Effects of Sicilian red oranges on endothelial function and plasma antioxidant activity in adult subjects with increased cardiovascular risk

ISRCTN	ISRCTN39987296
DOI	https://doi.org/10.1186/ISRCTN39987296
Secondary identifying numbers	1/2010

Submission date: 07/02/2010
Registration date: 18/02/2010
Last edited: 19/06/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Silvio Buscemi
Scientific

Dipartimento di Medicina Interna, Malattie Cardiovascolari e Nefrourologiche
Via del Vespro, 129
Palermo
90127
Italy

Phone	+39 091 655 4580
Email	silbus@tin.it

Study information

Study design	Randomised 2 x 2 crossed placebo-controlled single blinded trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	Red oranges contain antioxidants that may improve endothelial function and plasma antioxidant capacity.
Ethics approval(s)	Local Ethical Committee of the University Hospital of Palermo (I) approved on the 3rd February 2010 (ref: 02/2010)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/03/2010
Completion date	31/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	14 - 20 subjects + 10 controls
Key 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
Key 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
Date of first enrolment	01/03/2010
Date of final enrolment	31/05/2010

Locations

Countries of recruitment

Italy

Study participating centre

Dipartimento di Medicina Interna, Malattie Cardiovascolari e Nefrourologiche

Palermo
90127
Italy

Sponsor information

University of Palermo (Italy)
University/education

Department of Internal Medicine, Cardiovascular and Kidney Diseases
Via del Vespro, 129
Palermo
90127
Italy

Email	nutrilab.unipa@gmail.com
Website	http://portale.unipa.it/
"ROR"	https://ror.org/044k9ta02

Funders

Funder type

Government

Ministry of Education and Research (Ministero dell'Università e della Ricerca - MURST) (Italy)
Government organisation / National government

Alternative name(s): Министерство образования и науки, Ministry of Education and Research, HM
Location: Estonia

Agrumaria Corleone s.p.a. Palermo (Italy) - provided red orange juice and placebo

No information available

Added 23/02/2010:

No information available

Onlus: Nutrition and Health (Associazione Onlus: Nutrizione e Salute) (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2012		Yes	No