CClinicalTrials.gg
CompletedNCT07748559EDCHOPA-CRBUpdated Aug 5, 2026

Impact of High-Oleic Palm Oil Consumption on Cardiovascular Biomarkers in Adults in Bogotá

An interventional study of High-oleic palm oil in Insulinemic Response, Type 2 Diabetes (Adult Onset) and Hyperglycaemia (Diabetic), sponsored by Ruby Alejandra Villamil. Completed at 1 site in Colombia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Ruby Alejandra Villamil · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Oct 2024, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • 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
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 52 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

This is the only study on the registry with Ruby Alejandra Villamil as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults aged ≥18 years
  • Stable medication dosages (if applicable)
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • o Use of nutritional supplements

    • Uncontrolled chronic diseases (e.g., diabetes, chronic kidney disease)
    • Allergies to palm oil or olive oil
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Refined High Oleic Palm Oil (APAOr)

    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.

    Other: High-oleic palm oil

  • Active comparator
    Olive Oil Group (AO)

    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.

    Other: High-oleic palm oil

Interventions

  • OtherHigh-oleic palm oil

    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.

06

What researchers measure

Primary outcomes

  1. Lipid profile

    Plasma levels of cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, and apolipoprotein B

    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).

  2. 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.

    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.

Secondary outcomes

  1. 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).

    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.

  2. 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.

    Time frame: 4 months: Baseline (Month 0), Month 2, and Month 4 of intervention.

  3. 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.

    Time frame: Intervention 4 months: Baseline (Month 0), Month 2, and Month 4 of intervention.

07

Study locations

1 site
  • Pontificia Universidad Javerian
    Bogotá, Colombia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07748559
Lead sponsor
Ruby Alejandra Villamil
Collaborators
Pontificia Universidad Javeriana
Responsible party
Ruby Alejandra Villamil (Principal Investigator; Master in Biological Sciences and Ph.D. in Biological Sciences at PUJ-Bogotá., Pontificia Universidad Javeriana) — Sponsor-investigator
First posted
Aug 5, 2026
Start date
Oct 22, 2024
Primary completion
Sep 27, 2025
Completion
Jun 2, 2026
Last update
Aug 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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