Health Effects of Consuming Olive Pomace Oil

NCT ID: NCT04997122

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-02
• Study Completion Date: 2018-07-13

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.

Conditions

Healthy; Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Olive pomace oil

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

Group Type: EXPERIMENTAL

Olive pomace oil

Intervention Type: OTHER

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.

High-oleic sunflower oil

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

Group Type: ACTIVE_COMPARATOR

High oleic acid sunflower oil

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

OPO; HOSO

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

OTHER_GOV

Sponsor Role: lead

Responsible Party

Raquel Mateos

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raquel Mateos, Dr

Role: PRINCIPAL_INVESTIGATOR

ICTAN-CSIC

Locations

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Madrid, , Spain

Countries

Spain

References

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. 2023 Mar;62(2):589-603. doi: 10.1007/s00394-022-03001-y. Epub 2022 Sep 24.

Reference Type: DERIVED

PMID: 36153442 (View on PubMed)

Other Identifiers

20175429

Identifier Type: -

Identifier Source: org_study_id