Oslo Antioxidant Study

This study has been completed.
Sponsor:
Collaborator:
Ullevaal University Hospital
Information provided by:
University of Oslo
ClinicalTrials.gov Identifier:
NCT00520819
First received: August 24, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

August 24, 2007
August 24, 2007
February 2003
Not Provided
Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage. [ Time Frame: 8 weeks ]
Same as current
No Changes Posted
Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage. [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
 
Oslo Antioxidant Study
Dietary Antioxidant Intervention in Smoking Middle-Aged and Elderly Men

The primary objective of this study is to test whether increasing the total intake of antioxidants to middle-aged smoking men increases the antioxidant defence, reduces oxidative damage, and improves biomarkers for oxidative stress.

The secondary objectives is to test whether this strategy improves other cardiovascular risk markers including platelet function, lipid levels, inflammation, and markers of endothelial damage.

In this study men smoking 5 or more cigarettes daily will be invited to participate. We will only include individuals with high cardiovascular risk (men rather than women, smokers rather than nonsmokers, middle-aged to elderly rather than young individuals), in order to recruit people with presumed high oxidative stress who might be most likely to show an effect and benefit from our intervention.

at the time of inclusion, participants will be randomized to three groups; control group, kiwi group or phytochemical group. The kiwi group will consume three kiwis a day, whereas the phytochemical group will consume an array of antioxidant-rich food stuffs. The intervention period is eight weeks.

Blood samples will be collected before and after the intervention period.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cardiovascular Disease
Drug: Antioxidant-rich food items
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
March 2005
Not Provided

Inclusion Criteria:

  • Men aged 45-75 years
  • Daily smoker of a minimum of 5 cigarettes a day
  • BMI <35 kg/m2 (because of difficulties that may be experienced by morbidly obese individuals in following the diet)
  • Stable weight range of 4 kg or less during the previous 12 weeks

Exclusion Criteria:

  • Any symptomatic CVD (myocardial infarction, angina pectoris, CABG, PCI, CHF, NYHA class III-IV)
  • Diabetes type I or type II taking drugs for diabetes
  • Following a vegetarian diet or near-vegetarian diet currently
  • Allergy to nuts, kiwi fruits, chocolate, strawberries or tomatoes
  • Clinical disorders including gastrointestinal disease impairing compliance with dietary recommendations
  • History of serious or unstable medical or psychiatric disorder
  • Current use of or need of lipid lowering drug treatment, aspirin or non-steroidal anti-inflammatory drugs (NSAID), according to assessment of the primary clinical investigator. Any "over the counter" headache/ pain or cold remedies taken during the study must not contain aspirin or aspirin like drugs such as ibuprofen. These are classed as and will interfere with platelet function, making them unresponsive for a period of 10-14 days. Paracetamol, however, can be taken as an alternative if required
  • History of alcohol/or drug abuse
  • Participation in a drug trial during the previous 30 days
  • Use of drugs (Xenical, Reductil), nutritional supplements or herbs for weight loss within the 4 weeks prior to visit 2 or participation in an active weight reduction program
  • Use of single vitamin or other antioxidants (must be stopped 4 weeks prior to visit 2)
  • Individuals judged by the clinical investigator to be unable to follow instructions and procedures of the study.
Male
45 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00520819
OAS
No
Not Provided
University of Oslo
Ullevaal University Hospital
Principal Investigator: Rune Blomhoff, PhD University of Oslo
Principal Investigator: Serena Tonstad, MD Ullevaal University Hospital
Principal Investigator: Anette Karlsen, MSc University of Oslo
University of Oslo
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP