Dicentra Newsletter – Issue #11

October 7, 2010 By

Recent Changes: NHPD Ingredients Database and Ingredient Issue Forms

The NHPD introduced the Natural Health Products Ingredients Database earlier this year. At present, the database contains:

  • Medicinal ingredients
  • Non-medicinal ingredients
  • Non-Natural Health Product (NHP) ingredients (not allowed as medicinal ingredients in natural health products or under specific restrictions)
  • Selected single-ingredient NHPD monographs and selected single-ingredient abbreviated labelling standards (AbLS)
  • Ingredient details relevant to their type (for example, Chemical Abstracts Service (CAS) numbers for chemical substances, organism parts and preparations for organism substances, etc.)
  • Medicinal, non-medicinal, and non-NHP ingredient restriction details
  • Controlled vocabularies that represent a standard for the electronic transmission of core sets of natural health product information (e.g. lists for dosage forms, route of administrations, ingredient categories, organism parts, organism preparations, non-medicinal purposes, etc.).

Applicants may request changes to information already present in the ingredients database, such as request to add a non-medicinal ingredient to the database. In order to add an ingredient, the applicant must file an ingredient issue form. Since the adoption of the Application Management Policy in August 2010, all ingredients, both medicinal and non-medicinal, must be present in the NHPD ingredients database before a PLA can be submitted to the NHPD. The NHPD has set an internal target of 4 weeks to assess and determine whether a potential ingredient will be accepted into the database.

For new applications, the filing and approval of ingredient issue forms means that it will take longer to recieve a submission number for a product. Based on the NHPD’s targets, if your product requires the filing of an ingredient issue form, it is estimated that it will take appromimately 68 days to recieve a submission number (28 days to approve the ingredient issue form + 40 days to recieve a submission number once the application is submitted = 68 calendar days). It is also important to note that filing an ingredient issue form does not mean that the ingredient will be approved. Non-medicinal ingredients may be rejected based on safety concerns, or may take longer than the estimated 4 weeks to be approved.

Health Canada Responds to BMJ Calcium Meta-Analysis

A recent meta-analysis published in the British Medical Journal has reported an association between the use of calcium supplements (without vitamin D) and the increased occurrence of myocardial infarctions. Health Canada has reviewed this study and has determined that the study does not provide conclusive evidence to state that calcium supplementation is associated with increased risk for myocardial infarctions. Health Canada will continue to evaluate data regarding this matter as it is published. As it stands, calcium is recognized as important for helping in the development and maintenance of bones and teeth, especially in children, teens and young adults. Adequate calcium (and vitamin D, which aids in the absorption of calcium) throughout life, through diet and/or supplements, may help prevent bone loss and may reduce the risk of developing osteoporosis in later life. Calcium (in combination with vitamin D) is also used as treatment for osteoporosis. Health Canada also provides recommended daily doses for calcium and advises that calcium supplementation alone should not exceed 1500 mg daily.

For more information visit Health Canada.

Science and Research Updates

Beavers DP, Beavers KM, Miller M, Stamey J, Messina MJ. Exposure to isoflavone-containing soy products and endothelial function: A Bayesian meta-analysis of randomized controlled trials. Nutr Metab Cardiovasc Dis. 2010 Aug 14. [Epub ahead of print]

Cardiovascular disease (CVD) is a leading cause of death, affecting at least 1 in 3 Americans during their lifetime. Impairment of the endothelium represents an early stage of this process and serves as predictive marker of long term cardiovascular morbidity. Associated with the increase in CVD prevalence is an increase in serum cholesterol levels. Soyfoods have been extensively studied for their abilities to reduce cholesterol levels. Soy is a rich source of isoflavones, or phytoestrogens, and phytoestrogen treatment has been shown to improve endothelial function in postmenopausal women. In this study, a Bayesian meta-analysis was conducted to estimate the effects of isoflavone-containing soy protein (ICSP) and soy isoflavones on flow-mediated dilatation (FMD), an indirect measure of endothelial function. The meta-analysis included randomized controlled trials returned following a Pubmed search for “soy”, “isoflavone”, “phytoestrogen”, “EF”, “flow mediated vasodilation” and “FMD”. All trials included in the meta-analysis had a duration of treatment of 4 weeks or more. The literature search returned 17 applicable clinical trials assessing a combined total of 1281 participants in which endothelial function was measured using FMD. The soy isoflavones produced a 2-fold increase on FMD (Bayesian score of 1.98%) when compared with ICSP (Bayesian score of 1.15%). Bayesian scores within the range of 1.5%-2% are deemed to be clinically significant, whereas lower scores are not. Therefore, the results of this meta-analysis indicate that consumption of isolated soy isoflavones confer a benefit to cardiovascular health.

