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| Name | Class |
|---|---|
| Centro de Estudios en Alimentos Procesados | OTHER |
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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:
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:
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:
Other Pre-specified Outcomes Glycemic control: Hemoglobin A1c (HbA1c).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) | Fasting blood samples will be analyzed to determine the within-subject difference in HbA1c levels between placebo and intervention periods. Results will be expressed as a percentage (%). | Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period) |
| Change in Serum Aspartate Aminotransferase (AST) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan F Palomo González, PhD. Biomedical Science | University of Talca | Principal Investigator |
| Eduardo J Fuentes Quinteros, PhD. Science research | University of Talca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Talca | Talca | Maule Region | 3460057 | Chile |
The plan to share individual participant data (IPD) has not yet been determined. The decision will depend on future publication plans, data management policies, and ethical considerations regarding participant privacy
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D050177 | Overweight |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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
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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.
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| 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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 | 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. | Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period) |
AST will be measured to evaluate liver function and potential hepatic effects of the intervention. Units: U/L. |
| Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period) |
| Change in Serum Creatinine | Creatinine will be measured to assess renal function during the intervention. Units: mg/dL. | Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period) |
| Change in Serum Urea (BUN) | Blood urea nitrogen will be assessed to monitor renal function. Units: mg/dL. | Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period) |
| Change in Prothrombin Time (PT) | Prothrombin time will be measured to evaluate potential changes in coagulation. Results will be expressed in seconds and percentage (%). | Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period) |
| Change in Hemoglobin Concentration | Hemoglobin levels will be obtained from complete blood count (CBC) as an indicator of hematologic status. Units: g/dL. | Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period) |
| Change in White Blood Cell Count (WBC) | BC count will be analyzed as part of the complete blood count to monitor immune/inflammatory status. Units: numbers of cells x10^3/μL | Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period) |
| Change in Red Blood Cell Count (RBC) | RBC count will be analyzed as part of the complete blood count to monitor hematological status. Units: number of cells ×10^6/μL. | Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period) |
| Gastrointestinal Symptom Frequency | Participants will report gastrointestinal symptoms (e.g., bloating, gas, nausea, diarrhea) using a standardized weekly checklist. Frequency and severity will be described descriptively. | Daily, during each 4-week treatment period. |
| Adherence to Ice Cream Consumption Protocol | Adherence will be assessed by tracking the number of portions consumed compared to the number assigned. Results will be expressed as percentage of compliance. | Throughout each 4-week phase (Week 0 and Week 4 of each treatment period) |
| Product Acceptability and Palatability | Acceptability of the ice cream will be evaluated through a 5-point Likert scale questionnaire covering taste, texture, and overall satisfaction. Results will be analyzed descriptively. | End of each 4-week treatment phase |
| Participant-Reported Adverse Events | Any participant-reported adverse events will be recorded, including type, severity, and possible relationship with the intervention. Events will be categorized by frequency and seriousness. | Continuous, during entire 8-week study period |
| Changes in Platelet Count | Platelet count will be analyzed as part of the complete blood count to monitor hematological status and evaluate potential changes in platelet production or turnover. Units: number of cells ×10^3/μL | Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period) |
| Change in Erythrocyte sedimentation rate (ESR) | Erythrocyte sedimentation rate (ESR) will be analyzed to monitor systemic inflammatory status. Units: mm/hour | Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period) |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |