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
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of High Stanol Ester Dose on Serum Lipids, Carotenoids and Fat-soluble Vitamins

Resource links provided by NLM:


Further study details as provided by University of Eastern Finland:

Primary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: February 2008
Study Completion Date: December 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: vegetable oil-based spread and oat-based drink (no brand name available)
spread and drink (9 g stanols/d)
Placebo Comparator: 2 Dietary Supplement: vegetable oil-based spread and oat-based drink (no brand name available)
Spread and drink (not containing added stanols)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698256

Locations
Finland
University of kuopio
Kuopio, Finland, 70211
Sponsors and Collaborators
Marjukka Kolehmainen
Raisio Plc.
  More Information

No publications provided by University of Eastern Finland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marjukka Kolehmainen, Senior scientist, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT00698256     History of Changes
Other Study ID Numbers: 132\\2007
Study First Received: June 12, 2008
Last Updated: April 16, 2012
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Carotenoids
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 28, 2014