Study of the bioavilability of triterpenoids from pomace oil and their role on processes involved in the formation of the atheroclerotic plaque

ISRCTN ISRCTN22685192
DOI https://doi.org/10.1186/ISRCTN22685192
Secondary identifying numbers AGL2008-02285/ALI
Submission date
08/10/2010
Registration date
16/06/2011
Last edited
16/06/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Prof Valentina Ruiz-Gutierrez
Scientific

Instituto de la Grasa (CSIC)
Av. Padre García Tejero, 4
Seville
41012
Spain

+34 (0)95 4611550
valruiz@ig.csic.es

Study information

Study designPostprandial double blind interventional study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleA double-blind, randomised controlled trial to assess the bioavilability of triterpenoids from pomace oil and their role on processes involved in the formation of the atheroclerotic plaque
Study acronymBIOTERPENOS
Study hypothesisOleanolic acid, a bioactive component of pomace olive oil is bioavailable in relation to its protective effect on processes involved in the beginning and progression of the atherosclerotic plaque
Ethics approval(s)The ethics committee (Comisión de Bioética [CSIC]), 4th of August 2008, ref: AGL2008-02285
ConditionAtherosclerosis
Intervention1. Administration of meals in fasting conditions
2. Each meal will provide the same nutrient compositon but the fat source will change
3. Three different fat sources will be compared:
3.1. Virgin olive oil
3.2. Pomace olive oil
3.3. Pomace olive oil enriched in oleanolic acid up to 600 ppm
4. Each subject consume a test meal of consisting of brown bread (71g) spread with 50g of one of the three oils followed by a skimmed yoghurt (125g), with a 1 week wash-out period between each test meal
5. The subjects are asked to refrain from consuming alcohol or smoking 24h before each experiment
6. Blood samples asre taken 2 and 4h postprandially
7. During this time the subjects are allowed to drink water and/or decaffeinated coffee ad libitum
Intervention typeOther
Primary outcome measure1. Postprandial lipid composition of triglyceride-rich lipoproteins
2. Presence and concentration of oleanolic acid in serum and triglyceride-rich lipoproteins
Secondary outcome measures1. Foam cell formation from macrophages (THP-1 cell line) after treatment with postpandial triglyceride-rich lipoproteins
2. Release of inflammation markers by macrophages (THP-1 cell line) after treatment with postpandial triglyceride-rich lipoproteins
3. Receptor expression in macrophages (THP-1 cell line) after treatment with postpandial triglyceride-rich lipoproteins
Overall study start date01/01/2009
Overall study end date31/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants12
Participant inclusion criteriaHealthy males not suffering from hypertriglyceridemia
Participant exclusion criteria1. Age lower than 18 years and higher than 55 years
2. Hypertriglyceridemia
3. Hypertension
4. Coronary heart disease (CHD)
5. Renal or hepatic disease
6. Obesity
7. Diabetes
8. Alcoholism
9. Smoking
10. Under pharmacological treatment affecting lipid metabolism, coagulation or any condition of the study
Recruitment start date01/01/2009
Recruitment end date31/12/2011

Locations

Countries of recruitment

  • Spain

Study participating centre

Instituto de la Grasa (CSIC)
Seville
41012
Spain

Sponsor information

Spanish Ministry of Science and Innovation (Ministerio de Ciencia e Innovación [MICINN]) (Spain)
Government

Deputy General of Research Projects
(Subdirección General de Proyectos de Investigación)
Albacete, 5
Madrid
28027
Spain

+34 (0)91 6037743
informa@micinn.es
http://www.micinn.es/

Funders

Funder type

Government

Spanish Ministry of Science and Innovation (Ministerio de Ciencia e Innovación [MICINN]) (Spain) - Plan Nacional de I+D+I (ref: AGL2008-02285/ALI)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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