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

NCT07748559 | Completed

• 1 other identifier: ID 20722
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• Lipid profile

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

  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.

  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

  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

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

• Changes in the ApoB/LDL-C Atherogenic Index

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

Study Arms (2)

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.

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.

Other: High-oleic palm oil

Interventions

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.

Olive Oil Group (AO); Refined High Oleic Palm Oil (APAOr)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ruby Alejandra Villamil: lead
• Pontificia Universidad Javeriana: collaborator

Study Sites (1)

Pontificia Universidad Javerian

Bogotá, Colombia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Hyperlipidemias

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator; Master in Biological Sciences and Ph.D. in Biological Sciences at PUJ-Bogotá.

Model Details: * 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)

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: August 5, 2026
• Study Start: October 22, 2024
• Primary Completion: September 27, 2025
• Study Completion: June 2, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)