Cardiovascular Risk FactorsICE-CBE-CARDNCT07076563
Ice Cream Enriched With Cimarrón Bean Extrudate and Cardiovascular Risk in Adults
A study testing Functional Ice Cream with Cimarrón Bean Extrudate in people with Cardiovascular Risk Factors and Insulin Resistance, run by University of Talca at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors, Insulin Resistance, Overweight (BMI > 25)
- What is being tested?
- Functional Ice Cream with Cimarrón Bean Extrudate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChile
- Study dates
- 26 May 2025to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary participant
- Men and women aged 20-59 years
- Willingness to participate and provide written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Effects of Ice Cream Enriched With Cimarrón Bean Extrudate on Metabolic and Cardiovascular Risk Markers: A Randomized Crossover Clinical Trial in Adults
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:
Read more
- 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)
Read the detailed description
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).
- Being tested
- Functional Ice Cream with Cimarrón Bean Extrudate, Placebo Ice Cream
- Keywords
- Phaseolus vulgaris, Funtional food, Legume-base food, cardiovascular disease, cardiovascular risk
- Medical subject headings
- Insulin Resistance, Overweight, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Ice Cream with Cimarrón Bean ExtrudateDietary 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 CreamDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Placebo Ice Cream |
| 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. Receives: Dietary Supplement: Functional Ice Cream with Cimarrón Bean Extrudate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start26 May 2025
- Primary completion5 Sep 2025 (estimated)
- Study completion5 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Talca
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Estudios en Alimentos Procesados
- Responsible party
- Principal investigator, Iván Palomo González, University of Talca
- Investigators
- Ivan F Palomo González, PhD. Biomedical Science, Principal investigator, University of TalcaEduardo J Fuentes Quinteros, PhD. Science research, Principal investigator, University of Talca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076563
- Sponsor's protocol ID
- CH-HEP-UTALCA-F29-2021
- Acronym
- ICE-CBE-CARD
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effects of Ice Cream Enriched With Cimarrón Bean Extrudate on Metabolic and Cardiovascular Risk Markers: A Randomized Crossover Clinical Trial in Adults
- ClinicalTrials.gov ID
- NCT07076563
- Acronym / sponsor ID
- ICE-CBE-CARD / CH-HEP-UTALCA-F29-2021
- Keywords
- Phaseolus vulgaris, Funtional food, Legume-base food, cardiovascular disease, cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of TalcaUniversity, hospital or other
- Collaborators
- Centro de Estudios en Alimentos Procesados
- Study start
- 26 May 2025 (actual)
- Primary completion
- 5 Sep 2025 (estimated)
- Study completion
- 5 Sep 2025 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Placebo Ice Cream | Placebo comparator | Dietary Supplement: Placebo Ice CreamParticipants 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. |
| Functional Ice Cream Enriched with Cimarrón Bean Extrudate | Experimental | Dietary Supplement: Functional Ice Cream with Cimarrón Bean ExtrudateParticipants 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. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Voluntary participant
- Men and women aged 20-59 years
- Willingness to participate and provide written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Ice Cream with Cimarrón Bean ExtrudateIce 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. | Dietary supplement | Functional Ice Cream Enriched with Cimarrón Bean Extrudate |
| Placebo Ice CreamIce 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. | Dietary supplement | Placebo Ice Cream |
Primary outcome
Change in Serum Glucose
Time frame: Baseline 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 Insulin
Time frame: Baseline 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.
10 secondary outcomes
Change in Total Cholesterol
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Change in Triglycerides
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)
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)
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
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Change in Waist Circumference
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)
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Change in Body Weight
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)
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Change in Arm Circumference
Time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: Undecided. 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
Related trials for Cardiovascular Risk Factors
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Enrolling by invitation
Nutrition in Rheumatoid Arthritis
Rheumatoid Arthritis (RA)
Active, not recruitingObservational study
Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images
Diabetic Retinopathy, Diabetic Macular Edema
RecruitingObservational study
Reliability of Multiple-Repetition-Maximum Tests in Patients With Cardiovascular Disease or Risk Factors
Heart Failure, Coronary Heart Disease (CHD)
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan F Palomo González, PhD. Biomedical Science principal investigator
University of Talca
Eduardo J Fuentes Quinteros, PhD. Science research principal investigator
University of Talca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Ice Cream with Cimarrón Bean Extrudate in people with Cardiovascular Risk Factors and Insulin Resistance, run by University of Talca at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Glucose (time frame: Baseline and end of each 4-week phase (Week 0 and Week 4 of each treatment period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.