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Completed

NCT Number: NCT07043829

Cimarrón Bean Extrudate Solution on Platelet Function and Biochemical Parameters

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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Key information

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Talca

Talca, Maule Region, 3460057, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SPVCE (Solution Phaseolus vulgaris L. var. Cimarrón Extrudate in Water)

Dietary Supplement

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)

Primary outcomes

  1. Change in Platelet Reactivity After Acute Consumption of SPVCE

    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.

Secondary outcomes

  1. Change in Postprandial Blood Glucose Levels After Consumption of SPVCE

    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.

  2. Change in Postprandial Plasma Concentration of Total Polyphenols After Consumption of SPVCE

    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.

  3. Change in Postprandial Platelet Function (Closure Time) After Consumption of SPVCE

    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.

Sponsors and collaborators

Lead sponsor

University of Talca

Other

Collaborators

  • Centro de Estudios en Alimentos Procesados

Registry information

Official study title

Effect of Consuming a Cimarrón Bean Extrudate Solution on Platelet Function and Postprandial Biochemical Parameters

Acronym: CBE-SP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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