Platelet Activation, Postprandial Glucose
Conditions
Keywords
Phaseolus vulgaris, Platelet reactivity, Funtional food, Legume-base food, Platelet activation
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSPVCE (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.
Sponsors
University of Talca
Centro de Estudios en Alimentos Procesados
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
A single-group, open-label clinical trial in which all participants receive a single dose of a functional beverage containing 10 grams of Cimarrón bean extrudate dissolved in water. No placebo or comparator group is included. Outcomes are measured before and after the intervention within the same participants to assess acute changes in platelet function and postprandial glycemia.
Eligibility
Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Voluntary participant * Men and women aged 20-59 years * Willingness to participate and provide written informend consent
Exclusion criteria
* Documented food allergies, especially ti legumes or beans * Diagnosed liver, kidney, , autoinmune diseases or severe illnesses such as cancer. * Diagnosed gastrointestinal diseases including inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), celiac disease, or any condition causing chronic gastrointestinal symptoms such as malabsorption, persistent diarrhea, or gastrointestinal bleeding * Use medication known to alter platelet funtion like, antiplatelet agents (aspirin, clopidogrel); Non-steroidal anti-inflamatory drugs (NSAID-Ibuprofen, naproxen); Anticoagulants (Warfarin, heparin, direct oral anticoagulant like rivaroxaban or apixaban); Selective serotonin reuptake inhibitors (SSRIs) and other drugs known to impact platelet aggregation or hemostasis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Platelet Reactivity After Acute Consumption of SPVCE | Baseline (0 hours) and 6 hours post-intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Postprandial Blood Glucose Levels After Consumption of SPVCE | Baseline and up to 2 hours post-intervention | 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. |
| Change in Postprandial Plasma Concentration of Total Polyphenols After Consumption of SPVCE | 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. |
| Change in Postprandial Platelet Function (Closure Time) After Consumption of SPVCE | 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. |
Countries
Chile
Contacts
PRINCIPAL_INVESTIGATORIvan F Palomo Gonzalez, PhD. Biomedical Science
University of Talca
STUDY_CHAIREduardo J Fuentes Quinteros, PhD. Science research
University of Talca
Participant flow
Recruitment details
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.
Pre-assignment details
Participants were screened for eligibility through medical history review and fasting blood glucose measurement. Eligible participants provided written informed consent before enrollment
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29.9 years STANDARD_DEVIATION 10.45 |
| Body Mass Index (BMI) | 26.28 Kg/m^2 STANDARD_DEVIATION 3.4 |
| Height | 1.63 meters STANDARD_DEVIATION 0.077 |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 12 Participants |
| Weight | 70 kilograms STANDARD_DEVIATION 13.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
None listed