NCT07053267

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

Effects of Acute Consumption of Ice Cream Enriched With Cimarron Bean Extruded on Metabolic Responses in Adults: A Non-Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Talca · Academic / Other
• Sex: All
• Age: 20 Years – 59 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
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.

Timeline

• Start date: 2025-05-26
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2025-07-08
• Last updated: 2025-07-08

Locations

1 site across 1 country: Chile