Cardiovascular Disease Risk FactorICE-CBE-GLULIPNCT07053267
Acute Postprandial Effects of Functional Ice Cream With Cimarrón Bean Extrudate in Adults
A study testing Funrional Ice Cream in people with Cardiovascular Disease Risk Factor and Insulin Resistance, run by University of Talca at 1 site in Chile.
Trial summary
The goal of this non-randomized clinical trial is to evaluate the acute postprandial metabolic effects of a functional ice cream enriched with Cimarrón bean (Phaseolus vulgaris L. 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 Disease Risk Factor, Insulin Resistance, Overweight (BMI > 25)
- What is being tested?
- Funrional Ice Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- 26 May 2025to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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: Effects of Acute Consumption of Ice Cream Enriched With Cimarron Bean Extruded on Metabolic Responses in Adults: A Non-Randomized Clinical Trial
The goal of this non-randomized clinical trial is to evaluate the acute postprandial metabolic effects of a functional ice cream enriched with Cimarrón bean (Phaseolus vulgaris L. local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor.
The main questions it aims to answer are:
Read more
- Does the functional ice cream reduce postprandial glucose and insulin levels?
- Does it affect postprandial lipid concentrations?
Researchers will compare participants receiving a single dose of the functional ice cream containing 10 g of extrudate per 100 g to placebo version without extrudate, both ice creams are identical in appearance and taste.
Participants will:
- Attend a clinical visit in fasting conditions (10-12 hours).
- Provide baseline blood samples for glucose, insulin, and lipid profile.
- Consume a single 100 g portion of functional or placebo ice cream.
- Provide postprandial blood samples at defined time points.
Read the detailed description
This Study trial is to evaluate the acute postprandial metabolic effects of a functional ice cream with Cimarrón bean (Phaseolus vulgaris L. local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor.
It is a non-randomized, single-blind, parallel-group clinical trial with two arms: intervention (functional ice cream) and control (placebo ice cream). Both products are matched for texture, flavor, and appearance to maintain participant blinding.
Participants arrive at the clinic after a 10-12 hour fast. Baseline blood samples are collected for glucose, insulin, and lipid profile. They then consume one 100 g portion of the assigned ice cream. Blood samples are collected postprandially at 120 minutes to assess changes in glucose, insulin and lipid profile.
The study aims to determine whether the functional ice cream modifies postprandial glycemic and lipemic responses, providing insight into its potential use as a dietary strategy to reduce cardiometabolic risk.
- Conditions
- Cardiovascular Disease Risk Factor, Insulin Resistance, Overweight (BMI > 25), Hyperglycaemia
- Being tested
- Funrional Ice Cream, Placebo Ice Cream
- Keywords
- Phaseolus vulgaris, Ice cream, Postprandial metabolism, Functional food, Dietary intervention, Glucose response, Insulin response, Lipid profile
- Medical subject headings
- Insulin Resistance, Overweight, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Funrional Ice CreamDietary supplement
Single 100 g serving of ice cream enriched with 10 g of Cimarrón bean extrudate, administered after an overnight fast to evaluate postprandial metabolic responses.
Placebo Ice CreamDietary supplement
Single 100 g serving of placebo ice cream identical in flavor, texture, and appearance, but without Cimarrón bean extrudate, administered after an overnight fast to evaluate postprandial metabolic responses.
| Study group | Role | What they receive |
|---|---|---|
| Functional Ice Cream with Cimarrón Bean Extrudate | Experimental | Participants consume a single 100 g portion of ice cream enriched with 10 g Cimarrón bean extrudate. Receives: Dietary Supplement: Funrional Ice Cream |
| Placebo Ice Cream | Placebo comparator | Participants consume a single 100 g portion of placebo ice cream identical in appearance and flavor, but without the Cimarrón bean extrudate. Receives: Dietary Supplement: Placebo Ice Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Postprandial Glucose Concentration
Blood glucose levels will be measured at fasting (baseline) and at 120 minutes following the intake of either functional or placebo ice cream. Outcome will be expressed in mg/dL.
Measured: Baseline and 120 minutes after consumption
Change in Postprandial Insulin Concentration
Blood insulin levels will be assessed at fasting and at 120 minutes post-consumption. Outcome will be expressed in µIU/mL.
Measured: Baseline and 120 minutes after consumption
Secondary outcomes (1)
Change in Postprandial Lipid Profile
Total cholesterol, HDL-c, LDL-c, and triglycerides will be measured at baseline and at 120 minutes post-consumption. Values will be expressed in mg/dL.
