The two studies were commissioned by Raisio, the Finnish company that manufactures both Benecol stanol ingredients and Benecol branded end-products such as spreads and yoghurts, to determine the safety of the ingredient at high doses.
While they found this was the case, they were surprised to find that dosages up to 9g per day administered to humans over four weeks in one trial and ten in the other, also reduced cholesterol levels at greater than expected doses.
The studies were presented in June at the 15th International Symposium on Atherosclerosis in Boston, Massachusetts, and were in the process of being peer reviewed, research and development director of the Ingredients Division at Raisio Group, Ingmar Wester, said.
“We wanted to find out if there were any adverse effects above 3g which there weren’t but we were surprised by the finding s because of the enhanced cholesterol-lowering effects in both studies,” he told NutraIngredients-USA.com.
Raisio is analysing the data to determine optimum levels at which stanols can positively affect cholesterol levels, which remain within the scope of commercial viability.
Product testing has indicated levels of up to 6g are viable but European Union regulations would have to change to allow such products to reach market – at least those that can make cholesterol-lowering health claims.
“We hope these studies will affect regulatory thinking,” Wester said. “The current limits retard development of business and a change could allow for additional food products across the EU.”
The studies were conducted in Finland and the Netherlands and examined the effects of a daily dose of up to 9g of plant stanols administered to 93 participants with raised cholesterol levels.
The Dutch study was conducted at the Maastricht University in the Netherlands, and participants consumed yoghurts and spreads fortified with plant stanol ester at levels of three, six or nine grams per day for four weeks.
A control group consumed similar products that were not fortified.
The Finnish study involved 50 people given an oat drink and spread fortified with plant stanol ester at 9g for ten weeks.
The lead researcher of the Finnish study, Professor Helena Gylling, said of the results:
"Now it has been shown that plant stanol ester’s effect in preventing the absorption of cholesterol and thus also its effect of reducing blood cholesterol level are boosted with larger doses of plant stanol. Compared to a daily dose of 2-3 grams of plant stanols, a larger dose of plant stanol is still just as safe."
The current recommended daily dose in the EU is 2g per day, a level that has won a cholesterol-lowering health claim for Benecol in the EU. Unilever won a similar claim for its plant sterol-imbued Pro-activ cholesterol-lowering range.
XV ISA Congress in Boston
‘Very high plant stanol ester intake and serum lipids, sterols, liver function tests, carotenoids, and fat soluble vitamins’
Authors: Gylling et al
‘Dietary plant stanols dose-dependently decrease LDL-cholesterol - but not cholesterol-standardized carotene - at intakes up to 9 g a day’
Authors: Mensink et al