Condition category
Circulatory System
Date applied
07/02/2010
Date assigned
18/02/2010
Last edited
19/06/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://portale.unipa.it/

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

  1. 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.

Additional files

Editorial Notes