Oslo Antioxidant Study
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| First Received Date ICMJE | August 24, 2007 | ||||||||||||
| Last Updated Date | August 24, 2007 | ||||||||||||
| Start Date ICMJE | February 2003 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage. [ Time Frame: 8 weeks ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | No Changes Posted | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage. [ Time Frame: 8 weeks ] | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Oslo Antioxidant Study | ||||||||||||
| Official Title ICMJE | Dietary Antioxidant Intervention in Smoking Middle-Aged and Elderly Men | ||||||||||||
| Brief 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. |
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| Detailed 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. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Cardiovascular Disease | ||||||||||||
| Intervention ICMJE | Drug: Antioxidant-rich food items | ||||||||||||
| Study Arm (s) | Not Provided | ||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 102 | ||||||||||||
| Completion Date | March 2005 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||||||
| Ages | 45 Years to 75 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Norway | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00520819 | ||||||||||||
| Other Study ID Numbers ICMJE | OAS | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Not Provided | ||||||||||||
| Study Sponsor ICMJE | University of Oslo | ||||||||||||
| Collaborators ICMJE | Ullevaal University Hospital | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Oslo | ||||||||||||
| Verification Date | August 2007 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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