NCT00520819

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
Last Updated

August 27, 2007

Status Verified

August 1, 2007

First QC Date

August 24, 2007

Last Update Submit

August 24, 2007

Conditions

Cardiovascular Disease

Keywords

AntioxidantsPhytochemicalsOxidative stressInflammationEndothelial function

Outcome Measures

Primary Outcomes (1)

  • Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage.

    8 weeks

Secondary Outcomes (1)

  • Biomarkers cardiovascular risk including platelet function, lipid levels, inflammation, and markers of endothelial damage.

    8 weeks

Interventions

Antioxidant-rich food itemsDRUG

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevål University Hospital

Oslo, 0407, Norway

Location

Related Publications (2)

  • 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.

    PMID: 21806852DERIVED

  • 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.

    PMID: 20846424DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rune Blomhoff, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

  • Serena Tonstad, MD

    Ullevaal University Hospital

    PRINCIPAL INVESTIGATOR

  • Anette Karlsen, MSc

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 27, 2007

Study Start

February 1, 2003

Study Completion

March 1, 2005

Last Updated

August 27, 2007

Record last verified: 2007-08

Locations

NO(1)