NCT00920894

Brief Summary

This study aims to measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable

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

January 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 5, 2009

Status Verified

November 1, 2009

Enrollment Period

5 months

First QC Date

June 12, 2009

Last Update Submit

November 4, 2009

Conditions

Elevated Blood Lipids

Outcome Measures

Primary Outcomes (1)

  • plasma lipids

    10 weeks

Secondary Outcomes (1)

  • plasma lipoprotein lipids non-cholesterol sterols

    10 weeks

Study Arms (2)

yoghurt type minidrink containing plant stanol ester

EXPERIMENTAL
Dietary Supplement: plant stanol ester

yoghurt type minidrink without plant stanol ester

PLACEBO COMPARATOR
Dietary Supplement: plant stanol ester

Interventions

plant stanol esterDIETARY_SUPPLEMENT

the effect of plant stanol esters on plasma lipids

yoghurt type minidrink containing plant stanol esteryoghurt type minidrink without plant stanol ester

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elevated blood lipids
  • Body Mass Index \< 35 kg/m2
  • Stable body weight

You may not qualify if:

  • Receiving medications or supplements other than stable statin therapy known to affect lipid metabolism
  • Severe obesity
  • Hyperglycemia
  • Severe diseases (inc. diabetes, unstable CVD, malignant disease, inflammatory disease, gastrointestinal disease)
  • Hepatic, kidney or thyroid disease or disorder
  • Pregnancy or breast feeding
  • Severe intolerance or allergy to any ingredient of test product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Life Sciences Ltd

Vuokatti, 88610, Finland

Location

MeSH Terms

Interventions

plant stanol ester

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2009

First Posted

June 15, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2009

Study Completion

November 1, 2009

Last Updated

November 5, 2009

Record last verified: 2009-11

Locations

FI(1)