Acute Postprandial Effects of Functional Ice Cream With Cimarrón Bean Extrudate in Adults (ICE-CBE-GLULIP)

University of Talca

Status: Completed

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

Treatments: Dietary Supplement: Funrional Ice Cream; Dietary Supplement: Placebo Ice Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT07053267

ACU-HEP-UTALCA-F29-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups, including a placebo group

Functional Ice Cream with Cimarrón Bean Extrudate

Experimental group

Description:

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

Treatment:

Dietary Supplement: Funrional Ice Cream

Placebo Ice Cream

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo Ice Cream