Hyperglycaemia (Diabetic), Hyperlipidaemia, Insulinemic Response, Type 2 Diabetes (Adult Onset)
Conditions
Keywords
Cholesterol, Triglycerides, high-density lipoprotein, low-density lipoprotein, fatty acid satured, oleic fatty acid, olive oil, palm oil
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.
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.
Sponsors
Ruby Alejandra Villamil
Pontificia Universidad Javeriana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). |
| Changes in Plasma Apolipoprotein B Levels | 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. |
| Changes in the ApoB/LDL-C Atherogenic Index | 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. |
Countries
Colombia
Outcome results
None listed