Effect of High Stanol Ester Dose on Serum Lipids, Carotenoids and Fat-soluble Vitamins
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

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.
    

Intervention name(s): vegetable oil-based spread and oat-based drink (no brand name available); vegetable oil-based spread and oat-based drink (no brand name available)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): spread and drink (9 g stanols/d); Spread and drink (not containing added stanols)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care