Clinical Trial

Ice Cream Enriched With Cimarrón Bean Extrudate and Cardiovascular Risk in Adults

Study acronym: ICE-CBE-CARD
Active, Not Recruiting
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Record status
This record was last updated July 22, 2025 (before its estimated September 5, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to evaluate the chronic effects of consuming a functional ice cream enriched with Cimarrón bean (Phaseolus vulgaris local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor. The main question it aims to answer is: * Does chronic daily consumption of the functional ice cream with Cimarrón bean extrudate improve fasting glucose, insulin, lipid profile, and other cardiovascular risk markers? Researchers will compare a functional ice cream containing 10 g of extrudate per100 g to a placebo version without extrudate, using a crossover design in which participants consume both versions for 4 weeks each, separated by a 3-week washout period to determine metabolic responses. Participants will: * Attend clinical visits in fasting conditions at the beginning and end of each 4-week intervention to provide blood samples for glucose, insuli, lipid profile, complete blood count plus Erythrocyte sedimentation rate and HbA1c assessment. * Undergo anthroprometric measurements and blood pressure assessment at the beginning and end of each 4-week intervention. * Consume 100g/day of the assigned ice cream during each phase (Two phases)
Trial Details
NCT Number NCT07076563
Lead Sponsor University of Talca
Collaborators: Centro de Estudios en Alimentos Procesados
Conditions Cardiovascular Risk Factors, Insulin Resistance, Overweight (BMI > 25)
Enrollment 80 participants
Start Date 2025-05-26
Primary Completion 2025-09-05 (estimated)
Study Completion 2025-09-05 (estimated)
Updated on ClinicalTrials.gov 2025-07-22