Health Effects of Consuming Olive Pomace Oil

Healthy Clinical Trial

— ORUJOSALUD-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04998695
• Other study ID #: 20193239
• Status: Completed
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: August 2021
• Source: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Hypercholesterolemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Instituto de Ciencia y Tecnología de Alimentos y Nutrición	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood lipids	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	Endothelial function	Modification in the levels of selectins, adhesion molecules, or eNOS levels in volunteers	4 weeks
Secondary	Blood pressure	Changes in systolic/diastolic blood pressure in volunteers	4 weeks
Secondary	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
Secondary	Inflammation	Concentration of serum pro-inflammatory cytokines/C-Reactive protein (CRP) modified in participants	4 weeks
Secondary	Oxidative status	Modification of serum antioxidant capacity (FRAP, ABTS, ORAC, expressed as nM Trolox equivalents)	4 weeks
Secondary	Lipid oxidation markers	Concentration of biomarkers of lipid oxidation (MDA and/or LDLox) in serum modified	4 weeks