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Completed

NCT Number: NCT07748559

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

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.

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Key information

Conditions

Insulinemic Response Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperglycaemia (Diabetic) Hyperglycemia Hyperlipidaemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes (Adult Onset)

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pontificia Universidad Javerian

Bogotá, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • o Use of nutritional supplements
  • Uncontrolled chronic diseases (e.g., diabetes, chronic kidney disease)
  • Allergies to palm oil or olive oil

Treatment and study plan

High-oleic palm oil

Other

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

    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).

  2. Changes in Plasma Apolipoprotein B Levels

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

    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.

  3. Changes in the ApoB/LDL-C Atherogenic Index

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

    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.

Sponsors and collaborators

Lead sponsor

Ruby Alejandra Villamil

Other

Collaborators

  • Pontificia Universidad Javeriana

Registry information

Official study title

Effect of Domestic Consumption of High Oleic Palm Oil on Cardiovascular Risk Biomarkers in Adults in Bogotá, DC

Acronym: EDCHOPA-CRB

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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