6 EC50 6 hours | 1.47 ± 0.46 |
| Sensibility P-selectin- ADP EC50 Baseline (0 hours) | 0.60 ± 0.19 |
| Sensibility P-selectin- ADP EC50 6 hours | 0.52 ± 0.16 |
| Sensibility P-selectin- CRP EC50 Baseline (0 hours) | 0.05 ± 0.03 |
| Sensibility P-selectin- CRP EC50 6 hours | 0.05 ± 0.03 |
| Sensibility P-selectin-TRAP-6 EC50 Baseline (0 hours) | 3.09 ± 1.18 |
| Sensibility P-selectin-TRAP-6 EC50 6 hours | 2.5 ± 0.59 |
| Capacity Fibrinogen-ADP baseline (0 hours) | 887.2 ± 133.0 |
| Capacity Fibrinogen-ADP 6 hours | 918.4 ± 114.5 |
| Capacity Fibrinogen- CRP baseline (0 hours) | 845.1 ± 248.5 |
| Capacity Fibrinogen-CRP 6 hours | 828.8 ± 243.9 |
| Capacity Fibrinogen-TRAP-6 Baseline (0 hours) | 1233 ± 233.1 |
| Capacity Fibrinogen-TRAP-6 6 hours | 1251 ± 193.0 |
| Capacity P-selectin-ADP baseline (0 hours) | 1177 ± 279.3 |
| Capacity P-selectin ADP 6 hours | 1092 ± 289.8 |
| Capacity P-selectin-CRP baseline (0 hours) | 2711 ± 726.5 |
| Capacity P-selectin CRP 6 hours | 2628 ± 602.5 |
| Capacity P-selectin-TRAP-6 baseline (0 hours) | 3378 ± 746.4 |
| Capacity P-selectin-TRAP-6 6 hours | 3450 ± 711.5 |
| Basal Activity (Minimun) Fibrinogen-ADP Baseline (0 hours) | 1145 ± 254.9 |
| Basal Activity (Minimum) Fibrinogen-ADP 6 hours | 1011 ± 188.7 |
| Basal Activity Fibrinogen-CRP Baseline (0 hours) | 1043 ± 217.1 |
| Basal activity Fibrinogen-CRP 6 hours | 968.2 ± 122.5 |
| Basal Activity Fibrinogen-TRAP-6 Baseline (0 hours) | 1069 ± 228.9 |
| Basal Activity Fibrinogen-TRAP-6 6 hours | 986.1 ± 162.1 |
| Basal Activity P-selectin-ADP Baseline (0 hours) | 471.3 ± 132.7 |
| Basal Activity P-selectin-ADP 6 hours | 319.5 ± 127.8 |
| Basal Activity P-selectin-CRP Baseline (0 hour) | 516.5 ± 138.3 |
| Basal Activity P-selectin-CRP 6 hours | 354.5 ± 167.0 |
| Basal Activity P-selectin-TRAP-6 Baseline (0 hours) | 482.5 ± 140.9 |
| Basal Actitivy P-selectin-TRAP-6 6 hours | 313.5 ± 117.8 |
| Maximal Response Fibrinogen-ADP Baseline (0 hours) | 1764 ± 280.6 |
| Maximal Response Fibrinogen-ADP 6 hours | 1555 ± 242.5 |
| Maximal Response Fibrinogen-CRP Baseline (0 hours) | 1730 ± 424.2 |
| Maximal Response Fibrinogen-CRP 6 hours | 1500 ± 338.8 |
| Maximal Response Fibrinogen-TRAP-6 Baseline (0 hours) | 2098 ± 394.0 |
| Maximal Response Fibrinogen-TRAP-6 6 hours | 1934 ± 285.4 |
| Maximal Response P-selectin-ADP Baseline (0 hours) | 1540 ± 323.2 |
| Maximal Response P-selectin-ADP 6 hours | 1300 ± 426.5 |
| Maximal Response P-selectin-CRP Baseline (0 hours) | 3180 ± 820.9 |
| Maximal Response P-selectin-CRP 6 hours | 2941 ± 891.2 |
| Maximal Response P-selectin-TRAP-6 Baseline (0 hours) | 3813 ± 784.8 |
| Maximal Response P-selectin-TRAP-6 6 hours | 3700 ± 781.1 |
Blood 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.
| mg/dL | SPVCE Intervention |
|---|---|
| Glucose levels Baseline (0 hours) | 87.37 ± 6.24 |
| Glucose levels 2 hours | 85.89 ± 7.94 |
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.
| mg GAE/uL plasma | SPVCE Intervention |
|---|---|
| Polyphenols concentration at Baseline (0 hours) | 624.9 (415.0 to 1035) |
| Polyphenols concentration at 2 hours | 794.6 (592.1 to 1046) |
| Polyphenols concentration at 6 hours | 670.5 (478.9 to 896.8) |
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.
| seconds | SPVCE Intervention |
|---|---|
| Blood Risk PFA-200 Baseline (0 hours) | 118.9 ± 28.95 |
| Blood Risk PFA-200 6 hours | 113.9 ± 31.94 |
Collected over From the start of the intervention until 8 hours post-intervention. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SPVCE Intervention | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | SPVCE Intervention |
|---|---|
| Mean | 29.9 ± 10.45 |
| Sex: Female, Male(Participants) | SPVCE Intervention |
|---|---|
| Female | 18 |
| Male | 12 |
| Race and Ethnicity Not Collected(Participants) | SPVCE Intervention |
|---|
| Height(meters) | SPVCE Intervention |
|---|---|
| Mean | 1.63 ± 0.077 |
| Weight(kilograms) | SPVCE Intervention |
|---|---|
| Mean | 70 ± 13.5 |
| Body Mass Index (BMI)(Kg/m^2) | SPVCE Intervention |
|---|---|
| Mean | 26.28 ± 3.4 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data (IPD) will not be shared. As stated in the informed consent, participation is strictly confidential; participant names and identifiers are not used. Blood samples are coded and not linked to personal data. Identity and health information will not be disclosed or shared outside the study team.
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