ORUJOSALUD-2: Health Effects of Consuming Olive Pomace Oil

Sponsor

Instituto de Ciencia y Tecnología de Alimentos y Nutrición (Other)

Overall Status

Completed

CT.gov ID

NCT04998695

Collaborator

(none)

Enrollment

Location

Arms

3.4

Actual Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Hypercholesterolemia	Other: Olive pomace oil Other: Sunflower oil	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

Single (Participant)

Masking Description:

Oils were provided in unlabelled bottles (only differed in the colors of stoppers)

Primary Purpose:

Basic Science

Official Title:

Differential Study of the Health Effects of Olive Pomace Oil in Healthy and at Risk Consumers in Comparison With Sunflower Oil

Actual Study Start Date :

Sep 9, 2019

Actual Primary Completion Date :

Dec 20, 2019

Actual Study Completion Date :

Dec 20, 2019

Arms and Interventions

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	Other: Olive 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. Other Names: OPO
Active Comparator: Sunflower oil Intake of 45 g/d of sunflower oil as the only source of oil in the diet	Other: Sunflower 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. Other Names: SO

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

Other: Olive 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.

Other Names:

OPO

Active Comparator: Sunflower oil

Intake of 45 g/d of sunflower oil as the only source of oil in the diet

Other: Sunflower 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.

Other Names:

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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