Postprandial GlucoseCBE-SPNCT07043829
Cimarrón Bean Extrudate Solution on Platelet Function and Biochemical Parameters
A study testing SPVCE (Solution Phaseolus vulgaris L. var. Cimarrón Extrudate in Water) in people with Postprandial Glucose and Platelet Activation, run by University of Talca at 1 site in Chile.
Trial summary
This non-randomized acute clinical trial evaluates the effect of consuming a water-based solution of Cimarrón bean extrudate on platelet function and postprandial glycemia in adults. Participants will consume a single 10-gram dose of Cimarrón bean extrudate dissolved in water. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glucose, Platelet Activation
- What is being tested?
- SPVCE (Solution Phaseolus vulgaris L. var. Cimarrón Extrudate in Water)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 13 Mar 2025to 19 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 informend consent
Who cannot join
- Documented food allergies, especially ti legumes or beans
- Diagnosed liver, kidney, , autoinmune 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
- Use medication known to alter platelet funtion like, antiplatelet agents (aspirin, clopidogrel); Non-steroidal anti-inflamatory drugs (NSAID-Ibuprofen, naproxen); Anticoagulants (Warfarin, heparin, direct oral anticoagulant like rivaroxaban or apixaban); Selective serotonin reuptake inhibitors (SSRIs) and other drugs known to impact platelet aggregation or hemostasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Consuming a Cimarrón Bean Extrudate Solution on Platelet Function and Postprandial Biochemical Parameters
This non-randomized acute clinical trial evaluates the effect of consuming a water-based solution of Cimarrón bean extrudate on platelet function and postprandial glycemia in adults.
Participants will consume a single 10-gram dose of Cimarrón bean extrudate dissolved in water. Blood samples will be collected before and after the intervention to assess platelet reactivity using flow cytometry and to measure glucose levels through colorimetric spectrophotometry. The total intervention period will last approximately 8 hours. This study aims to explore whether the acute consumption of this legume-based functional product can influence hemostatic and glycemic responses in the postprandial state.
Read the detailed description
This clinical trial aims to evaluate the acute effects of consuming a beverage made from Cimarrón bean extrudate on platelet function and postprandial blood glucose levels in adult participants. The study involves a single-arm, non-randomized, open-label design in which each participant will consume a single oral dose of 10 grams of Cimarrón bean extrudate dissolved in water (SPVCE: Solution Phaseolus vulgaris L var. Cimarrón extrudate)
The trial includes baseline and post-intervention assessments of platelet reactivity using flow cytometry, employing specific agonists (CRP, TRAP, ADP) and labeled antibodies (anti-fibrinogen FITC, PE-CD61/CD62). Blood glucose levels will also be measured at multiple time points using colorimetric spectrophotometry to evaluate postprandial metabolic response.
The total study duration per participant is approximately 8 hours, including fasting baseline measurements, administration of the intervention, and postprandial monitoring. This study seeks to provide preliminary data on the potential hemostatic and glycemic effects of a legume-derived functional food ingredient in a controlled, acute setting.
- Conditions
- Postprandial Glucose, Platelet Activation
- Being tested
- SPVCE (Solution Phaseolus vulgaris L. var. Cimarrón Extrudate in Water)
- Keywords
- Phaseolus vulgaris, Platelet reactivity, Funtional food, Legume-base food, Platelet activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPVCE (Solution Phaseolus vulgaris L. var. Cimarrón Extrudate in Water)Dietary supplement
Also called SAEP (Solution of Cimarrón Bean Extrudate in Water)
A single oral dose of 10 grams of Cimarrón bean (Phaseolus vulgaris L., variety Cimarrón) extrudate dissolved in 500 mL of water, consumed once under fasting conditions, to evaluate acute effects on platelet function (reactivity and blood risk), postprandial glycemia, and total polyphenol concentration at baseline (0 hours), 2 hours, and 6 hours after SPVCE consumption.
| Study group | Role | What they receive |
|---|---|---|
| SPVCE Intervention | Experimental | Participants will receive a single oral dose of 10 grams of SPVCE. Platelet function (Reactivity and blood risk), postprandial glycemia and Polyphenol concentration will be measured before and after the intervention. Receives: Dietary Supplement: SPVCE (Solution Phaseolus vulgaris L. var. Cimarrón Extrudate in Water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Platelet Reactivity After Acute Consumption of SPVCE
The platelet reactivity was assessed in response to three agonists: ADP, CRP, and TRAP-6. The expression changes of P-selectin and the binding of Fibrinogen to the platelet were measured at baseline (0 hours) and 6 hours. The data were analyzed using dose-response curves and derived metrics of these curves, including basal activity (minimum), maximal response (maximum), EC50, and Capacity of response as the difference between the maximal response and the basal state.
