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Oslo Antioxidant Study

This study has been completed.
Sponsor:
Collaborator:
Ullevaal University Hospital
Information provided by:
University of Oslo
ClinicalTrials.gov Identifier:
NCT00520819
First received: August 24, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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 Intervention Phase
Cardiovascular Disease
 Drug: Antioxidant-rich food items
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Dietary Antioxidant Intervention in Smoking Middle-Aged and Elderly Men

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants Smoking
U.S. FDA Resources

Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage. [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage. [ Time Frame: 8 weeks ]

Enrollment: 102
Study Start Date: February 2003
Study Completion Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520819

Locations
Norway
Ullevål University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
University of Oslo
Ullevaal University Hospital
Investigators
Principal Investigator: Rune Blomhoff, PhD University of Oslo
Principal Investigator: Serena Tonstad, MD Ullevaal University Hospital
Principal Investigator: Anette Karlsen, MSc University of Oslo
  More Information

No publications provided by University of Oslo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00520819     History of Changes
Other Study ID Numbers: OAS
Study First Received: August 24, 2007
Last Updated: August 24, 2007
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Oslo:
Antioxidants
Phytochemicals
Oxidative stress
Inflammation
Endothelial function

Additional relevant MeSH terms:
Cardiovascular Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013