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Completed

NCT Number: NCT07053267

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

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.

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Key information

Conditions

Cardiovascular Disease Risk Factor Body Weight Glucose Metabolism Disorders Hyperglycaemia Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Overweight (BMI > 25) Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Talca

Talca, Maule Region, 3460057, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Funrional Ice Cream

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

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.

Primary outcomes

  1. Change in Postprandial Glucose Concentration

    Time frame: 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.

  2. Change in Postprandial Insulin Concentration

    Time frame: 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 outcomes

  1. Change in Postprandial Lipid Profile

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Talca

Other

Collaborators

  • Centro de Estudios en Alimentos Procesados

Registry information

Official study title

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

Acronym: ICE-CBE-GLULIP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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