Acute Postprandial Effects of Functional Ice Cream With Cimarrón Bean Extrudate in Adults

NCT ID: NCT07053267

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-26
• Study Completion Date: 2025-05-30

Brief Summary

The goal of this non-randomized clinical trial is to evaluate the acute postprandial metabolic effects of a functional ice cream enriched with Cimarrón bean (Phaseolus vulgaris L. local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor.

The main questions it aims to answer are:

• Does the functional ice cream reduce postprandial glucose and insulin levels?
• Does it affect postprandial lipid concentrations?

Researchers will compare participants receiving a single dose of the functional ice cream containing 10 g of extrudate per 100 g to placebo version without extrudate, both ice creams are identical in appearance and taste.

Participants will:

• Attend a clinical visit in fasting conditions (10-12 hours).
• Provide baseline blood samples for glucose, insulin, and lipid profile.
• Consume a single 100 g portion of functional or placebo ice cream.
• Provide postprandial blood samples at defined time points.

Detailed Description

This Study trial is to evaluate the acute postprandial metabolic effects of a functional ice cream with Cimarrón bean (Phaseolus vulgaris L. local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor.

It is a non-randomized, single-blind, parallel-group clinical trial with two arms: intervention (functional ice cream) and control (placebo ice cream). Both products are matched for texture, flavor, and appearance to maintain participant blinding.

Participants arrive at the clinic after a 10-12 hour fast. Baseline blood samples are collected for glucose, insulin, and lipid profile. They then consume one 100 g portion of the assigned ice cream. Blood samples are collected postprandially at 120 minutes to assess changes in glucose, insulin and lipid profile.

The study aims to determine whether the functional ice cream modifies postprandial glycemic and lipemic responses, providing insight into its potential use as a dietary strategy to reduce cardiometabolic risk.

Conditions

Cardiovascular Disease Risk Factor; Insulin Resistance; Overweight (BMI > 25); Hyperglycaemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Functional Ice Cream with Cimarrón Bean Extrudate

Participants consume a single 100 g portion of ice cream enriched with 10 g Cimarrón bean extrudate.

Group Type: EXPERIMENTAL

Funrional Ice Cream

Intervention Type: DIETARY_SUPPLEMENT

Single 100 g serving of ice cream enriched with 10 g of Cimarrón bean extrudate, administered after an overnight fast to evaluate postprandial metabolic responses.

Placebo Ice Cream

Participants consume a single 100 g portion of placebo ice cream identical in appearance and flavor, but without the Cimarrón bean extrudate.

Group Type: PLACEBO_COMPARATOR

Placebo Ice Cream

Intervention Type: DIETARY_SUPPLEMENT

Single 100 g serving of placebo ice cream identical in flavor, texture, and appearance, but without Cimarrón bean extrudate, administered after an overnight fast to evaluate postprandial metabolic responses.

Interventions

Funrional Ice Cream

Single 100 g serving of ice cream enriched with 10 g of Cimarrón bean extrudate, administered after an overnight fast to evaluate postprandial metabolic responses.

Intervention Type: DIETARY_SUPPLEMENT

Placebo Ice Cream

Single 100 g serving of placebo ice cream identical in flavor, texture, and appearance, but without Cimarrón bean extrudate, administered after an overnight fast to evaluate postprandial metabolic responses.

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

ACU-HEP-UTALCA-F29-2021

Identifier Type: -

Identifier Source: org_study_id