Active — Not RecruitingNot Applicable

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

Chile80 participantsStarted 2025-05-26

Plain-language 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)

Who can participate

Age range

20 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Serum Glucose

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

Change in Serum Insulin

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

Trial details

NCT IDNCT07076563

SponsorUniversity of Talca

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-05

View on ClinicalTrials.gov More Cardiovascular Risk Factors trials