Health Effects of Consuming Olive Pomace Oil

Not Applicable

Completed

• Conditions: Healthy; Hypercholesterolemia
• Interventions: Other: Olive pomace oil; Other: High oleic acid sunflower oil

• Registration Number: NCT04997122
• 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 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

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.

Study Timeline

• Study Start: 2018-04-02
• Primary Completion: 2018-07-13
• Study Completion: 2018-07-13
• Status Verified: 2021-08
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Last Update Submitted: 2021-08-08
• Study First Posted: 2021-08-09
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Olive pomace oil	Olive pomace oil	Intake of 45 g/d of olive pomace oil as the only source of oil in the diet
High-oleic sunflower oil	High oleic acid sunflower oil	Intake of 45 g/d of high-oleic sunflower oil as the only source of oil in the diet

Primary Outcome Measures

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

Trial Locations

Locations (1)

Instituto de Ciencia y Tecnología de Alimentos y Nutrición; 🇪🇸 Madrid, Spain