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

NCT07076563 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-07-22

No results posted yet for this study

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)

Conditions

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.

Sponsors & Collaborators

  • Centro de Estudios en Alimentos Procesados

    collaborator OTHER

  • University of Talca

    lead OTHER

Principal Investigators

  • Ivan F Palomo González, PhD. Biomedical Science · University of Talca

  • Eduardo J Fuentes Quinteros, PhD. Science research · University of Talca

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-26
Primary Completion
2025-09-05
Completion
2025-09-05

Countries

  • Chile

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07076563 on ClinicalTrials.gov