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
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