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

University of Talca20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Interventions

Funrional Ice CreamDIETARY_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 CreamDIETARY_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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Postprandial Glucose Concentration

Blood glucose levels will be measured at fasting (baseline) and at 120 minutes following the intake of either functional or placebo ice cream. Outcome will be expressed in mg/dL.

Time frame: Baseline and 120 minutes after consumption

Change in Postprandial Insulin Concentration

Blood insulin levels will be assessed at fasting and at 120 minutes post-consumption. Outcome will be expressed in µIU/mL.

Time frame: Baseline and 120 minutes after consumption

Secondary Outcomes

Change in Postprandial Lipid Profile

Total cholesterol, HDL-c, LDL-c, and triglycerides will be measured at baseline and at 120 minutes post-consumption. Values will be expressed in mg/dL.

Time frame: Baseline and 120 minutes after consumption.