NCT00698256

Brief Summary

The aim was to investigate the effects of the consumption of high doses of plant stanol esters on concentrations of serum lipids, carotenoids and fat soluble vitamins. In addition, we investigated the metabolism of absorbed plant sterols from intestine without and with the consumption of plant stanol esters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2008

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

February 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 17, 2012

Status Verified

April 1, 2012

Enrollment Period

3 months

First QC Date

June 12, 2008

Last Update Submit

April 16, 2012

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Serum lipids, Serum fat soluble vitamins and carotenoids, squalene and non-cholesterol sterols

    baseline, at weeks 9, 10 and 14

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: vegetable oil-based spread and oat-based drink (no brand name available)

2

PLACEBO COMPARATOR
Dietary Supplement: vegetable oil-based spread and oat-based drink (no brand name available)

Interventions

vegetable oil-based spread and oat-based drink (no brand name available)DIETARY_SUPPLEMENT

spread and drink (9 g stanols/d)

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Total cholesterol 4.5-7.5 mmol/l)
  • Age 18-75 years

You may not qualify if:

  • Liver, kidney and thyroid dysfunction
  • Unstable coronary disease
  • Inflammatory bowel disease
  • Medication for hypercholesterolemia
  • Plant stanol/sterol enriched foods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of kuopio

Kuopio, 70211, Finland

Location

Related Publications (2)

  • Hallikainen M, Simonen P, Gylling H. Cholesterol metabolism and serum non-cholesterol sterols: summary of 13 plant stanol ester interventions. Lipids Health Dis. 2014 Apr 27;13:72. doi: 10.1186/1476-511X-13-72.

    PMID: 24766766DERIVED

  • Gylling H, Hallikainen M, Nissinen MJ, Miettinen TA. The effect of a very high daily plant stanol ester intake on serum lipids, carotenoids, and fat-soluble vitamins. Clin Nutr. 2010 Feb;29(1):112-8. doi: 10.1016/j.clnu.2009.08.005. Epub 2009 Aug 26.

    PMID: 19709787DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior scientist

Study Record Dates

First Submitted

June 12, 2008

First Posted

June 17, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2008

Study Completion

December 1, 2008

Last Updated

April 17, 2012

Record last verified: 2012-04

Locations

FI(1)