Measured: Baseline (0 hours) and 6 hours post-intervention
Secondary outcomes (3)
Change in Postprandial Blood Glucose Levels After Consumption of SPVCE
Blood glucose concentrations will be measured at baseline and postprandial time, 2 hours after consuming 10 g SPVCE. The aim is to evaluate the glycemic response and potential glycemia-lowering effects of the intervention.
Measured: Baseline and up to 2 hours post-intervention
Change in Postprandial Plasma Concentration of Total Polyphenols After Consumption of SPVCE
This outcome assesses the effect of consuming SPVCE on plasma concentrations of total polyphenols. Samples were analyzed using validated spectrophotometric methods.
Unit of measure: mg GAE/uL plasma.
Measured: 0 minutes (baseline) 2 hour and 6 hours postprandial.
Change in Postprandial Platelet Function (Closure Time) After Consumption of SPVCE
Platelet function will be evaluated using the PFA-200 system with collagen/ADP (Col/ADP) cartridges. Closure time (in seconds) reflects platelet aggregation under high shear conditions. Measurements will be performed at baseline (0 hours) and 6 hour after consumption of SPVCE.
Measured: Baseline (0 hours) and 6 hour post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start13 Mar 2025
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postprandial GlucoseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single-group, open-label clinical trial in which all participants receive a single dose of a functional beverage containing 10 grams of Cimarrón bean extrudate dissolved in water. No placebo or comparator group is included. Outcomes are measured before and after the intervention within the same participants to assess acute changes in platelet function and postprandial glycemia.
- Masking
- None (open label)
- Enrolment
- 30 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 Gonzalez, PhD. Biomedical Science, Principal investigator, University of TalcaEduardo J Fuentes Quinteros, PhD. Science research, Study chair, University of Talca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043829
- Sponsor's protocol ID
- PCSAEPF29-2021
- Acronym
- CBE-SP
- Status last verified
- Dec 2025
- First submitted
- 20 Jun 2025
- Last updated
- 9 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. As stated in the informed consent, participation is strictly confidential; participant names and identifiers are not used. Blood samples are coded and not linked to personal data. Identity and health information will not be disclosed or shared outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consuming a Cimarrón Bean Extrudate Solution on Platelet Function and Postprandial Biochemical Parameters
- ClinicalTrials.gov ID
- NCT07043829
- Acronym / sponsor ID
- CBE-SP / PCSAEPF29-2021
- Conditions
- Postprandial Glucose, Platelet Activation
- Keywords
- Phaseolus vulgaris, Platelet reactivity, Funtional food, Legume-base food, Platelet activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of TalcaUniversity, hospital or other
- Collaborators
- Centro de Estudios en Alimentos Procesados
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Posted 9 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This non-randomized acute clinical trial evaluates the effect of consuming a water-based solution of Cimarrón bean extrudate on platelet function and postprandial glycemia in adults.
Participants will consume a single 10-gram dose of Cimarrón bean extrudate dissolved in water. Blood samples will be collected before and after the intervention to assess platelet reactivity using flow cytometry and to measure glucose levels through colorimetric spectrophotometry. The total intervention period will last approximately 8 hours. This study aims to explore whether the acute consumption of this legume-based functional product can influence hemostatic and glycemic responses in the postprandial state.
Detailed description
This clinical trial aims to evaluate the acute effects of consuming a beverage made from Cimarrón bean extrudate on platelet function and postprandial blood glucose levels in adult participants. The study involves a single-arm, non-randomized, open-label design in which each participant will consume a single oral dose of 10 grams of Cimarrón bean extrudate dissolved in water (SPVCE: Solution Phaseolus vulgaris L var. Cimarrón extrudate)
The trial includes baseline and post-intervention assessments of platelet reactivity using flow cytometry, employing specific agonists (CRP, TRAP, ADP) and labeled antibodies (anti-fibrinogen FITC, PE-CD61/CD62). Blood glucose levels will also be measured at multiple time points using colorimetric spectrophotometry to evaluate postprandial metabolic response.
