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

Not Applicable

Completed

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

• Registration Number: NCT07053267
• Lead Sponsor: University of Talca

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.

Study Timeline

• Study Start: 2025-05-26
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30
• Status Verified: 2025-06
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Postprandial Glucose Concentration	Baseline and 120 minutes after consumption	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.
Change in Postprandial Insulin Concentration	Baseline and 120 minutes after consumption	Blood insulin levels will be assessed at fasting and at 120 minutes post-consumption. Outcome will be expressed in µIU/mL.

Secondary Outcome Measures

Name	Time	Method
Change in Postprandial Lipid Profile	Baseline and 120 minutes after consumption.	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.

Trial Locations

Locations (1)

Universidad de Talca; 🇨🇱 Talca, Maule, Chile