Health Effects of Consuming Olive Pomace Oil (ORUJOSALUD-2)
Differential Study of the Health Effects of Olive Pomace Oil in Healthy and at Risk Consumers in Comparison With Sunflower Oil
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain, 28040
- Instituto de Ciencia y Tecnología de Alimentos y Nutrición
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Olive pomace oil
Intake of 45 g/d of olive pomace oil as the only source of oil in the diet
|
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.
Other Names:
|
|
ACTIVE_COMPARATOR: Sunflower oil
Intake of 45 g/d of sunflower oil as the only source of oil in the diet
|
Volunteers consumed during 4 weeks 45 g/d of sunflower oil as the only source of dietary fat, used for cooking, salad dressing, toasts, etc.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood lipids
Time Frame: 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
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endothelial function
Time Frame: 4 weeks
|
Modification in the levels of selectins, adhesion molecules, or eNOS levels in volunteers
|
4 weeks
|
|
Blood pressure
Time Frame: 4 weeks
|
Changes in systolic/diastolic blood pressure in volunteers
|
4 weeks
|
|
Glucose homeostasis
Time Frame: 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)
|
4 weeks
|
|
Inflammation
Time Frame: 4 weeks
|
Concentration of serum pro-inflammatory cytokines/C-Reactive protein (CRP) modified in participants
|
4 weeks
|
|
Oxidative status
Time Frame: 4 weeks
|
Modification of serum antioxidant capacity (FRAP, ABTS, ORAC, expressed as nM Trolox equivalents)
|
4 weeks
|
|
Lipid oxidation markers
Time Frame: 4 weeks
|
Concentration of biomarkers of lipid oxidation (MDA and/or LDLox) in serum modified
|
4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20193239
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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