Healia Clinical Trials Information Database

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.

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.

Status: Completed (Phase 1/Phase 2). Started on February 1st, 2003. Ended on March 1st, 2005.

Enrollment: 102 subjects

Study Type: Interventional

Study Design:

  • Prevention
  • Randomized
  • Open Label
  • Active Control
  • Parallel Assignment
  • Safety/Efficacy Study

Conditions:

Interventions:

  • Drug: Antioxidant-rich food items

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.

Gender

Male

Mininum Age

45 Years

Maximum Age

75 Years

Healthy Volunteers

Accepts Healthy Volunteers


Resources

Source: University of Oslo

Authority: Norway: The National Committees for Research Ethics in Norway

Locations

  • Ullevål University Hospital
    Oslo
    0407
    Norway

Officials

  • Rune Blomhoff, PhD (Principal Investigator, University of Oslo)

  • Serena Tonstad, MD (Principal Investigator, Ullevaal University Hospital)

  • Anette Karlsen, MSc (Principal Investigator, University of Oslo)

Sponsors

  • University of Oslo (Lead Sponsor)

  • Ullevaal University Hospital (Collaborator)

References

None.

Links

None.


Date Verified
August 1st, 2007
First Received
August 24th, 2007
Last Changed
August 24th, 2007

Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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