Ice Cream Enriched With Cimarrón Bean Extrudate and Cardiovascular Risk in Adults

NCT07076563 | Active Not Recruiting

• 1 other identifier: CH-HEP-UTALCA-F29-2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the chronic effects of consuming a functional ice cream enriched with Cimarrón bean (Phaseolus vulgaris local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor. The main question it aims to answer is:

• Does chronic daily consumption of the functional ice cream with Cimarrón bean extrudate improve fasting glucose, insulin, lipid profile, and other cardiovascular risk markers? Researchers will compare a functional ice cream containing 10 g of extrudate per100 g to a placebo version without extrudate, using a crossover design in which participants consume both versions for 4 weeks each, separated by a 3-week washout period to determine metabolic responses. Participants will:
• Attend clinical visits in fasting conditions at the beginning and end of each 4-week intervention to provide blood samples for glucose, insuli, lipid profile, complete blood count plus Erythrocyte sedimentation rate and HbA1c assessment.
• Undergo anthroprometric measurements and blood pressure assessment at the beginning and end of each 4-week intervention.
• Consume 100g/day of the assigned ice cream during each phase (Two phases)

Conditions

Cardiovascular Risk Factors; Insulin Resistance; Overweight (BMI > 25)

Keywords

Phaseolus vulgaris; Funtional food; Legume-base food; cardiovascular disease; cardiovascular risk

Outcome Measures

Primary Outcomes (2)

• Change in Serum Glucose

  Venous blood samples will be collected at the beginning and end of each 4-week intervention phase to measure fasting serum glucose levels. The primary outcome is the within-subject difference in glucose concentration between the placebo and intervention periods. Values will be expressed in mg/dL.

  Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)

• Change in Serum Insulin

  Venous blood samples will be collected at the beginning and end of each 4-week intervention phase to measure fasting serum insulin levels. The primary outcome is the within-subject difference in insulin concentration between the placebo and intervention periods. Values will be expressed in µIU/mL.

  Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)

Secondary Outcomes (10)

• Change in Total Cholesterol

  Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)

• Change in Triglycerides

  Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)

• Change in HDL Cholesterol (HDL-c)

  Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)

• Change in LDL Cholesterol (LDL-c)

  Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)

• Change in Total Cholesterol to HDL-c Ratio

  Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)

Other Outcomes (14)

• Change in Hemoglobin A1c (HbA1c)

  Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)

• Change in Serum Aspartate Aminotransferase (AST)

  Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)

• Change in Serum Creatinine

  Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)

Study Arms (2)

Placebo Ice Cream

PLACEBO COMPARATOR

Participants consume 100 g/day of placebo ice cream for 4 weeks. The placebo ice cream is organoleptically identical to the intervention but does not contain Cimarrón bean extrudate. After a washout period, participants cross over to the intervention arm.

Dietary Supplement: Placebo Ice Cream

Functional Ice Cream Enriched with Cimarrón Bean Extrudate

EXPERIMENTAL

Participants consume 100 g/day of ice cream enriched with 10 g of Cimarrón bean extrudate for 4 weeks. After a washout period, participants cross over to the placebo arm.

Dietary Supplement: Functional Ice Cream with Cimarrón Bean Extrudate

Interventions

Functional Ice Cream with Cimarrón Bean Extrudate DIETARY_SUPPLEMENT

Ice cream containing 10 g of Cimarrón bean extruded (Phaseolus vulgaris L., local variety "Cimarrón") 100 g per portion. Participants consume 100 g daily (two 50 g portions, \~2 hours after a main meal) for 4 weeks.

Functional Ice Cream Enriched with Cimarrón Bean Extrudate

Placebo Ice Cream DIETARY_SUPPLEMENT

Ice cream without Cimarrón bean extrudate, matched in appearance, taste, and texture to the functional ice cream. Participants consume 100 g daily (two 50 g portions) for 4 weeks.

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; Cardiovascular Diseases

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: 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: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized, single-blind, crossover clinical trial with two arms: one receiving a functional ice cream enriched with 10 g of Cimarrón bean extrudate (intervention) and one receiving a placebo ice cream (control), both matched for appearance and taste. Participants are randomly assigned to one of two groups (Alfa or Gamma). Each participant undergoes two intervention phases, each lasting four weeks, separated by washout period. The order of receiving the intervention or placebo is randomized. During each intervention period, participants consume 100 g/day of the assigned ice cream. Fasting blood samples and anthropometric data are collected at the beginning and end of each phase. Randomization is performed using block randomization stratified by sex, age, and body mass index (BMI), to ensure balance across treatment sequences. This crossover model allows each participant to serve as their own control, reducing inter-individual variability and increasing statistical power

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 22, 2025
• Study Start: May 26, 2025
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

CL (1)