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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00520819
Study type Interventional
Source University of Oslo
Contact
Status Completed
Phase Phase 1/Phase 2
Start date February 2003
Completion date March 2005

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