Health Effects of Consuming Olive Pomace Oil
- Conditions
- HealthyHypercholesterolemia
- Registration Number
- NCT04998695
- Lead Sponsor
- Instituto de Ciencia y Tecnología de Alimentos y Nutrición
- Brief Summary
Healthy and at risk (hypercholesterolemic) subjects consumed during 4 weeks 45 g/d of either olive pomace oil (OPO) or sunflower oil (SO) as the only dietary fat in a randomized, crossover trial. The effects on blood lipids, glucose homeostasis, endothelial function, inflammatory cytokines, oxidative stress biomarkers and anthropometry were measured.
- Detailed Description
The intervention aimed at studying the potential health effects of olive pomace oil in comparison with sunflower oil.
After a 3-weeks run-in, 31 healthy (normocholesterolemic) and 37 hypercholesterolemic subjects were randomized to consume either OPO or SO (45 g/d) during 4 weeks, followed by a 3-week wash-out during which volunteers consumed the same amount of corn oil. During all the study, other dietary sources of fat (oil, nuts, butter, etc.) were restricted. Food intake was monitored by 3-d food records in each intervention stage and volunteers were instructed to maintain their normal physical and dietary habits (except for the changes in the consumption of other oils and fats).
At the beginning and end of each intervention stage, blood and urine samples were obtained, and blood pressure and anthropometric measurements were performed. A complete batch of analysis were performed, including serum lipids, endothelial function (endothelial nitric oxide synthase (eNOS), vascular (VCAM-1) and intercellular (ICAM-1) cell adhesion molecules, E- and P-selectins), inflammatory and anti-inflammatory cytokines, glucose homeostasis/insulin resistance, antioxidant status and biomarkers of lipid oxidation (malondialdehyde (MDA), LDLox, ferric reducing antioxidant power (FRAP), oxygen radical absorbance capacity (ORAC), ABTS (2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) quenching capacity) and anthropometry, along with determination of incretins, adipokines, and other clinical and hematological parameters.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- Healthy volunteers (Total cholesterol < 200 mg/dL; LDL-cholesterol < 135 mg/dL)
- Hypercholesterolemic volunteers (Total cholesterol 200-300 mg/dL; LDL-cholesterol 135-175 mg/dL)
- BMI > 30 Kg/m2
- Smokers
- Vegetarians
- Pregnant women
- Medication/consumption of vitamins, dietary supplements
- On antibiotic treatment 3 months before starting the study
- Digestive disorders/pathologies (gastric ulcer, Chron's disease, inflammatory bowel syndrome, etc.)
- Food allergies/intolerances
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Blood lipids 4 weeks Reduction of total or LDL-cholesterol levels or triglycerides in at risk (hypercholesterolemic) subjects. No effect on blood lipids expected in healthy (normocholesterolemic) volunteers
- Secondary Outcome Measures
Name Time Method Endothelial function 4 weeks Modification in the levels of selectins, adhesion molecules, or eNOS levels in volunteers
Blood pressure 4 weeks Changes in systolic/diastolic blood pressure in volunteers
Glucose homeostasis 4 weeks Modification of fasting blood glucose or insulin levels, decrease in glycosylated hemoglobin (Hb1Ac), homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) or beta-cell function (HOMA-beta)
Inflammation 4 weeks Concentration of serum pro-inflammatory cytokines/C-Reactive protein (CRP) modified in participants
Oxidative status 4 weeks Modification of serum antioxidant capacity (FRAP, ABTS, ORAC, expressed as nM Trolox equivalents)
Lipid oxidation markers 4 weeks Concentration of biomarkers of lipid oxidation (MDA and/or LDLox) in serum modified
Trial Locations
- Locations (1)
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
🇪🇸Madrid, Spain
Instituto de Ciencia y Tecnología de Alimentos y Nutrición🇪🇸Madrid, Spain