Cimarrón Bean Extrudate Solution on Platelet Function and Biochemical Parameters

NCT07043829 | Completed Results

• 1 other identifier: PCSAEPF29-2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Activation; Postprandial Glucose

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Platelet Reactivity After Acute Consumption of SPVCE

  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.

  Baseline (0 hours) and 6 hours post-intervention

Secondary Outcomes (3)

• Change in Postprandial Blood Glucose Levels After Consumption of SPVCE

  Baseline and up to 2 hours post-intervention

• Change in Postprandial Plasma Concentration of Total Polyphenols After Consumption of SPVCE

  0 minutes (baseline) 2 hour and 6 hours postprandial.

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

  Baseline (0 hours) and 6 hour post-intervention.

Study Arms (1)

SPVCE Intervention

EXPERIMENTAL

Participants will receive a single oral dose of 10 grams of SPVCE. Platelet function (Reactivity and blood risk), postprandial glycemia and Polyphenol concentration will be measured before and after the intervention.

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

Interventions

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.

Also known as: SAEP (Solution of Cimarrón Bean Extrudate in Water)

SPVCE Intervention

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntary participant
• Men and women aged 20-59 years
• Willingness to participate and provide written informend consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Talca: lead
• Centro de Estudios en Alimentos Procesados: collaborator

Study Sites (1)

Universidad de Talca

Talca, Maule Region, 3460057, Chile

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Iván Francisco Palomo González
• Organization: University of Talca

ipalomo@utalca.cl

+56 (71) 200495

Study Officials

• Ivan F Palomo Gonzalez, PhD. Biomedical Science

  University of Talca

  PRINCIPAL INVESTIGATOR

• Eduardo J Fuentes Quinteros, PhD. Science research

  University of Talca

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: March 13, 2025
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: April 9, 2026
• Results First Posted: April 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)