Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
102 participants
INTERVENTIONAL
2003-02-28
2005-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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Antioxidant-rich food items
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
75 Years
MALE
Yes
Sponsors
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Ullevaal University Hospital
OTHER
University of Oslo
OTHER
Principal Investigators
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Rune Blomhoff, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oslo
Serena Tonstad, MD
Role: PRINCIPAL_INVESTIGATOR
Ullevaal University Hospital
Anette Karlsen, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Oslo
Locations
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Ullevål University Hospital
Oslo, , Norway
Countries
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References
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Karlsen A, Svendsen M, Seljeflot I, Sommernes MA, Sexton J, Brevik A, Erlund I, Serafini M, Bastani N, Remberg SF, Borge GI, Carlsen MH, Bohn SK, Myhrstad MC, Dragsted LO, Duttaroy AK, Haffner K, Laake P, Drevon CA, Arnesen H, Collins A, Tonstad S, Blomhoff R. Compliance, tolerability and safety of two antioxidant-rich diets: a randomised controlled trial in male smokers. Br J Nutr. 2011 Aug;106(4):557-71. doi: 10.1017/S0007114511000353.
Bohn SK, Myhrstad MC, Thoresen M, Holden M, Karlsen A, Tunheim SH, Erlund I, Svendsen M, Seljeflot I, Moskaug JO, Duttaroy AK, Laake P, Arnesen H, Tonstad S, Collins A, Drevon CA, Blomhoff R. Blood cell gene expression associated with cellular stress defense is modulated by antioxidant-rich food in a randomised controlled clinical trial of male smokers. BMC Med. 2010 Sep 16;8:54. doi: 10.1186/1741-7015-8-54.
Other Identifiers
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OAS
Identifier Type: -
Identifier Source: org_study_id