Cardiovascular DiseasePhase 1/2NCT00520819
Oslo Antioxidant Study
A Phase 1/2 study testing Antioxidant-rich food items in people with Cardiovascular Disease, run by University of Oslo at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Antioxidant-rich food items
- How many people
- 102 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2003to Mar 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Antioxidant-rich food items
- Keywords
- Antioxidants, Phytochemicals, Oxidative stress, Inflammation, Endothelial function
- Medical subject headings
- Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antioxidant-rich food itemsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage.
Measured: 8 weeks
Secondary outcomes (1)
Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startFeb 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Ullevaal University Hospital
- Investigators
- Rune Blomhoff, PhD, Principal investigator, University of OsloSerena Tonstad, MD, Principal investigator, Ullevaal University HospitalAnette Karlsen, MSc, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520819
- Sponsor's protocol ID
- OAS
- Status last verified
- Aug 2007
- First submitted
- 24 Aug 2007
- Last updated
- 27 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21806852Bohn 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.
PubMed 20846424
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Antioxidant Intervention in Smoking Middle-Aged and Elderly Men
- ClinicalTrials.gov ID
- NCT00520819
- Acronym / sponsor ID
- OAS
- Conditions
- Cardiovascular Disease
- Keywords
- Antioxidants, Phytochemicals, Oxidative stress, Inflammation, Endothelial function
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Ullevaal University Hospital
- Study start
- Feb 2003
- Study completion
- Mar 2005 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antioxidant-rich food items | Drug | – |
Primary outcome
Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage.
Time frame: 8 weeks
1 secondary outcome
Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2007.
- Derived from this study: PubMed 21806852Karlsen 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.
- Derived from this study: PubMed 20846424Bohn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rune Blomhoff, PhD principal investigator
University of Oslo
Serena Tonstad, MD principal investigator
Ullevaal University Hospital
Anette Karlsen, MSc principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Antioxidant-rich food items in people with Cardiovascular Disease, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00520819, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2007.