Healthy, Hypercholesterolemia
Conditions
Keywords
Olive pomace oil, Lipaemia, Glucose homeostasis, Inflammation, Oxidative stress biomarkers, Endothelial function
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.
Interventions
OTHEROlive pomace oil
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.
OTHERSunflower oil
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.
Sponsors
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Oils were provided in unlabelled bottles (only differed in the colors of stoppers)
Intervention model description
After a 3-week run-in, healthy and at risk (hypercholesterolemic) volunteers were randomly allocated to one of each arm. Each intervention stage lasted 4 weeks and was separated by a 3-week wash-out.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Endothelial function | 4 weeks | Modification in the levels of selectins, adhesion molecules, or eNOS levels in volunteers |
| 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 |
| Inflammation | 4 weeks | Concentration of serum pro-inflammatory cytokines/C-Reactive protein (CRP) modified in participants |
Countries
Spain
Outcome results
None listed