Condition category
Circulatory System
Date applied
24/11/2009
Date assigned
06/04/2010
Last edited
06/04/2010
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

Dr Rosa Maria Lamuela-Raventos

ORCID ID

Contact details

Av. Joan XXIII s/n
Barcelona
08028
Spain
+34 (0)934034843
lamuela@ub.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AGL2007-66638-C02-01/ALI

Study information

Scientific title

Bioavailability of phenolic compounds from tomato depending on its processing. Effects of processing of tomato on cellular and serum biomarkers related to atherosclerosis: An open randomized cross-over controlled trial.

Acronym

Food Matrix Effect on Inflammatory Response

Study hypothesis

Processing of tomato with and without olive oil will release the polyphenolic compounds from the complex matrix and increase their bioavailability. Thus, intake of processed tomato will reduce cellular and inflammatory biomarkers related to atherosclerosis. No adverse effects will be observed.

Ethics approval

Institutional Review Board of the Hospital Clinic, Barcelona, Spain approved on the 9th November 2006 (ref: 2006/3351)

Study design

Open randomised crossover controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Written material on the protocol and the diet that should be followed by the subjects is administered at admission. Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Bioavailability and Atherosclerosis

Intervention

Intervention 1: Administration of 7.14 g/kg of body weight of fresh tomato.
Intervention 2: Administration of 3.57 g/kg of body weight of tomato sauce cooked with refined olive oil.
Intervention 3: Administration of 3.57 g/kg of body weight of tomato sauce cooked without oil.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Leukocyte adhesion molecule expression:
Peripheral lymphocyte and monocyte adhesion molecules on these cells will be marked with monoclonal antibodies (MAb) conjugated with fluorescein-isothiocyanate (FITC) and phycoerythrin (PE) by direct double immunofluorescence.
1.1. MAb used to mark adhesion molecules:
1.1.1. Anti-CD11a (LFA-1) (Bender MedSystems Diagnostics, Vienna)
1.1.2. Anti-CD40L (Bender MedSystems Diagnostics, Vienna)
1.1.3. Anti-CD11b (Mac-1) (Bender MedSystems Diagnostics, Vienna)
1.1.4. Anti-Syalil Lewis (anti-CD15s) (Pharmingen, San Diego, CA)
1.1.5. Anti-CD49d (VLA-4) (Cytogmos)
1.2. MAb used to mark T-lymphocytes: anti-CD2 (Caltag Laboratories, Burlingame, CA)
1.2. MAb used to mark monocytes: anti-CD14 (Caltag Laboratories, Burlingame, CA)

2. Soluble adhesion molecules:
The following serum soluble adhesion molecules (1-4) and other molecules (5-7) will be determined by enzyme-linked immunosorbent assay (ELISA) kits (Immunotech):
2.1. Soluble intercellular adhesion molecule-1 (sICAM-1)
2.2. Soluble vascular adhesion molecule 1 (sVCAM-1)
2.3. sE-selectin
2.4. sP-selectin
2.5. Soluble monocyte chemotactic protein-1 (sMCP-1)
2.6. Tumour necrosis factor-alpha (TNF-a)
2.7. Interleukin 1a (IL-1a)
3. Plasma and urine functional components study:
3.1. Plasma polyphenol concentration will be determined by Liquid Chromatography Tandem Mass Spectrometry (LC/MS/MS). The plasma polyphenol determinations will be carried out at 8 points during the 24h study, and urine polyphenol determinations at 0-6, 6-12 and 12-24 hours periods with the objective to obtain the plasma and urine phenolics kinetic and to investigate the different kinetic parameters used to evaluate their bioavailability; Area under the Curve (AUC), maximum concentration (Cmax), time to maximum plasma concentration (Tmax) and Time to maximum response (TMR).
3.2. Other studies to be carried out on the plasma and urine samples include:
3.2.1. Antioxidant capacity (Trolox-Equivalent Antioxidant Capacity [TEAC] assay, Oxygen Radical Absorbance Capacity [ORAC] assay)
3.2.2. Total phenolic concentration (Folin-Ciocalteu method)
3.2.3. Total Radical-trapping Antioxidant Parameter (TRAP) assay
3.2.4. Ferric Reducing Antioxidant Power (FRAP) assay

All variables (primary and secondary outcomes) will be measured at baseline and after each intervention.

Secondary outcome measures

1. Medical record:
1.1. A complete medical record will be obtained from all participants, which includes data on tomato intake, smoking and dietary habits.
1.2. Blood pressure and heart rate will be measured with an electronic apparatus Omron HEM-705CP (Netherlands).

2. Nutrition assessment and general analyses:
2.1. All participants will complete a validated nutritional questionnaire at baseline to determine the total quantity of calories ingested in the previous month as well as the proportion corresponding to carbohydrates, lipids and proteins.
2.2. Overall nutrition will be determined by percentage of ideal weight, lean body mass and body mass index.
2.3. Waist perimeter will be measured.
2.4. The following measurements will also be obtained:
2.4.1. Red blood cell count
2.4.2. Haematocrit
2.4.3. Mean corpuscular volume
2.4.4. Leukocyte count
2.4.5. Glucose
2.4.6. Creatinine
2.4.7. Electrolytes
2.4.8. Uric acid
2.4.9. Transaminases
2.4.10. Lactate dehydrogenase
2.4.11. Alkaline phosphatase
2.4.12. Gamma-glutamyl transpeptidase
2.4.13. Bilirubin

3. Coagulation tests:
3.1. Platelet count
3.2. Prothrombin time
3.3. Plasma fibrinogen

4. Serum lipoprotein levels and others
4.1. Total cholesterol
4.2. Triglycerides
4.3. HDL cholesterol (cHDL)
4.4. cLDL
4.5. Apo A1
4.6. Apo B

5. Diet and exercise monitoring:
Monitoring of the diet and physical exercise will be carried out before and after each intervention.
5.1. All participants will follow an isocaloric diet prepared according to their personal preferences. The diet will be strictly monitored during the study. Diet compliance will be assessed from 7-days diet records administered before each evaluation. The foods ingested will be converted into nutritional values with the aid of the Professional Diet Balancer software (Cardinal Health Systems, Inc., Edina, MN).
5.2. Physical activity will also be evaluated with the Minnesota Leisure Time Physical Activity questionnaire which has also been validated in Spain.

All variables (primary and secondary outcomes) will be measured at baseline and after each intervention.

Overall trial start date

03/11/2008

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy adults (males and females)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Previous history of cardiovascular disease (ischemic heart disease - angina or recent or old myocardial infarction, cerebral vascular accident, or peripheral vascular disease)
2. Homeostatic disorders
3. Any several chronic diseases
4. Hypertension or dislipemia
5. Smoking subjects
6. Alcoholism
7. Other toxic substance abuse

Recruitment start date

03/11/2008

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Av. Joan XXIII s/n
Barcelona
08028
Spain

Sponsor information

Organisation

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

Sponsor details

c/Albacete
5
Madrid
28027
Spain

Sponsor type

Government

Website

http://web.micinn.es/

Funders

Funder type

Government

Funder name

Spanish Ministry of Science and Innovation (Ministerio de Ciencia e Innovación [MICINN]) (Spain) (AGL2007-66638-C02-01/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