NCT00793364

Brief Summary

Since it is very difficult to have the real thing (Mediterranean diet) we need to find an alternative to reduce cardiovascular disease (CVD) risk in subjects with moderate hypercholesterolaemia (a major CVD risk factor) living in western countries. Therefore, this proposed study is designed to assess if giving olive oil supplements, with or without stanol ester, is equivalent to following a Mediterranean diet. Furthermore, the stanol-olive oil combination may prove to be superior to olive oil alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_4

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

November 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 28, 2009

Status Verified

May 1, 2009

Enrollment Period

4 months

First QC Date

November 17, 2008

Last Update Submit

May 27, 2009

Conditions

Hypercholesterolemia

Keywords

Cholesterol, stanol-ester, mediterranean diet, cardiac risk

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines.

    three months

Secondary Outcomes (1)

  • Change from baseline in major CVD risk factors [TC, LDL-C, HDL-C, TG, apoB], in an inflammatory marker [C-reactive protein], in hemostatic parameters (PAI-I, fibrinogen), liver function tests at the end of the study vs baseline.

    three months

Study Arms (3)

Stanol ester

ACTIVE COMPARATOR

Stanol-ester administration group

Dietary Supplement: Stanol ester spread

Placebo spread

PLACEBO COMPARATOR

Placebo spread group

Dietary Supplement: Placebo spread

Mediterranean diet group

OTHER

Mediterranean diet group

Dietary Supplement: Mediterranean Diet

Interventions

Stanol ester spreadDIETARY_SUPPLEMENT

Stanol ester spread 20 g every day

Also known as: Dietary Supplement
Stanol ester
Placebo spreadDIETARY_SUPPLEMENT

Placebo spread 20 g every day

Also known as: Dietary Supplement
Placebo spread
Mediterranean DietDIETARY_SUPPLEMENT

Mediterranean Diet every day

Also known as: Dietary Supplement
Mediterranean diet group

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects over 45 years of age with mild hypercholesterolaemia (TC levels: 200 mg/dl - 230 mg/dl)

You may not qualify if:

  • Subjects with
  • Established CVD (coronary heart disease, peripheral arterial disease, aortic aneurysm, or symptomatic carotid artery disease) or T2DM
  • Chronic diseases (including liver diseases)
  • Pregnancy
  • Malignancies
  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aristotelian University, Hippocration Hospital

Thessaloniki, 55132, Greece

Location

Related Publications (2)

  • Nguyen TT, Dale LC, von Bergmann K, Croghan IT. Cholesterol-lowering effect of stanol ester in a US population of mildly hypercholesterolemic men and women: a randomized controlled trial. Mayo Clin Proc. 1999 Dec;74(12):1198-206. doi: 10.4065/74.12.1198.

    PMID: 10593347RESULT

  • Athyros VG, Kakafika AI, Papageorgiou AA, Tziomalos K, Peletidou A, Vosikis C, Karagiannis A, Mikhailidis DP. Effect of a plant stanol ester-containing spread, placebo spread, or Mediterranean diet on estimated cardiovascular risk and lipid, inflammatory and haemostatic factors. Nutr Metab Cardiovasc Dis. 2011 Mar;21(3):213-21. doi: 10.1016/j.numecd.2009.08.014. Epub 2009 Nov 25.

    PMID: 19939653DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Dietary SupplementsDiet, Mediterranean

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDiet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological Phenomena

Study Officials

  • Vasilios G Athyros, MD

    Hippocration Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 19, 2008

Study Start

November 1, 2008

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

May 28, 2009

Record last verified: 2009-05

Locations

GR(1)