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ISRCTN
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ISRCTN39987296
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ClinicalTrials.gov identifier
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Public title
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Effects of Sicilian red oranges on endothelial function and plasma antioxidant activity in adult subjects with increased cardiovascular risk
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Scientific title
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Effects of Sicilian red oranges on endothelial function and plasma antioxidant activity in adult subjects with increased cardiovascular risk: a randomised placebo-controlled trial
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Acronym
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N/A
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Serial number at source
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1/2010
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Study hypothesis
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Red oranges contain antioxidants that may improve endothelial function and plasma antioxidant capacity.
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Lay summary
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Ethics approval
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Local Ethical Committee of the University Hospital of Palermo (I) approved on the 3rd February 2010 (ref: 02/2010)
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Study design
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Randomised 2 x 2 crossed placebo-controlled single blinded trial
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Cardiovascular and metabolic diseases
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/03/2010
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Anticipated end date
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31/05/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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14 - 20 subjects + 10 controls
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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Sources of funding
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1. Ministry of Education and Research (Ministero dell'Università e della Ricerca - MURST) (Italy)
2. Agrumaria Corleone s.p.a. Palermo (Italy) - provided red orange juice and placebo
Added 23/02/2010:
3. Onlus: Nutrition and Health (Associazione Onlus: Nutrizione e Salute) (Italy)
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Trial website
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Publications
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Contact name
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Prof
Silvio
Buscemi
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Address
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Dipartimento di Medicina Interna, Malattie Cardiovascolari e Nefrourologiche
Via del Vespro, 129
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City/town
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Palermo
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Zip/Postcode
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90127
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Country
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Italy
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Tel
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+39 091 655 4580
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Fax
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+39 091 655 2144
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Email
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silbus@tin.it
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Sponsor
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University of Palermo (Italy)
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Address
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Department of Internal Medicine, Cardiovascular and Kidney Diseases
Via del Vespro, 129
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City/town
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Palermo
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Zip/Postcode
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90127
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Country
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Italy
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Email
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nutrilab.unipa@gmail.com
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Sponsor website:
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http://portale.unipa.it/
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Date applied
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07/02/2010
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Last edited
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23/02/2010
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Date ISRCTN assigned
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18/02/2010
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