Oslo Antioxidant Study

Sponsor

University of Oslo (Other)

Overall Status

Completed

CT.gov ID

NCT00520819

Collaborator

Ullevaal University Hospital (Other)

102

Enrollment

Location

24.9

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Drug: Antioxidant-rich food items	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Dietary Antioxidant Intervention in Smoking Middle-Aged and Elderly Men

Study Start Date :

Feb 1, 2003

Actual Study Completion Date :

Mar 1, 2005

Outcome Measures

Primary Outcome Measures

Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage. [8 weeks]

Secondary Outcome Measures

Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage. [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.