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 |
| Protocol serial number | 1/2010 |
| Sponsor | University of Palermo (Italy) |
| Funders | Ministry of Education and Research (Ministero dell'Università e della Ricerca - MURST) (Italy), Agrumaria Corleone s.p.a. Palermo (Italy) - provided red orange juice and placebo, Added 23/02/2010:, Onlus: Nutrition and Health (Associazione Onlus: Nutrizione e Salute) (Italy) |
- 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
Scientific
Dipartimento di Medicina Interna, Malattie Cardiovascolari e Nefrourologiche
Via del Vespro, 129
Palermo
90127
Italy
| Phone | +39 091 655 4580 |
|---|---|
| silbus@tin.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised 2 x 2 crossed placebo-controlled single blinded trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
1. Glycaemic profiles and variability, before period 1 and at the end of period 1 and 2 |
| Completion date | 31/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 24 |
| 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
90127
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