The total study duration per participant is approximately 8 hours, including fasting baseline measurements, administration of the intervention, and postprandial monitoring. This study seeks to provide preliminary data on the potential hemostatic and glycemic effects of a legume-derived functional food ingredient in a controlled, acute setting.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-group, open-label clinical trial in which all participants receive a single dose of a functional beverage containing 10 grams of Cimarrón bean extrudate dissolved in water. No placebo or comparator group is included. Outcomes are measured before and after the intervention within the same participants to assess acute changes in platelet function and postprandial glycemia.
| Arm | Type | Receives |
|---|---|---|
| SPVCE Intervention | Experimental | Dietary Supplement: SPVCE (Solution Phaseolus vulgaris L. var. Cimarrón Extrudate in Water)Participants will receive a single oral dose of 10 grams of SPVCE. Platelet function (Reactivity and blood risk), postprandial glycemia and Polyphenol concentration will be measured before and after the intervention. |
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 informend consent
Key exclusion criteria (4 listed)
- Documented food allergies, especially ti legumes or beans
- Diagnosed liver, kidney, , autoinmune 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
- Use medication known to alter platelet funtion like, antiplatelet agents (aspirin, clopidogrel); Non-steroidal anti-inflamatory drugs (NSAID-Ibuprofen, naproxen); Anticoagulants (Warfarin, heparin, direct oral anticoagulant like rivaroxaban or apixaban); Selective serotonin reuptake inhibitors (SSRIs) and other drugs known to impact platelet aggregation or hemostasis.
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 |
|---|---|---|
| SPVCE (Solution Phaseolus vulgaris L. var. Cimarrón Extrudate in Water)Also: SAEP (Solution of Cimarrón Bean Extrudate in Water)A single oral dose of 10 grams of Cimarrón bean (Phaseolus vulgaris L., variety Cimarrón) extrudate dissolved in 500 mL of water, consumed once under fasting conditions, to evaluate acute effects on platelet function (reactivity and blood risk), postprandial glycemia, and total polyphenol concentration at baseline (0 hours), 2 hours, and 6 hours after SPVCE consumption. | Dietary supplement | SPVCE Intervention |
Primary outcome
Change in Platelet Reactivity After Acute Consumption of SPVCE
Time frame: Baseline (0 hours) and 6 hours post-intervention
The platelet reactivity was assessed in response to three agonists: ADP, CRP, and TRAP-6. The expression changes of P-selectin and the binding of Fibrinogen to the platelet were measured at baseline (0 hours) and 6 hours. The data were analyzed using dose-response curves and derived metrics of these curves, including basal activity (minimum), maximal response (maximum), EC50, and Capacity of response as the difference between the maximal response and the basal state.
3 secondary outcomes
Change in Postprandial Blood Glucose Levels After Consumption of SPVCE
Time frame: Baseline and up to 2 hours post-intervention
Change in Postprandial Plasma Concentration of Total Polyphenols After Consumption of SPVCE
Time frame: 0 minutes (baseline) 2 hour and 6 hours postprandial.
Change in Postprandial Platelet Function (Closure Time) After Consumption of SPVCE
Time frame: Baseline (0 hours) and 6 hour post-intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. As stated in the informed consent, participation is strictly confidential; participant names and identifiers are not used. Blood samples are coded and not linked to personal data. Identity and health information will not be disclosed or shared outside the study team.
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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 Gonzalez, PhD. Biomedical Science principal investigator
University of Talca
Eduardo J Fuentes Quinteros, PhD. Science research study chair
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 SPVCE (Solution Phaseolus vulgaris L. var. Cimarrón Extrudate in Water) in people with Postprandial Glucose and Platelet Activation, 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 4 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 9 Apr 2026. 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. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Platelet Reactivity After Acute Consumption of SPVCE (time frame: Baseline (0 hours) and 6 hours post-intervention). 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 9 Apr 2026.