Contact information
Type
Scientific
Primary contact
Prof Silvio Buscemi
ORCID ID
Contact details
Dipartimento di Medicina Interna
Malattie Cardiovascolari e Nefrourologiche
Via del Vespro
129
Palermo
90127
Italy
+39 091 655 4580
silbus@tin.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1/2010
Study information
Scientific title
Effects of Sicilian red oranges on endothelial function and plasma antioxidant activity in adult subjects with increased cardiovascular risk: a randomised placebo-controlled trial
Acronym
Study hypothesis
Red oranges contain antioxidants that may improve endothelial function and plasma antioxidant capacity.
Ethics approval
Local Ethical Committee of the University Hospital of Palermo (I) approved on the 3rd February 2010 (ref: 02/2010)
Study design
Randomised 2 x 2 crossed placebo-controlled single blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular and metabolic diseases
Intervention
Participants with increased cardiovascular risk will receive on two periods of 7 +/- 1 days (period 1 and 2) each with 3 days intervals, with a random order respectively 500 ml/day (250 ml twice daily [bid]) of red orange juice and 500 ml of placebo made up of orange aroma and colorant, water, 11 g of saccarose, 1 g of citric acid.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Endothelial function, measured as "flow mediated dilation", blood total oxidant and anti-oxidant capacity before period 1 and at the end of period 1 and 2.
Secondary outcome measures
1. Glycaemic profiles and variability, before period 1 and at the end of period 1 and 2
2. Different measures of leukocytes activation and of nitric oxide production, before period 1 and at the end of period 1 and 2
Overall trial start date
01/03/2010
Overall trial end date
31/05/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female subjects
2. Range of age 18 - 70 years
3. Body mass index (BMI) greater than 28 kg/m^2
4. Presence of at least two of the diagnostic criteria of the Metabolic Syndrome:
4.1. Waist circumference greater than 80 cm for women and 94 cm for men
4.2. Triglycerides greater than 150 mg/dl or use of lowering blood lipid drugs
4.3. High density lipoproteins (HDL)-cholesterol less than 50 mg/dl for women or 40 mg/dl for men
4.4. Blood pressure greater than 130 mmHg for systolic or greater than 85 mmHg for diastolic blood pressure
4.5. Fasting plasma glucose greater than 100 mg/dl
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
14 - 20 subjects + 10 controls
Participant exclusion criteria
1. Type 1 or 2 diabetes
2. Gastro-intestinal, connective diseases
3. Chronic pancreatitis, liver cirrhosis, kidney stones, renal failure
4. Use of acetyl-salicylic acid (ASA), other antiplatelet drugs, statins, oral hypoglycemic drugs, nitrates, non-steroidal anti-inflammatory drugs (NSAIDS), corticosteroids, drugs interfering with coagulation, supplements with vitamins and anti-oxidants
5. Pregnancy or lactation in the last six months
6. Regular sport activity
7. Denial of informed consent
Recruitment start date
01/03/2010
Recruitment end date
31/05/2010
Locations
Countries of recruitment
Italy
Trial participating centre
Dipartimento di Medicina Interna, Malattie Cardiovascolari e Nefrourologiche
Palermo
90127
Italy
Sponsor information
Organisation
University of Palermo (Italy)
Sponsor details
Department of Internal Medicine
Cardiovascular and Kidney Diseases
Via del Vespro
129
Palermo
90127
Italy
nutrilab.unipa@gmail.com
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Ministry of Education and Research (Ministero dell'Università e della Ricerca - MURST) (Italy)
Alternative name(s)
Ministry of Education and Research
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Estonia
Funder name
Agrumaria Corleone s.p.a. Palermo (Italy) - provided red orange juice and placebo
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Added 23/02/2010:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Onlus: Nutrition and Health (Associazione Onlus: Nutrizione e Salute) (Italy)
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
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22492368
Publication citations
-
Results
Buscemi S, Rosafio G, Arcoleo G, Mattina A, Canino B, Montana M, Verga S, Rini G, Effects of red orange juice intake on endothelial function and inflammatory markers in adult subjects with increased cardiovascular risk., Am. J. Clin. Nutr., 2012, 95, 5, 1089-1095, doi: 10.3945/ajcn.111.031088.