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

NCT07053267 | Completed

• 1 other identifier: ACU-HEP-UTALCA-F29-2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Phaseolus vulgaris; Ice cream; Postprandial metabolism; Functional food; Dietary intervention; Glucose response; Insulin response; Lipid profile

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 120 minutes after consumption

Secondary Outcomes (1)

• Change in Postprandial Lipid Profile

  Baseline and 120 minutes after consumption.

Study Arms (2)

Functional Ice Cream with Cimarrón Bean Extrudate

EXPERIMENTAL

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

Dietary Supplement: Funrional Ice Cream

Placebo Ice Cream

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Ice Cream

Interventions

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.

Functional Ice Cream with Cimarrón Bean Extrudate

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.

Placebo Ice Cream

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntary participant
• Men and women aged 20-59 years
• Willingness to participate and provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Talca: lead
• Centro de Estudios en Alimentos Procesados: collaborator

Study Sites (1)

Universidad de Talca

Talca, Maule Region, 3460057, Chile

Location

MeSH Terms

Conditions

Insulin Resistance; Overweight; Hyperglycemia

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ivan F Palomo González, PhD. Biomedical Science

  University of Talca

  PRINCIPAL INVESTIGATOR

• Eduardo J Fuentes Quinteros, PhD. Science research

  University of Talca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to the intervention type (placebo vs. functional ice cream) by providing both ice creams with identical appearance, texture, and flavor. The investigators were not blinded due to the need to manage logistics and sample handling. However, participants were unaware of their group assignment to minimize bias in self-reported adherence and perception of effects.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a parallel-group clinical trial in which participants were non-randomly assigned to one of two arms: a single-dose intervention group consuming a functional ice cream enriched with Cimarrón bean extrudate, or a placebo group consuming an identical ice cream without the functional ingredient. Both groups were assessed in parallel for postprandial metabolic responses after a single intervention day.

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 8, 2025
• Study Start: May 26, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

CL (1)