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

Effects of Sicilian red oranges on endothelial function and plasma antioxidant activity in adult subjects with increased cardiovascular risk: a randomised placebo-controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN39987296

Enrollment

Registered

2010-02-18

Start date

2010-03-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular and metabolic diseases Circulatory System Complications and ill-defined descriptions of heart disease

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 26, 2026