Cimarrón Bean Extrudate Solution on Platelet Function and Biochemical Parameters (CBE-SP)

University of Talca

Status: Completed

Conditions: Postprandial Glucose; Platelet Aggregation

Treatments: Dietary Supplement: SAEP (Solution of Cimarrón Bean Extrudate in Water)

Study type: Interventional

Funder types: Other

Identifiers

NCT07043829

PCSAEPF29-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

SAEP Intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: SAEP (Solution of Cimarrón Bean Extrudate in Water)