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Completed

NCT Number: NCT04998695

Health Effects of Consuming Olive Pomace Oil

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.

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Key information

Conditions

Healthy Dyslipidemias Hypercholesterolemia Hyperlipidemias Inflammation Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: OPO

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.

Other names: SO

Primary outcomes

  1. Blood lipids

    Time frame: 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 outcomes

  1. Endothelial function

    Time frame: 4 weeks

    Modification in the levels of selectins, adhesion molecules, or eNOS levels in volunteers

  2. Blood pressure

    Time frame: 4 weeks

    Changes in systolic/diastolic blood pressure in volunteers

  3. Glucose homeostasis

    Time frame: 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)

  4. Inflammation

    Time frame: 4 weeks

    Concentration of serum pro-inflammatory cytokines/C-Reactive protein (CRP) modified in participants

  5. Oxidative status

    Time frame: 4 weeks

    Modification of serum antioxidant capacity (FRAP, ABTS, ORAC, expressed as nM Trolox equivalents)

  6. Lipid oxidation markers

    Time frame: 4 weeks

    Concentration of biomarkers of lipid oxidation (MDA and/or LDLox) in serum modified

Sponsors and collaborators

Lead sponsor

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Other Gov

Registry information

Official study title

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

Acronym: ORUJOSALUD-2

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2021
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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