Health Effects of Consuming Olive Pomace Oil (ORUJOSALUD-1)

Assessment of the Health Effects of Olive Pomace Oil in Healthy and at Risk Consumers

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Hypercholesterolemia
• Intervention / Treatment: Other: Olive pomace oil; Other: High oleic acid sunflower oil

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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 Assignment
• Masking: Single

Number of Arms

2

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	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: High-oleic sunflower oil; Intake of 45 g/d of high-oleic sunflower oil as the only source of oil in the diet	Other: High oleic acid sunflower oil; Volunteers consumed during 4 weeks 45 g/d of oleic acid-rich sunflower oil as the only source of dietary fat, used for cooking, salad dressing, toasts, etc.; Other Names: HOSO

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Publications and helpful links

General Publications

• Gonzalez-Ramila S, Sarria B, Seguido MA, Garcia-Cordero J, Mateos R, Bravo L. Olive pomace oil can improve blood lipid profile: a randomized, blind, crossover, controlled clinical trial in healthy and at-risk volunteers. Eur J Nutr. 2022 Sep 24. doi: 10.1007/s00394-022-03001-y. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): July 13, 2018
• Study Completion (Actual): July 13, 2018

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 8, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Endothelial function; Oxidative stress biomarkers; Glucose homeostasis; Olive pomace oil; Lipaemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 20175429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No