NCT00764010

Brief Summary

The study was actuated to evaluate the effects of a 3-year intervention with diet and/or very long chain omega-3 (VLC n-3 PUFA), in a randomized 2x2 factorial design on the progression of atherosclerosis in a high risk population. A total of 563 elderly men were included and randomized to receive usual care and VLC n-3 placebo capsules (control group), dietary advice and VLC n-3 placebo capsules, usual care and VLC n-3 capsules, and finally both VLC n-3 capsules and dietary advice. The evaluation of atherosclerosis were i) ultrasound measurement of carotid intima media thickening ii) pulse wave propagation time iii) circulating biomarkers of atherosclerosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
563

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 1997

Longer than P75 for phase_3

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

May 1, 1997

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
Last Updated

July 1, 2011

Status Verified

September 1, 2008

Enrollment Period

4.6 years

First QC Date

September 26, 2008

Last Update Submit

June 30, 2011

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers

    1997-2010

Secondary Outcomes (1)

  • Genetical influence of the intervention principles ("Nutrigenetics")

    1997-2010

Study Arms (4)

1

NO INTERVENTION

No dietary counseling, placebo capsules for omega-3

2

ACTIVE COMPARATOR

Dietary counseling, placebo capsules for omega-3

Dietary Supplement: Dietary counseling, placebo capsules for omega-3

3

ACTIVE COMPARATOR

No dietary counseling, omega-3 capsules

Dietary Supplement: No dietary counseling and omega-3 capsules

4

ACTIVE COMPARATOR

Dietary counseling and omega-3 capsules

Dietary Supplement: Omega-3 capsules and dietary counseling

Interventions

No dietary counseling and omega-3 capsulesDIETARY_SUPPLEMENT

Omega-3 2.4 g/day

3
Omega-3 capsules and dietary counselingDIETARY_SUPPLEMENT

Omega-3 2.4 g/day and Mediterranean-like diet

4
Dietary counseling, placebo capsules for omega-3DIETARY_SUPPLEMENT

Mediterranean-like diet

2

Eligibility Criteria

Age64 Years - 76 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly men with long standing hypercholesterolemia (cholesterol \> 6.45 mmol/L and \< 8.00 mmol/L) with or without coronary heart disease.

You may not qualify if:

  • Cholesterol \> 8.00 mmol/L, blood pressure \> 170/100
  • Uncontrolled hypertension
  • Socially or otherwise unsuitable subjects
  • Anticipated non compliance
  • Other major non cardiac illness expected to reduce life expectancy or interfere with study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevål University Hospital

Oslo, Oslo County, 0407, Norway

Location

Related Publications (3)

  • Awoyemi A, Troseid M, Arnesen H, Solheim S, Seljeflot I. Markers of metabolic endotoxemia as related to metabolic syndrome in an elderly male population at high cardiovascular risk: a cross-sectional study. Diabetol Metab Syndr. 2018 Jul 21;10:59. doi: 10.1186/s13098-018-0360-3. eCollection 2018.

    PMID: 30038669DERIVED

  • Weiss TW, Arnesen H, Seljeflot I. Components of the interleukin-6 transsignalling system are associated with the metabolic syndrome, endothelial dysfunction and arterial stiffness. Metabolism. 2013 Jul;62(7):1008-13. doi: 10.1016/j.metabol.2013.01.019. Epub 2013 Feb 19.

    PMID: 23428306DERIVED

  • Einvik G, Ekeberg O, Klemsdal TO, Sandvik L, Hjerkinn EM. Physical distress is associated with cardiovascular events in a high risk population of elderly men. BMC Cardiovasc Disord. 2009 Mar 30;9:14. doi: 10.1186/1471-2261-9-14.

    PMID: 19331677DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

Docosahexaenoic AcidsNutrition Assessment

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Harald Arnesen, M.D, PhD

    Ullevaal University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2008

First Posted

October 1, 2008

Study Start

May 1, 1997

Primary Completion

December 1, 2001

Study Completion

December 1, 2001

Last Updated

July 1, 2011

Record last verified: 2008-09

Locations

NO(1)