Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07076563

Active, not recruitingNot applicableInterventional

What this study is about

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)

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 59 Years

SexAll

Healthy volunteersAccepted

ConditionCardiovascular Risk Factors, Insulin Resistance, Overweight (BMI > 25)

Full registry criteria

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

Treatments and study arms

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.

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.

Primary outcomes

Change in Serum GlucoseBaseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)

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.

Change in Serum InsulinBaseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Universidad de Talca🇨🇱 Talca, Maule Region, Chile

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