Clinical trial NCT04997122: Health Effects of Consuming Olive Pomace Oil
Official title: Assessment of the Health Effects of Olive Pomace Oil in Healthy and at Risk Consumers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Hypercholesterolemia
Keywords: Olive pomace oil
Lipaemia
Glucose homeostasis
Inflammation
Oxidative stress biomarkers
Endothelial function
Lead sponsor: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Sponsor class: OTHER_GOV
First posted: 2021-08-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: After a 3-week run-in, healthy and at risk (hypercholesterolemic) volunteers were randomly allocated to one of each arm.

Eas intervention stage lasted 4 weeks and was separated fy a 3-week wash-out.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Blood lipids
timeFrame: 4 weeks
Secondary outcomes:
measure: Endothelial function
timeFrame: 4 weeks
measure: Blood pressure
timeFrame: 4 weeks
measure: Glucose homeostasis
timeFrame: 4 weeks
measure: Inflammation
timeFrame: 4 weeks
measure: Oxidative status
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Study officials:
affiliation: ICTAN-CSIC
name: Raquel Mateos, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.