Health Effects of Consuming Olive Pomace Oil

Study Overview
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Brief Summary
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Healthy and at risk (hypercholesterolemic) subjects consumed during 4 weeks 45 g/d of either olive pomace oil (OPO) or high oleic acid sunflower oil (HOSO) 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
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This is the first study on the potential health effects of consumption of olive pomace oil. After a 3-weeks run-in, 34 healthy and 30 hypercholesterolemic subjects were randomized to consume either OPO or HOSO (45 g/d) during 4 weeks, followed by a 3-week wash-out during which volunteers consumed the same amount of normal sunflower 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 (flow mediated dilation (FMD), 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.

Official Title
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Assessment of the Health Effects of Olive Pomace Oil in Healthy and at Risk Consumers

Conditions
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Healthy, Hypercholesterolemia

Intervention / Treatment
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* Other: Olive pomace oil
* Other: High oleic acid sunflower oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: After a 3-week run-in, healthy and at risk (hypercholesterolemic) volunteers were randomly allocated to one of each arm. Eas intervention stage lasted 4 weeks and was separated fy a 3-week wash-out.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olive pomace oil<br>Intake of 45 g/d of olive pomace oil as the only source of oil in the diet | Other: Olive pomace oil<br>* Volunteers consumed during 4 weeks 45 g/d of olive pomace oil as the only source of dietary fat, used for cooking, salad dressing, toasts, etc.<br>* Other names: OPO;|
| Active Comparator: High-oleic sunflower oil<br>Intake of 45 g/d of high-oleic sunflower oil as the only source of oil in the diet | Other: High oleic acid sunflower oil<br>* Volunteers consumed during 4 weeks 45 g/d of oleic acid-rich sunflower oil as the only source of dietary fat, used for cooking, salad dressing, toasts, etc.<br>* Other names: HOSO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipids | Changes on total or LDL-cholesterol levels or triglycerides in at risk (hypercholesterolemic) subjects. No effect on blood lipids expected in healthy (normocholesterolemic ) volunteers | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Changes in the levels of selectins, adhesion molecules or eNOS levels in volunteers | 4 weeks | 
| Blood pressure | Changes in systolic/diastolic blood pressure in volunteers | 4 weeks | 
| Glucose homeostasis | 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) | 4 weeks | 
| Inflammation | Changes in pro-inflammatory cytokines/C-reactive protein (CRP) levels | 4 weeks | 
| Oxidative status | Modification in serum antioxidant capacity (FRAP, ABTS, ORAC) and/or decreased levels of biomarkers of lipid oxidation (MDA, LDLox) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Olive pomace oil, Lipaemia, Glucose homeostasis, Inflammation, Oxidative stress biomarkers, Endothelial function