The study, published in The Journal of Clinical Endocrinology & Metabolism, is the first to show that oral probiotic supplements may increase circulating levels of the sunshine vitamin.
“This study, part of an ongoing line of research in bile metabolism and Western disease, is adding to the body of knowledge on the microbiome and its role in human health,” explained Mitchell Jones MD, PhD, lead study author and chief scientific officer, Micropharma Limited.
“Although it has long been known that the gastrointestinal tract plays an active role in the absorption of vitamin D, these findings showing improved vitamin D status in response to an orally delivered probiotic are a first, and will inform the development of new products that may be beneficial for people with low vitamin D levels.”
Data on D
Vitamin D refers to two biologically inactive precursors - D3, also known as cholecalciferol, and D2, also known as ergocalciferol.
Both D3 and D2 precursors are transformed in the liver and kidneys into 25- hydroxyvitamin D (25(OH)D), the non-active 'storage' form, and 1,25-dihydroxyvitamin D (1,25(OH)2D), the biologically active form that is tightly controlled by the body.
Vitamin D deficiency, which is defined as a status of less than 20 nanograms per milliliter (ng/mL) of 25-(OH)D, can cause a number of health issues, including rickets and other musculoskeletal diseases.
Recently, however, data suggests that vitamin D deficiency (<20 ng/mL) and vitamin D insufficiency (between 21-29 ng/mL) may be linked to cancer, autoimmune diseases, infectious diseases, type 2 diabetes and cardiovascular disease.
Market growth for vitamin D
As the potential health benefits of the vitamin have increased, consumer awareness and understanding has also increased. Indeed, Consumer surveys regularly show vitamin D among the top five most popular supplements, after multivitamins and fish oil/omega-3.
“The vitamin D market has grown by 20% a year over the last 10 years, and within this timeframe, U.S. medical costs around osteoporosis and fractures in an aging population were already estimated at $22 billion ,” said Ryan Jones, Micropharma’s CEO.
“As a pioneer in research and innovation on products that work naturally through the microbiome to impact health outcomes, we are very encouraged about the potential for these vitamin D findings for public health.”
Study details
Dr Jones and his co-workers analyzed data from a double-blind, placebo-controlled, randomized, parallel-arm, multi-center trial involving 127 otherwise healthy adults with elevated cholesterol levels. Participants were randomly assigned to take either the placebo or the probiotic L. reuteri NCIMB 30242 for nine weeks.
Results indicated a significant increase in 25(OH)D levels over the nine weeks of 14.9 nmol/l or 25.5%. This was a significant change relative to placebo of 22.4%, they added.
Dr Jones told NutraIngredients-USA that there are no animal data on the effects of L. reuteri NCIMB 30242 on circulating 25 hydroxyvitamin D.
“We evaluated the levels of vitamin A, D, E and beta-carotene in this study to determine the effects of reduced sterol absorption on the absorption of the fat soluble vitamins," he said.
“To our surprise there were no differences between placebo and treated groups except for in the active form of vitamin D (25 hydroxyvitamin D).
“In retrospect there are reports of reduced intestinal pH (a result of lactic acid production) resulting in increased vitamin D absorption and 7-DHC is a common precursor to both cholesterol and vitamin D. Increased plasma deconjugated bile acids and reduced plasma non-cholesterol sterols campesterol, sitosterol, and stigmasterol suggest an effect on sterol absorption and a novel cholesterol reducing mechanism of action.
“The observation of significantly increased 25(OH)D despite no between group differences in dietary intake or seasonality of the intervention period is significant, as to our knowledge this is the first report of fat soluble vitamin status in response to a BSH-active probiotic and the first report of increased levels of circulating 25(OH)D in response to oral supplementation with any probiotic.
“In short, we believe it is possible that more vitamin D is being absorbed or that more precursor is being synthesized,” he said.
Dr Jones added that it is highly likely that delivery of the strain and vitamin D together would result in greater increases, but this is yet to be shown.
Cholesterol reduction
Micropharma, which is part owned by French dairy giant Groupe Danone (22%), has already published compelling data for the strain’s cholesterol-lowering activity.
The most recent study, a nine week intervention publishing in the European Journal of Clinical Nutrition (2012, Vol. 66, pp. 1234-1241), 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.
The company entered a partnership with The Winning Combination Inc. (TWC) to release the first Cardioviva-branded supplements in Canada in late 2012.
Dr Jones added: “Micropharma’s probiotic strain, and the ingredient name, is L. reuteri NCIMB 30242 (which we are short forming to “LRC”). Cardioviva is a brand name and is positioned as a probiotic supplement shown to maintain cholesterol levels. Because these are natural health products the consumer messaging, understanding, use, and potential outcomes have to be clearly communicated; we feel they are with Cardioviva.
“Micropharma is looking at other indications for our ingredient L. reuteri NCIMB 30242 and we plan to launch other products for these indications in the future. These products may contain L. reuteri NCIMB 30242 alone or be reformulated with additional ingredients. These future brands will carry their own trade name and will be positioned to consumers for their various indications so that the consumer is clear of the message of the natural product, its action, and outcomes.
“It has always been the intention of Micropharma to launch a number of products of different indications that work to improve metabolic and chronic disease states through the microbiome and better bile metabolism and in a natural way and we continue to work toward this goal.”
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.
Source: The Journal of Clinical Endocrinology & Metabolism
Published online ahead of print, doi:10.1210/jc.2012-4262
“Oral supplementation with probiotic L. reuteri NCIMB 30242 increases mean circulating 25-hydroxyvitamin D: a post-hoc analysis of a randomized controlled trial”
Authors: M.L. Jones, C.J. Martoni, S. Prakash