Effect of High Stanol Ester Dose on Serum Lipids, Carotenoids and Fat-soluble Vitamins (maxsta)

This study has been completed.

Sponsor:

Collaborator:

Raisio Plc.

Information provided by (Responsible Party):

Marjukka Kolehmainen, University of Eastern Finland

ClinicalTrials.gov Identifier:

NCT00698256

First received: June 12, 2008

Last updated: April 16, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 12, 2008
Last Updated Date	April 16, 2012
Start Date ^ICMJE	February 2008
Primary Completion Date	May 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 16, 2008)	Serum lipids, Serum fat soluble vitamins and carotenoids, squalene and non-cholesterol sterols [ Time Frame: baseline, at weeks 9, 10 and 14 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00698256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of High Stanol Ester Dose on Serum Lipids, Carotenoids and Fat-soluble Vitamins
Official Title ^ICMJE	Effect of High Stanol Ester Dose on Serum Lipids, Carotenoids and Fat-soluble Vitamins
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.
Detailed Description	Several studies have shown that 2-3 g of plant stanols as stanol esters reduce serum total and LDL cholesterol concentrations by 10-15%. There are only a few studies in which cholesterol-lowering effects of plant stanols have been studied with higher doses than that. In these studies with the stanol dose of 4 g/d no additional cholesterol-lowering effect has been reached. However, it would be interesting to know, how effective plant stanols are, if a dose is very high, or whether there is really a threshold effect in inhibition of cholesterol absorption. Plant sterols and stanols have been found to reduce serum β-carotene concentrations. Although they have not been shown to affect serum vitamin A concentrations, a concern has been aroused about safety of high doses of plant sterol and stanols. This is not unjustified, because the number of plant sterol and stanol containing products on the market continues to expand, and therefore, it is possible that the daily intake of plant sterols and stanols can rise very high. In humans, the metabolism of plant sterols and stanols is not completely known. Recently, we showed that plant sterols are esterified in enterocytes as well as cholesterol facilitating their transport in lipoproteins. However, it is not known, how consumption of high doses of stanol esters affect the metabolism of plant sterols in enterocytes and their transport. This is important to know, when new foodstuffs enriched with plant sterols or stanols for cholesterol-lowering are developed. In this study, 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. Altogether 50 subjects with normo- or hypercholesterolemia (total cholesterol 4.5-7.5 mmol/l) were recruited to the study from an announcement in the local newspaper. The study is carried out with a randomized, double-blind and parallel design. The intervention group (n=25) consumes spread and oat drink enriched with plant stanol esters (9 g/d stanols) and the control group (n=25) the same product containing no added stanols for 10 weeks. The fasting blood samples are taken at weeks 0, 9, 10 and 14 (4 weeks after the end of the test product consumption). At week 10, an oral postprandial test is performed in 40 subjects in order to study the postprandial metabolism of plant sterols. From blood samples blood count and levels of serum liver enzymes (0 and 10 wk), concentrations of serum lipids, squalene and non-cholesterol sterols, α and β carotenoids, fat soluble vitamins A, E and D (0, 9 and 10 wk) and serum squalene and non-cholesterol sterols (14 wk) will be analyzed.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care
Condition ^ICMJE	Hypercholesterolemia
Intervention ^ICMJE	Dietary Supplement: vegetable oil-based spread and oat-based drink (no brand name available) spread and drink (9 g stanols/d) Dietary Supplement: vegetable oil-based spread and oat-based drink (no brand name available) Spread and drink (not containing added stanols)
Study Arm (s)	Experimental: 1 Intervention: Dietary Supplement: vegetable oil-based spread and oat-based drink (no brand name available) Placebo Comparator: 2 Intervention: Dietary Supplement: vegetable oil-based spread and oat-based drink (no brand name available)
Publications *	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. Epub 2009 Aug 26.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	50
Completion Date	December 2008
Primary Completion Date	May 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Total cholesterol 4.5-7.5 mmol/l) Age 18-75 years Exclusion Criteria: Liver, kidney and thyroid dysfunction Unstable coronary disease Inflammatory bowel disease Medication for hypercholesterolemia Plant stanol/sterol enriched foods
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Finland

Administrative Information
NCT Number ^ICMJE	NCT00698256
Other Study ID Numbers ^ICMJE	132\\2007
Has Data Monitoring Committee	No
Responsible Party	Marjukka Kolehmainen, University of Eastern Finland
Study Sponsor ^ICMJE	Marjukka Kolehmainen
Collaborators ^ICMJE	Raisio Plc.
Investigators ^ICMJE	Not Provided
Information Provided By	University of Eastern Finland
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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