Oslo Antioxidant Study

Cardiovascular Disease Clinical Trial

Official title:

Dietary Antioxidant Intervention in Smoking Middle-Aged and Elderly Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520819
• Other study ID #: OAS
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 24, 2007
• Last updated: August 24, 2007
• Start date: February 2003
• Est. completion date: March 2005

Study information

• Verified date: August 2007
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Antioxidant-rich food items

Locations

Country	Name	City	State
Norway	Ullevål University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo	Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage.		8 weeks
Secondary	Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage.		8 weeks