Health Effects of Consuming Olive Pomace Oil (ORUJOSALUD-2)
Primary Purpose
Healthy, Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Olive pomace oil
Sunflower oil
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Olive pomace oil, Lipaemia, Glucose homeostasis, Inflammation, Oxidative stress biomarkers, Endothelial function
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
Sites / Locations
- Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Olive pomace oil
Sunflower oil
Arm Description
Intake of 45 g/d of olive pomace oil as the only source of oil in the diet
Intake of 45 g/d of sunflower oil as the only source of oil in the diet
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Endothelial function
Modification in the levels of selectins, adhesion molecules, or eNOS levels in volunteers
Blood pressure
Changes in systolic/diastolic blood pressure in volunteers
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)
Inflammation
Concentration of serum pro-inflammatory cytokines/C-Reactive protein (CRP) modified in participants
Oxidative status
Modification of serum antioxidant capacity (FRAP, ABTS, ORAC, expressed as nM Trolox equivalents)
Lipid oxidation markers
Concentration of biomarkers of lipid oxidation (MDA and/or LDLox) in serum modified
Full Information
NCT ID
NCT04998695
First Posted
August 4, 2021
Last Updated
August 9, 2021
Sponsor
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
1. Study Identification
Unique Protocol Identification Number
NCT04998695
Brief Title
Health Effects of Consuming Olive Pomace Oil
Acronym
ORUJOSALUD-2
Official Title
Differential Study of the Health Effects of Olive Pomace Oil in Healthy and at Risk Consumers in Comparison With Sunflower Oil
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Hypercholesterolemia
Keywords
Olive pomace oil, Lipaemia, Glucose homeostasis, Inflammation, Oxidative stress biomarkers, Endothelial function
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Participant
Masking Description
Oils were provided in unlabelled bottles (only differed in the colors of stoppers)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olive pomace oil
Arm Type
Experimental
Arm Description
Intake of 45 g/d of olive pomace oil as the only source of oil in the diet
Arm Title
Sunflower oil
Arm Type
Active Comparator
Arm Description
Intake of 45 g/d of sunflower oil as the only source of oil in the diet
Intervention Type
Other
Intervention Name(s)
Olive pomace oil
Other Intervention Name(s)
OPO
Intervention Description
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
Intervention Name(s)
Sunflower oil
Other Intervention Name(s)
SO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood lipids
Description
Reduction of total or LDL-cholesterol levels or triglycerides in at risk (hypercholesterolemic) subjects. No effect on blood lipids expected in healthy (normocholesterolemic) volunteers
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Endothelial function
Description
Modification in the levels of selectins, adhesion molecules, or eNOS levels in volunteers
Time Frame
4 weeks
Title
Blood pressure
Description
Changes in systolic/diastolic blood pressure in volunteers
Time Frame
4 weeks
Title
Glucose homeostasis
Description
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)
Time Frame
4 weeks
Title
Inflammation
Description
Concentration of serum pro-inflammatory cytokines/C-Reactive protein (CRP) modified in participants
Time Frame
4 weeks
Title
Oxidative status
Description
Modification of serum antioxidant capacity (FRAP, ABTS, ORAC, expressed as nM Trolox equivalents)
Time Frame
4 weeks
Title
Lipid oxidation markers
Description
Concentration of biomarkers of lipid oxidation (MDA and/or LDLox) in serum modified
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel Mateos, Dr
Organizational Affiliation
ICTAN-CSIC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Health Effects of Consuming Olive Pomace Oil
We'll reach out to this number within 24 hrs