With ten years of work behind it, two clinical trials (plus results of a third ready for publication), and Groupe Danone on-board, Canada’s Micropharma is rolling out its cholesterol-lowering Lactobacillus reuteri NCIMB 30242 for the US supplement, food and beverage industries.
Data from the latest trial to be published indicates that nine weeks of supplementation with L. reuteri NCIMB 30242 may reduce cholesterol levels by almost 12%.
“This is the first probiotic in the world to move a recognized marker of disease,” Dr Mitchell Jones, the company’s Chief Scientific Officer, told us.
Micropharma is a family affair, with Dr Jones’ identical twin Ryan sitting in the CEO chair. The company entered a partnership with The Winning Combination Inc. (TWC) to release the first Cardioviva-branded supplements in Canada in late 2012.
The supplements are moving south of the border and will be available in 9,500 Walgreens in the US from May 15, 2013, said Ryan Jones.
The ingredient is also available to food and supplement manufacturers to offer their own branded products, and Micropharma has a letter of no objection from the US Food & Drug Administration (FDA) for the GRAS (generally recognized as safe) status of the strain for use in food and beverages up to a dose of 10 billion CFUs (colony forming units) per serving.
Ryan Jones confirmed the company is already working with a number of multinational food companies on formulations containing L. reuteri NCIMB 30242. The Quebec-based company is already well connected in that area: French dairy giant Groupe Danone owns 22%.
The interest in the ingredient is understandable, given the impressive results from double-blind, placebo-controlled, randomized human trials. The first, published in the British Journal of Nutrition (2012, Vol. 107, pp. 1505-1513), found that a yogurt formulation containing the company’s microencapsulated bile salt hydrolase (BSH)-active L. reuteri NCIMB 30242 could reduce LDL cholesterol by about 9% and total cholesterol by about 5% over six weeks.
“The efficacy of microencapsulated BSH-active L. reuteri NCIMB 30242 yoghurts appears to be superior to traditional probiotic therapy and akin to that of other cholesterol-lowering ingredients,” concluded Dr Jones and his co-workers.
This was followed by a nine week study, published in the European Journal of Clinical Nutrition (2012, Vol. 66, pp. 1234-1241), which found that L. reuteri NCIMB 30242 capsules could reduce LDL and total cholesterol by 11.6% and 9.1%, respectively, in people with elevated cholesterol levels.
Such reductions put the probiotic firmly in the range of the cholesterol-reduction market’s established leaders – the phytosterols and stanols, with clinical data indicating that daily consumption of 1.5 to 3 grams of phytosterols/-stanols from foods can reduce total cholesterol levels by 8-17%.
“We know from our research that 3 out of 4 supplement users are eager for a natural solution between diet, exercise and drugs to manage their cholesterol,” said Ryan Jones.
High cholesterol levels, hypercholesterolemia, have a long association with many diseases, particularly cardiovascular disease (CVD), the cause of almost 50 per cent of deaths in Europe and the US.
A report from the American Heart Association predicted a tripling of direct medical costs of cardiovascular disease from $272.5 billion to $818.1 billion between 2010 and 2030 (Circulation, March 2011, Vol. 123, pp. 933-944).
“Cardioviva is a very different product than a plant sterol – it is a probiotic that lowers cholesterol in two ways: by reducing the amount of cholesterol your body produces, and by reducing the amount absorbed from food,” he added.
The EJCN paper also indicated that the probiotic capsules may reduce other cardiovascular risk factors, including fibrinogen and high sensitivity C-reactive protein (hs-CRP).