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ACTIVE NOT RECRUITING
NCT07076563
NA

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

Sponsor: University of Talca

View on ClinicalTrials.gov

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)

Official title: Chronic Effects of Ice Cream Enriched With Cimarrón Bean Extrudate on Metabolic and Cardiovascular Risk Markers: A Randomized Crossover Clinical Trial in Adults

Key Details

Gender

All

Age Range

20 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-05-26

Completion Date

2025-09-05

Last Updated

2025-07-22

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Functional Ice Cream with Cimarrón Bean Extrudate

Ice cream containing 10 g of Cimarrón bean extruded (Phaseolus vulgaris L., local variety "Cimarrón") 100 g per portion. Participants consume 100 g daily (two 50 g portions, \~2 hours after a main meal) for 4 weeks.

DIETARY_SUPPLEMENT

Placebo Ice Cream

Ice cream without Cimarrón bean extrudate, matched in appearance, taste, and texture to the functional ice cream. Participants consume 100 g daily (two 50 g portions) for 4 weeks.

Locations (1)

Universidad de Talca

Talca, Maule Region, Chile