HealthyORUJOSALUD-2NCT04998695
Health Effects of Consuming Olive Pomace Oil
A study testing Olive pomace oil and Sunflower oil in people with Healthy and Hypercholesterolemia, run by Instituto de Ciencia y Tecnología de Alimentos y Nutrición at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hypercholesterolemia
- What is being tested?
- Olive pomace oil and Sunflower oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 9 Sep 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Madrid, 28040
About this study
Official title: Differential Study of the Health Effects of Olive Pomace Oil in Healthy and at Risk Consumers in Comparison With Sunflower 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.
Read the 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.
- Conditions
- Healthy, Hypercholesterolemia
- Being tested
- Olive pomace oil, Sunflower oil
- Keywords
- Olive pomace oil, Lipaemia, Glucose homeostasis, Inflammation, Oxidative stress biomarkers, Endothelial function
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive pomace oilOther
Also called OPO
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.
Sunflower oilOther
Also called SO
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.
| Study group | Role | What they receive |
|---|---|---|
| Olive pomace oil | Experimental | Intake of 45 g/d of olive pomace oil as the only source of oil in the diet Receives: 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 Receives: Other: Sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (6)
Endothelial function
Modification in the levels of selectins, adhesion molecules, or eNOS levels in volunteers
Measured: 4 weeks
Blood pressure
Changes in systolic/diastolic blood pressure in volunteers
Measured: 4 weeks
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)
Measured: 4 weeks
Inflammation
Concentration of serum pro-inflammatory cytokines/C-Reactive protein (CRP) modified in participants
Measured: 4 weeks
Oxidative status
Modification of serum antioxidant capacity (FRAP, ABTS, ORAC, expressed as nM Trolox equivalents)
Measured: 4 weeks
Lipid oxidation markers
Concentration of biomarkers of lipid oxidation (MDA and/or LDLox) in serum modified
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start9 Sep 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Ciencia y Tecnología de Alimentos y Nutrición
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Laura Bravo, Instituto de Ciencia y Tecnología de Alimentos y Nutrición
- Investigators
- Raquel Mateos, Dr, Principal investigator, ICTAN-CSIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998695
- Sponsor's protocol ID
- 20193239
- Acronym
- ORUJOSALUD-2
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Study of the Health Effects of Olive Pomace Oil in Healthy and at Risk Consumers in Comparison With Sunflower Oil
- ClinicalTrials.gov ID
- NCT04998695
- Acronym / sponsor ID
- ORUJOSALUD-2 / 20193239
- Conditions
- Healthy, Hypercholesterolemia
- Keywords
- Olive pomace oil, Lipaemia, Glucose homeostasis, Inflammation, Oxidative stress biomarkers, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Instituto de Ciencia y Tecnología de Alimentos y NutriciónOther government
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Olive pomace oil | Experimental | Other: Olive pomace oilIntake of 45 g/d of olive pomace oil as the only source of oil in the diet |
| Sunflower oil | Active comparator | Other: Sunflower oilIntake of 45 g/d of sunflower oil as the only source of oil in the diet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- BMI > 30 Kg/m2
- Smokers
- Vegetarians
- Pregnant women
- Medication/consumption of vitamins, dietary supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive pomace oilAlso: OPOVolunteers 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 | Olive pomace oil |
| Sunflower oilAlso: SOVolunteers 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 | Sunflower oil |
Primary outcome
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
6 secondary outcomes
Endothelial function
Time frame: 4 weeks
Blood pressure
Time frame: 4 weeks
Glucose homeostasis
Time frame: 4 weeks
Inflammation
Time frame: 4 weeks
Oxidative status
Time frame: 4 weeks
Lipid oxidation markers
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel Mateos, Dr principal investigator
ICTAN-CSIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive pomace oil and Sunflower oil in people with Healthy and Hypercholesterolemia, run by Instituto de Ciencia y Tecnología de Alimentos y Nutrición at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood lipids (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.