Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/10/2010
Date assigned
16/06/2011
Last edited
16/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Valentina Ruiz-Gutierrez

ORCID ID

Contact details

Instituto de la Grasa (CSIC)
Av. Padre García Tejero
4
Seville
41012
Spain
+34 (0)95 4611550
valruiz@ig.csic.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AGL2008-02285/ALI

Study information

Scientific title

A 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

Acronym

BIOTERPENOS

Study hypothesis

Oleanolic 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

The ethics committee (Comisión de Bioética [CSIC]), 4th of August 2008, ref: AGL2008-02285

Study design

Postprandial double blind interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Atherosclerosis

Intervention

1. 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Postprandial lipid composition of triglyceride-rich lipoproteins
2. Presence and concentration of oleanolic acid in serum and triglyceride-rich lipoproteins

Secondary outcome measures

1. 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 trial start date

01/01/2009

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy males not suffering from hypertriglyceridemia

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

12

Participant exclusion criteria

1. 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 date

01/01/2009

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Spain

Trial participating centre

Instituto de la Grasa (CSIC)
Seville
41012
Spain

Sponsor information

Organisation

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

Sponsor details

Deputy General of Research Projects
(Subdirección General de Proyectos de Investigación)
Albacete
5
Madrid
28027
Spain
+34 (0)91 6037743
informa@micinn.es

Sponsor type

Government

Website

http://www.micinn.es/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes