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The Effect of Plant Sterol Supplement on Blood Cholesterol

Primary Purpose

High Blood Cholesterol Level

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Intake of plant sterols
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Blood Cholesterol Level

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men and women 18-80 years old
  • Total cholesterol: 4.5-7.5 mmol/l
  • Triglycerides at or below 4.0 mmol/l

Exclusion Criteria:

  • BMI at or above 35 kg/m2
  • Secondary hyperlipidemia, included diabetes
  • Hypertension (at og higher than 170/110)
  • Coronar, perifery or cerebral vascular disease last 3 months
  • Familial hypercholesterolemia
  • Change in dose of statins, oestrogen or contraceptives last 3 months
  • Taking drugs which are known to interfere with the plasma level of cholesterol
  • Chronic rheumatoid diseases or other diseases known to affect c-reactive protein
  • Pregnancy
  • Lactation
  • Planning to reduce weight
  • Taking plant sterols

Sites / Locations

  • Lipidklinikken, Rikshospitalet Radiumhospitalet HF
  • Rikshospitalet Radiumhospitalet HF, Oslo, Norway

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 11, 2007
Last Updated
June 30, 2011
Sponsor
Oslo University Hospital
Collaborators
Mills DA
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1. Study Identification

Unique Protocol Identification Number
NCT00485095
Brief Title
The Effect of Plant Sterol Supplement on Blood Cholesterol
Official Title
A Single Centre, Randomized Crossover Double-Blind Placebo-Controlled Study to Measure the Effect of Plant Sterol Supplement on Blood Cholesterol
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Oslo University Hospital
Collaborators
Mills DA

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether supplement of plant sterol could lower blood cholesterol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Cholesterol Level

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Intake of plant sterols

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women 18-80 years old Total cholesterol: 4.5-7.5 mmol/l Triglycerides at or below 4.0 mmol/l Exclusion Criteria: BMI at or above 35 kg/m2 Secondary hyperlipidemia, included diabetes Hypertension (at og higher than 170/110) Coronar, perifery or cerebral vascular disease last 3 months Familial hypercholesterolemia Change in dose of statins, oestrogen or contraceptives last 3 months Taking drugs which are known to interfere with the plasma level of cholesterol Chronic rheumatoid diseases or other diseases known to affect c-reactive protein Pregnancy Lactation Planning to reduce weight Taking plant sterols
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leiv Ose, MD
Organizational Affiliation
Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lipidklinikken, Rikshospitalet Radiumhospitalet HF
City
Oslo
Country
Norway
Facility Name
Rikshospitalet Radiumhospitalet HF, Oslo, Norway
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
23623012
Citation
Ottestad I, Ose L, Wennersberg MH, Granlund L, Kirkhus B, Retterstol K. Phytosterol capsules and serum cholesterol in hypercholesterolemia: a randomized controlled trial. Atherosclerosis. 2013 Jun;228(2):421-5. doi: 10.1016/j.atherosclerosis.2013.03.001. Epub 2013 Mar 20.
Results Reference
derived

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The Effect of Plant Sterol Supplement on Blood Cholesterol

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