NCT00485095

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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

January 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2007

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

July 1, 2011

Status Verified

February 1, 2009

Enrollment Period

6 months

First QC Date

June 11, 2007

Last Update Submit

June 30, 2011

Conditions

High Blood Cholesterol Level

Interventions

Intake of plant sterolsBEHAVIORAL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lipidklinikken, Rikshospitalet Radiumhospitalet HF

Oslo, Norway

Location

Rikshospitalet Radiumhospitalet HF, Oslo, Norway

Oslo, Norway

Location

Related Publications (1)

  • 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.

    PMID: 23623012DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Leiv Ose, MD

    Lipidklinikken, Rikshospitalet-Radiumhospitalet HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 12, 2007

Study Start

January 1, 2007

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

July 1, 2011

Record last verified: 2009-02

Locations

NO(2)