Universidad de Talca
Talca, Maule Region, 3460057, Chile
NCT Number: NCT07043829
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.
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Notify Me20 year–59 year
All sexes
Interventional
Not applicable
Talca, Maule Region, 3460057, Chile
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: SAEP (Solution of Cimarrón Bean Extrudate in Water)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University of Talca
Other
Effect of Consuming a Cimarrón Bean Extrudate Solution on Platelet Function and Postprandial Biochemical Parameters
Acronym: CBE-SP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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