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

NCT ID: NCT07076563

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-26
• Study Completion Date: 2025-09-05

Brief 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)

Detailed Description

This randomized, single-blind, crossover clinical trial assesses the effects of daily consumption of a functional ice cream enriched with Cimarrón bean extrudate (Phaseolus vulgaris L., local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor.

Eligible participants are adults (20-59 years) health or present at least one cardiovascular risk factor (e.g., smoking, insulin resistance, overweight/obesity, hypertension) and a BMI between 18.5 and 39.9 kg/m^2.

Participants are randomized into two groups (Alfa and Gamma) to receive either the placebo or functional ice cream first. Each intervention period lasts 4 week during which participants consume 100 g/day of the assigned ice cream (two 50 g portions, ~2 hours after a main meal). Following a 3-week washout period, participants switch to the alternate intervention. At the beginning and end of each intervention period, anthropometric assessments are performed, including body weight, height, body mass index (BMI), waist circumference, and mid-upper arm circumference. Additionally, fasting blood samples are collected to assess glucose, insulin, lipid profile, complete blood count plus erythrocyte sedimentation rate, HbA1c, and blood pressure.

The placebo or functional ice cream are organoleptically identical to ensure blinding. Randomization is stratified by sex, age, and BMI using balanced block randomization with R software (v4.5.0).

The primary outcomes are the within-subject changes in serum glucose and serum insulin concentrations between the intervention and placebo phases.

The Secondary outcomes include within-subject changes in:

• Lipid profile parameters: total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, and the total cholesterol/HDL-c ratio.
• Anthropometric measurements: body weight, waist circumference, arm circumference, and body mass index (BMI).
• Blood pressure: systolic and diastolic, measured after rest.

Other Pre-specified Outcomes Glycemic control: Hemoglobin A1c (HbA1c).

• Liver and kidney function markers: including serum aspartate aminotransferase (AST), creatinine, and urea.
• Coagulation marker: Prothrombin time (PT).
• Complete blood count (CBC): including hemoglobin, white blood cell count, red blood cell count, and platelet count.
• Monitor systemic inflammatory status: Erythrocyte sedimentation rate (ESR)
• Adherence to the intervention (measured by portion tracking and consumption logs).
• Gastrointestinal symptom frequency (assessed via participant questionnaires).
• Product acceptability and palatability (evaluated using Likert-scale surveys).
• Participant-reported adverse events (monitored continuously throughout the intervention).

Conditions

Cardiovascular Risk Factors; Insulin Resistance; Overweight (BMI > 25)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Placebo Ice Cream

Participants consume 100 g/day of placebo ice cream for 4 weeks. The placebo ice cream is organoleptically identical to the intervention but does not contain Cimarrón bean extrudate. After a washout period, participants cross over to the intervention arm.

Group Type: PLACEBO_COMPARATOR

Placebo Ice Cream

Intervention Type: DIETARY_SUPPLEMENT

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.

Functional Ice Cream Enriched with Cimarrón Bean Extrudate

Participants consume 100 g/day of ice cream enriched with 10 g of Cimarrón bean extrudate for 4 weeks. After a washout period, participants cross over to the placebo arm.

Group Type: EXPERIMENTAL

Functional Ice Cream with Cimarrón Bean Extrudate

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Documented food allergies, especially to legumes or beans
• Diagnosed liver, kidney, autoimmune 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro de Estudios en Alimentos Procesados

OTHER

Sponsor Role: collaborator

University of Talca

OTHER

Sponsor Role: lead

Responsible Party

Iván Palomo González

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivan F Palomo González, PhD. Biomedical Science

Role: PRINCIPAL_INVESTIGATOR

University of Talca

Eduardo J Fuentes Quinteros, PhD. Science research

Role: PRINCIPAL_INVESTIGATOR

University of Talca

Locations

Universidad de Talca

Talca, Maule Region, Chile

Countries

Chile

Other Identifiers

CH-HEP-UTALCA-F29-2021

Identifier Type: -

Identifier Source: org_study_id