Measured: Baseline and 120 minutes after consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start26 May 2025
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease Risk FactorStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group clinical trial in which participants were non-randomly assigned to one of two arms: a single-dose intervention group consuming a functional ice cream enriched with Cimarrón bean extrudate, or a placebo group consuming an identical ice cream without the functional ingredient. Both groups were assessed in parallel for postprandial metabolic responses after a single intervention day.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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
- NCT07053267
- Sponsor's protocol ID
- ACU-HEP-UTALCA-F29-2021
- Acronym
- ICE-CBE-GLULIP
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 8 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 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Consumption of Ice Cream Enriched With Cimarron Bean Extruded on Metabolic Responses in Adults: A Non-Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07053267
- Acronym / sponsor ID
- ICE-CBE-GLULIP / ACU-HEP-UTALCA-F29-2021
- Conditions
- Cardiovascular Disease Risk Factor, Insulin Resistance, Overweight (BMI > 25), Hyperglycaemia
- Keywords
- Phaseolus vulgaris, Ice cream, Postprandial metabolism, Functional food, Dietary intervention, Glucose response, Insulin response, Lipid profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 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
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 8 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 non-randomized clinical trial is to evaluate the acute postprandial metabolic effects of a functional ice cream enriched with Cimarrón bean (Phaseolus vulgaris L. local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor.
The main questions it aims to answer are:
- Does the functional ice cream reduce postprandial glucose and insulin levels?
- Does it affect postprandial lipid concentrations?
Researchers will compare participants receiving a single dose of the functional ice cream containing 10 g of extrudate per 100 g to placebo version without extrudate, both ice creams are identical in appearance and taste.
Participants will:
- Attend a clinical visit in fasting conditions (10-12 hours).
- Provide baseline blood samples for glucose, insulin, and lipid profile.
- Consume a single 100 g portion of functional or placebo ice cream.
- Provide postprandial blood samples at defined time points.
Detailed description
This Study trial is to evaluate the acute postprandial metabolic effects of a functional ice cream with Cimarrón bean (Phaseolus vulgaris L. local variety Cimarrón) extrudate in adults with at least one cardiovascular risk factor.
It is a non-randomized, single-blind, parallel-group clinical trial with two arms: intervention (functional ice cream) and control (placebo ice cream). Both products are matched for texture, flavor, and appearance to maintain participant blinding.
Participants arrive at the clinic after a 10-12 hour fast. Baseline blood samples are collected for glucose, insulin, and lipid profile. They then consume one 100 g portion of the assigned ice cream. Blood samples are collected postprandially at 120 minutes to assess changes in glucose, insulin and lipid profile.
The study aims to determine whether the functional ice cream modifies postprandial glycemic and lipemic responses, providing insight into its potential use as a dietary strategy to reduce cardiometabolic risk.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a parallel-group clinical trial in which participants were non-randomly assigned to one of two arms: a single-dose intervention group consuming a functional ice cream enriched with Cimarrón bean extrudate, or a placebo group consuming an identical ice cream without the functional ingredient. Both groups were assessed in parallel for postprandial metabolic responses after a single intervention day.
| Arm | Type | Receives |
|---|---|---|
| Functional Ice Cream with Cimarrón Bean Extrudate | Experimental | Dietary Supplement: Funrional Ice CreamParticipants consume a single 100 g portion of ice cream enriched with 10 g Cimarrón bean extrudate. |
| Placebo Ice Cream | Placebo comparator | Dietary Supplement: Placebo Ice CreamParticipants consume a single 100 g portion of placebo ice cream identical in appearance and flavor, but without the Cimarrón bean extrudate. |
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 |
|---|---|---|
| Funrional Ice CreamSingle 100 g serving of ice cream enriched with 10 g of Cimarrón bean extrudate, administered after an overnight fast to evaluate postprandial metabolic responses. | Dietary supplement | Functional Ice Cream with Cimarrón Bean Extrudate |
| Placebo Ice CreamSingle 100 g serving of placebo ice cream identical in flavor, texture, and appearance, but without Cimarrón bean extrudate, administered after an overnight fast to evaluate postprandial metabolic responses. | Dietary supplement | Placebo Ice Cream |
Primary outcome
Change in Postprandial Glucose Concentration
Time frame: Baseline and 120 minutes after consumption
Blood glucose levels will be measured at fasting (baseline) and at 120 minutes following the intake of either functional or placebo ice cream. Outcome will be expressed in mg/dL.
Change in Postprandial Insulin Concentration
Time frame: Baseline and 120 minutes after consumption
Blood insulin levels will be assessed at fasting and at 120 minutes post-consumption. Outcome will be expressed in µIU/mL.
1 secondary outcome
Change in Postprandial Lipid Profile
Time frame: Baseline and 120 minutes after consumption.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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.
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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 Funrional Ice Cream in people with Cardiovascular Disease Risk Factor 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: finished, as of the sponsor's last update on 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Postprandial Glucose Concentration (time frame: Baseline and 120 minutes after consumption). 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 8 Jul 2025.