Insulinemic ResponseEDCHOPA-CRBNCT07748559
Impact of High-Oleic Palm Oil Consumption on Cardiovascular Biomarkers in Adults in Bogotá
A study testing High-oleic palm oil in people with Insulinemic Response and Type 2 Diabetes (Adult Onset), run by Ruby Alejandra Villamil at 1 site in Colombia.
Trial summary
This randomized clinical trial aims to evaluate the effects of refined high-oleic palm oil consumption on cardiovascular risk biomarkers and insulin resistance in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Insulinemic Response, Type 2 Diabetes (Adult Onset), Hyperglycaemia (Diabetic)
- What is being tested?
- High-oleic palm oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteColombia
- Study dates
- 22 Oct 2024to 2 Jun 2026
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged ≥18 years
- Stable medication dosages (if applicable)
- Signed informed consent
Who cannot join
- o Use of nutritional supplements
- Uncontrolled chronic diseases (e.g., diabetes, chronic kidney disease)
- Allergies to palm oil or olive oil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Domestic Consumption of High Oleic Palm Oil on Cardiovascular Risk Biomarkers in Adults in Bogotá, DC
This randomized clinical trial aims to evaluate the effects of refined high-oleic palm oil consumption on cardiovascular risk biomarkers and insulin resistance in healthy adults. Participants will be randomly assigned to two groups to consume either high-oleic palm oil or olive oil for four months in typical domestic preparations.
- Conditions
- Insulinemic Response, Type 2 Diabetes (Adult Onset), Hyperglycaemia (Diabetic), Hyperlipidaemia
- Being tested
- High-oleic palm oil
- Keywords
- Cholesterol, Triglycerides, high-density lipoprotein, low-density lipoprotein, fatty acid satured, oleic fatty acid, olive oil, palm oil
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-oleic palm oilOther
These findings are expected to confirm the hypothesis that refined high-oleic palm oil offers similar health benefits to extra virgin olive oil, particularly in terms of lipid profile and erythrocyte membrane fatty acid composition. The anticipated results aim to provide robust scientific evidence promoting refined high-oleic palm oil as a healthier alternative for domestic cooking, reinforcing its potential role in cardiovascular health management.
| Study group | Role | What they receive |
|---|---|---|
| Refined High Oleic Palm Oil (APAOr) | Experimental | Twenty-six participants were assigned to receive refined high oleic palm oil (APAOr) as the exclusive edible cooking oil for household food preparation. Participants received approximately 1.5 L of oil per month and were instructed to use only the assigned oil during the 4-month intervention period. Receives: Other: High-oleic palm oil |
| Olive Oil Group (AO) | Active comparator | Twenty participants were assigned to receive olive oil (AO) as the exclusive edible cooking oil for household food preparation. Participants received approximately 1.5 L of oil per month and were instructed to use only the assigned oil during the 4-month intervention period. Receives: Other: High-oleic palm oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
Plasma levels of cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, and apolipoprotein B
Measured: From the start of the intervention until the last data point is 4 months. Biochemical laboratory tests are performed every two months, meaning a total of three data points will be collected (initial, intermediate, and final).
Changes in Biomarkers of Glycemic Control and Insulin Resistance
To evaluate the effect of high-oleic palm oil consumption compared to olive oil on fasting glucose, glycated hemoglobin (HbA1c), fasting insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR index), and triglyceride-glucose (TyG) index as indicators of metabolic control and insulin sensitivity.
Measured: Duration of the intervention: four months, with three laboratory analyses: baseline analysis at 0 month, mid-term analysis at two months, and final analysis at four months.
Secondary outcomes (3)
Liver function
Monitoring variables to ensure that the oils do not alter liver function: Alkaline phosphatase, Aspartate aminotransferase (AST), Alkaline glutamic-pyruvic transaminase (ALT), Gamma-glutamyl transferase (GGT).
Measured: Intervention duration: four months, with three laboratory tests: initial test at month zero, intermediate test at two months, and final test at four months.
Changes in Plasma Apolipoprotein B Levels
To determine the effect of high-oleic palm oil consumption compared to olive oil on serum concentrations of apolipoprotein B (ApoB), considered a biomarker of atherogenic cardiovascular risk and an indicator of the amount of circulating atherogenic particles.
Measured: 4 months: Baseline (Month 0), Month 2, and Month 4 of intervention.
Changes in the ApoB/LDL-C Atherogenic Index
To evaluate the effect of high-oleic palm oil consumption compared to olive oil on the ApoB/LDL-C ratio, used as an indirect indicator of the number of atherogenic LDL particles and residual cardiovascular risk.
