Health Effects of Consuming Olive Pomace Oil

NCT04998695 | Completed

• 1 other identifier: 20193239
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Hypercholesterolemia

Keywords

Olive pomace oil; Lipaemia; Glucose homeostasis; Inflammation; Oxidative stress biomarkers; Endothelial function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Endothelial function

  4 weeks

• Blood pressure

  4 weeks

• Glucose homeostasis

  4 weeks

• Inflammation

  4 weeks

• Oxidative status

  4 weeks

Study Arms (2)

Olive pomace oil

EXPERIMENTAL

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

Other: Olive pomace oil

Sunflower oil

ACTIVE COMPARATOR

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

Other: Sunflower oil

Interventions

Olive pomace oil 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.

Also known as: OPO

Olive pomace oil

Sunflower oil OTHER

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.

Also known as: SO

Sunflower oil

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias; Inflammation

Interventions

Sunflower Oil

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Raquel Mateos, Dr

  ICTAN-CSIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Oils were provided in unlabelled bottles (only differed in the colors of stoppers)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 10, 2021
• Study Start: September 9, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)