Cimarrón Bean Extrudate Solution on Platelet Function and Biochemical Parameters

NCT ID: NCT07043829

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-13
• Study Completion Date: 2025-06-19

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 (SAEP: Solution of Cimarrón Bean Extrudate in Water).

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.

Conditions

Platelet Aggregation; Postprandial Glucose

Keywords

Phaseolus vulgaris; Platelet reactivity; Funtional food; Legume-base food; Platelet aggregation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

SAEP Intervention

Participants will receive a single oral dose of 10 grams of Cimarrón bean extrudate dissolved in water. Platelet reactivity and postprandial glycemia will be measured before and after the intervention.

Group Type: EXPERIMENTAL

SAEP (Solution of Cimarrón Bean Extrudate in Water)

Intervention Type: DIETARY_SUPPLEMENT

A single oral dose of 10 grams of Cimarrón bean (Phaseolus vulgaris, variety Cimarrón) extrudate dissolved in 500 mL of water, consumed once under fasting conditions. Used to evaluate acute effects on platelet function and postprandial glycemia.

Interventions

SAEP (Solution of Cimarrón Bean Extrudate in Water)

A single oral dose of 10 grams of Cimarrón bean (Phaseolus vulgaris, variety Cimarrón) extrudate dissolved in 500 mL of water, consumed once under fasting conditions. Used to evaluate acute effects on platelet function and postprandial glycemia.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro de Estudios en Alimentos Procesados

OTHER

Sponsor Role: collaborator

University of Talca

OTHER

Sponsor Role: lead

Responsible Party

Iván Palomo González

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivan F Palomo Gonzalez, PhD. Biomedical Science

Role: PRINCIPAL_INVESTIGATOR

University of Talca

Eduardo J Fuentes Quinteros, PhD. Science research

Role: STUDY_CHAIR

University of Talca

Locations

Universidad de Talca

Talca, Maule Region, Chile

Countries

Chile

Other Identifiers

PCSAEPF29-2021

Identifier Type: -

Identifier Source: org_study_id