Measured: Intervention 4 months: Baseline (Month 0), Month 2, and Month 4 of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start22 Oct 2024
- Primary completion27 Sep 2025
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulinemic ResponseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Group 1 (Experimental): High-oleic palm oil (1,5 liter/month for 4 months) * Group 2 (Active Comparator): Olive oil (1,5 liter/month for 4 months)
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruby Alejandra Villamil
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Responsible party
- Sponsor-investigator, Ruby Alejandra Villamil, Pontificia Universidad Javeriana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748559
- Sponsor's protocol ID
- ID 20722
- Other IDs
- ID 20722
- Acronym
- EDCHOPA-CRB
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Domestic Consumption of High Oleic Palm Oil on Cardiovascular Risk Biomarkers in Adults in Bogotá, DC
- ClinicalTrials.gov ID
- NCT07748559
- Acronym / sponsor ID
- EDCHOPA-CRB / ID 20722
- Conditions
- Insulinemic Response, Type 2 Diabetes (Adult Onset), Hyperglycaemia (Diabetic), Hyperlipidaemia
- Keywords
- Cholesterol, Triglycerides, high-density lipoprotein, low-density lipoprotein, fatty acid satured, oleic fatty acid, olive oil, palm oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ruby Alejandra VillamilUniversity, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 27 Sep 2025 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 5 Aug 2026 (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.
This randomized clinical trial aims to evaluate the effects of refined high-oleic palm oil consumption on cardiovascular risk biomarkers and insulin resistance in healthy adults. Participants will be randomly assigned to two groups to consume either high-oleic palm oil or olive oil for four months in typical domestic preparations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Group 1 (Experimental): High-oleic palm oil (1,5 liter/month for 4 months) * Group 2 (Active Comparator): Olive oil (1,5 liter/month for 4 months)
| Arm | Type | Receives |
|---|---|---|
| Refined High Oleic Palm Oil (APAOr) | Experimental | Other: High-oleic palm oilTwenty-six participants were assigned to receive refined high oleic palm oil (APAOr) as the exclusive edible cooking oil for household food preparation. Participants received approximately 1.5 L of oil per month and were instructed to use only the assigned oil during the 4-month intervention period. |
| Olive Oil Group (AO) | Active comparator | Other: High-oleic palm oilTwenty participants were assigned to receive olive oil (AO) as the exclusive edible cooking oil for household food preparation. Participants received approximately 1.5 L of oil per month and were instructed to use only the assigned oil during the 4-month intervention period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged ≥18 years
- Stable medication dosages (if applicable)
- Signed informed consent
Key exclusion criteria (3 listed)
- o Use of nutritional supplements
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 |
|---|---|---|
| High-oleic palm oilThese findings are expected to confirm the hypothesis that refined high-oleic palm oil offers similar health benefits to extra virgin olive oil, particularly in terms of lipid profile and erythrocyte membrane fatty acid composition. The anticipated results aim to provide robust scientific evidence promoting refined high-oleic palm oil as a healthier alternative for domestic cooking, reinforcing its potential role in cardiovascular health management. | Other | Olive Oil Group (AO), Refined High Oleic Palm Oil (APAOr) |
Primary outcome
Lipid profile
Time frame: From the start of the intervention until the last data point is 4 months. Biochemical laboratory tests are performed every two months, meaning a total of three data points will be collected (initial, intermediate, and final).
Plasma levels of cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, and apolipoprotein B
Changes in Biomarkers of Glycemic Control and Insulin Resistance
Time frame: Duration of the intervention: four months, with three laboratory analyses: baseline analysis at 0 month, mid-term analysis at two months, and final analysis at four months.
To evaluate the effect of high-oleic palm oil consumption compared to olive oil on fasting glucose, glycated hemoglobin (HbA1c), fasting insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR index), and triglyceride-glucose (TyG) index as indicators of metabolic control and insulin sensitivity.
3 secondary outcomes
Liver function
Time frame: Intervention duration: four months, with three laboratory tests: initial test at month zero, intermediate test at two months, and final test at four months.
Changes in Plasma Apolipoprotein B Levels
Time frame: 4 months: Baseline (Month 0), Month 2, and Month 4 of intervention.
Changes in the ApoB/LDL-C Atherogenic Index
Time frame: Intervention 4 months: Baseline (Month 0), Month 2, and Month 4 of intervention.
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 5 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-oleic palm oil in people with Insulinemic Response and Type 2 Diabetes (Adult Onset), run by Ruby Alejandra Villamil at 1 site in Colombia.
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 5 Aug 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 Colombia. 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?
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?
Lipid profile (time frame: From the start of the intervention until the last data point is 4 months. Biochemical laboratory tests are performed every two months, meaning a total of three data points will be collected (initial, intermediate, and final).). 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 5 Aug 2026.