NCT00441480

Brief Summary

The purpose of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2007

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

First Submitted

Initial submission to the registry

February 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 14, 2009

Completed
Last Updated

January 13, 2012

Status Verified

January 1, 2012

Enrollment Period

1.3 years

First QC Date

February 28, 2007

Results QC Date

July 1, 2009

Last Update Submit

January 12, 2012

Conditions

Dyslipidemia

Keywords

HypercholesterolemiaHypertriglyceridemiaPlant sterolCholesterolFish oil

Outcome Measures

Primary Outcomes (2)

  • LDL Cholesterol

    Average of blood test results at -10 and 0 days (before and after run-in period)

    at baseline

  • LDL-C

    Blood test results following 12 weeks of intervention

    12 weeks

Secondary Outcomes (12)

  • Triglycerides

    at baseline

  • Triglycerides

    12 weeks

  • Total Cholesterol

    at baseline

  • Total Cholesterol

    12 weeks

  • HDL Cholesterol

    at baseline

  • +7 more secondary outcomes

Study Arms (2)

Plant sterol esters

ACTIVE COMPARATOR

plant sterols esterified to fish oil fatty acids

Dietary Supplement: Plant sterols esters

placebo

PLACEBO COMPARATOR

Corn oil

Dietary Supplement: placebo

Interventions

Plant sterols estersDIETARY_SUPPLEMENT

1.6g phytosterols and 1.3g omega-3 fatty acids per day

Also known as: PS-FO
Plant sterol esters
placeboDIETARY_SUPPLEMENT

4 gr of corn oil

placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, \>18 years old and ≤ 70 years old, capable and willing to give written informed consent.
  • Subject must have hyperlipidemia at the screening visit and at the end of the run-in period, defined as: fasting plasma triglycerides \> 150 mg/dl and \< 500 mg/dl, LDL-cholesterol \> 130 mg/dl and \< 190 mg/dl.
  • Fasting plasma glucose (FPG) levels at the screening visit \< 110 mg/dl.
  • Female patient who is of reproductive potential agree to use acceptable methods of birth control
  • Female patient who is currently receiving hormone replacement therapy continuously 12 weeks before visit 1 (on stable dose) and will agree to do so during the study.

You may not qualify if:

  • Receiving medications or supplements known to affect lipid metabolism.
  • Uncontrolled hypertension or thyroid disease.
  • Consume unusual diets - will be determined at the discretion of the investigator.
  • Gained or lost more than 3 kg during the run-in period.
  • Patient has history of malignancy ≤ 5 years.
  • Patients with clinical ischemic CV disease on treatment
  • Consume 200 grams fish x 2 a week.
  • Gastrointestinal disease or any disease that the investigator feels would compromise the patient safety or limit his/her successful participation to the study.
  • Patient has type 1 or type 2 diabetes mellitus.
  • Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
  • Patient has had active peptic ulcer disease within 3 months of visit 1.
  • Woman patient is pregnant or breast-feeding or expecting to conceive during the study.
  • Patient has a history of hypersensitivity or allergy to fish, fish oil, corn oil or soy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Tel Litwinsky, 52621, Israel

Location

Related Publications (1)

  • Bitzur R, Cohen H, Cohen T, Dror TW, Herzog Y, Lifshitz Y, Lubish T, Harats D, Rubinstein A. The metabolic effects of omega-3 plant sterol esters in mixed hyperlipidemic subjects. Cardiovasc Drugs Ther. 2010 Dec;24(5-6):429-37. doi: 10.1007/s10557-010-6249-5.

    PMID: 20617456DERIVED

MeSH Terms

Conditions

DyslipidemiasHypercholesterolemiaHypertriglyceridemia

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperlipidemias

Results Point of Contact

Title
Prof. Dror Harats
Organization
The Institute for Lipid and Atherosclerosis Research and Internal Medicine C, Sheba Medical Center, Tel Hashomer
dror@vbl.co.il
972-3-5302940

Study Officials

  • Dror Harats, M.D.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 1, 2007

Study Start

March 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 13, 2012

Results First Posted

August 14, 2009

Record last verified: 2012-01

Locations

IL(1)