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)
This randomized, single-blind, crossover clinical trial assesses the effects of daily consumption of a functional ice cream enriched with Cimarrón bean extrudate (Phaseolus vulgaris L., local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor. Eligible participants are adults (20-59 years) health or present at least one cardiovascular risk factor (e.g., smoking, insulin resistance, overweight/obesity, hypertension) and a BMI between 18.5 and 39.9 kg/m\^2. Participants are randomized into two groups (Alfa and Gamma) to receive either the placebo or functional ice cream first. Each intervention period lasts 4 week during which participants consume 100 g/day of the assigned ice cream (two 50 g portions, \~2 hours after a main meal). Following a 3-week washout period, participants switch to the alternate intervention. At the beginning and end of each intervention period, anthropometric assessments are performed, including body weight, height, body mass index (BMI), waist circumference, and mid-upper arm circumference. Additionally, fasting blood samples are collected to assess glucose, insulin, lipid profile, complete blood count plus erythrocyte sedimentation rate, HbA1c, and blood pressure. The placebo or functional ice cream are organoleptically identical to ensure blinding. Randomization is stratified by sex, age, and BMI using balanced block randomization with R software (v4.5.0). The primary outcomes are the within-subject changes in serum glucose and serum insulin concentrations between the intervention and placebo phases. The Secondary outcomes include within-subject changes in: * Lipid profile parameters: total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, and the total cholesterol/HDL-c ratio. * Anthropometric measurements: body weight, waist circumference, arm circumference, and body mass index (BMI). * Blood pressure: systolic and diastolic, measured after rest. Other Pre-specified Outcomes Glycemic control: Hemoglobin A1c (HbA1c). * Liver and kidney function markers: including serum aspartate aminotransferase (AST), creatinine, and urea. * Coagulation marker: Prothrombin time (PT). * Complete blood count (CBC): including hemoglobin, white blood cell count, red blood cell count, and platelet count. * Monitor systemic inflammatory status: Erythrocyte sedimentation rate (ESR) * Adherence to the intervention (measured by portion tracking and consumption logs). * Gastrointestinal symptom frequency (assessed via participant questionnaires). * Product acceptability and palatability (evaluated using Likert-scale surveys). * Participant-reported adverse events (monitored continuously throughout the intervention).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
80
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.
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.
Universidad de Talca
Talca, Maule Region, Chile
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.
Time frame: 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.
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Change in Total Cholesterol
Fasting serum total cholesterol will be measured at the beginning and end of each 4-week intervention phase. The outcome is the within-subject difference between the placebo and intervention periods. Values will be expressed in mg/dL.
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Change in Triglycerides
Fasting serum Triglycerides will be measured at the beginning and end of each 4-week intervention phase. The outcome is the within-subject difference between the placebo and intervention periods. Values will be expressed in mg/dL.
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Change in HDL Cholesterol (HDL-c)
Fasting serum HDL-c will be measured at the beginning and end of each 4-week intervention phase. The outcome is the within-subject difference between the placebo and intervention periods. Values will be expressed in mg/dL.
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Change in LDL Cholesterol (LDL-c)
Fasting serum LDL-c will be measured at the beginning and end of each 4-week intervention phase. The outcome is the within-subject difference between the placebo and intervention periods. Values will be expressed in mg/dL.
Time frame: 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
The ratio of total cholesterol to HDL-c will be calculated at baseline and after 4 weeks in each treatment period. The outcome is the within-subject difference between placebo and intervention. This value is unitless.
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Change in Waist Circumference
Waist circumference will be measured in centimeters using a non-elastic tape, to assess abdominal adiposity. The outcome is the within-subject difference between the placebo and intervention periods.
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Change in Body Mass Index (BMI)
BMI will be calculated using weight (kg) and height (m\^2) at the beginning and end of each 4-week treatment period. Outcome will be expressed in kg/m\^2 as the within-subject difference between placebo and intervention.
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Change in Body Weight
Body weight will be measured using a calibrated digital scale with participants wearing light clothing and no shoes. The outcome reflects the within-subject difference in weight between placebo and intervention phases. Values will be expressed in kilograms (kg).
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Change in Blood Pressure (Systolic and Diastolic)
Blood pressure will be measured in mmHg after 5 minutes of rest, using a validated sphygmomanometer. Systolic and diastolic values will be recorded
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Change in Arm Circumference
Arm circumference will be measured in centimeters as a proxy for muscle or fat mass changes.
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
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