Huang SC, Wei JC, Wu DJ, Huang YC. Vitamin B(6) supplementation improves pro-inflammatory responses in patients with rheumatoid arthritis. Eur J Clin

Nutr. 2010 Sep;64(9):1007-13.

Rheumatoid arthritis (RA) is a chronic autoimmune and systemic inflammatory disease that causes progressive joint destruction. Individuals with RA experience higher mortality rates when compared with the general population. Previous studies have indicated that lower plasma pyridoxal 5′-phosphate (PLP) is associated with increased levels of pro-inflammatory cytokines, e.g. tumor necrosis factor(TNF-α) and inflammatory markers, e.g. C-reactive protein (CRP). Additionally, studies have shown that patients with RA had lower circulating levels of PLP when compared to healthy controls. Therefore, the hypothesis of this study was that a high dose of vitamin B6 (100 mg/day) for 12 week would decrease the inflammatory responses of patients with RA. A single-blind, co-intervention study was conducted to assess the inflammatory and immune responses in patients suffering from RA following supplementation with 100 mg vitamin B6 daily for 12 weeks. All patients were supplemented with an additional 5 mg folate to compensate for the folate-depleting effects of methotrexate, a disease-modifying anti-rheumatic drug taken concurrently by 74% of the participants. Total vitamin B6 and folate intakes significantly correlated with plasma PLP and serum folate levels, respectively. At baseline there were no significant differences in inflammatory and cytokine markers between the control and vitamin B6 groups. High doses of vitamin B6 inversely correlated with pro-inflammatory cytokine levels (i.e. interleukin-6 (IL-6) and TNF-α) following high dose of vitamin B6 supplementation. Additionally, plasma PLP positively correlated with the percentage of total lymphocytes after adjusting for serum folate concentrations. In conclusion, high doses of vitamin B6 was associated with a decrease in pro-inflammatory cytokine levels suggesting that vitamin B6 supplementation may have beneficial effects on RA-associated inflammation.

Lemke SL, Vicini JL, Su H, Goldstein DA, Nemeth MA, Krul ES, Harris WS.

Dietary intake of stearidonic acid-enriched soybean oil increases the omega-3 index: randomized, double-blind clinical study of efficacy and safety. Am J Clin

Nutr. 2010 Aug 25. [Epub ahead of print].

The benefits of omega-3 (n-3) long chain polyunsaturated fatty acids (LCPUFAs), eicosapentaenoic (EPA) and docoshexaenoic acids (DHA) in reducing cardiovascular disease (CVD) are supported in the literature. To recieve these benefits, the American Heart Association (AHA) recommends that individuals eat a variety of fatty fish at least twice a week, and even often more for those suffering from CVD. The most common land-based n-3 fatty acid is α-linoleic acid (ALA), but its conversion rate to EPA in vivo is exceedingly low. Stearidonic acid (SDA) is the product of the rate-limiting step in the synthesis of EPA from ALA and thus is more readily converted to EPA than ALA is. Therefore, the present double-blind study aimed to compare the effect of SDA-enriched soybean oil with that of EPA and soybean oil on the omega-3 index over a 12 week period. Additionally, secondary endpoints measured include: serum triglycerides, total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, systolic blood pressure, diastolic blood pressure, heart rate, high sensitivity C-reactive protein (Hs-CRP), adiponectin and EPA, DHA and SDA as percentages of total lipids in the red blood cell membrane. Two hundred and fifty-two healthy individuals randomly received soybean oil only (control), 1 g EPA with soybean oil or soybean oil enriched with 4.2 g SDA each day. Treatment with EPA and SDA resulted in a higher omega-3 index when compared to the placebo-controlled group and no differences observed between the EPA and SDA groups. The higher omega-3 index was a result of the increase in EPA levels within the red blood cell membrane. No significant changes were observed in any of the additional secondary endpoints. As for safety assessment, no SDA-specific adverse reactions were observed. In cloncusion, the results of this study suggest that SDA as effective as EPA in increasing tissue EPA levels.

Yen CH, Tseng YH, Kuo YW, Lee MC, Chen HL. Long-term supplementation ofisomalto-oligosaccharides improved colonic microflora profile, bowel function,and blood cholesterol levels in constipated elderly people-A placebo-controlled, diet-controlled trial. Nutrition. 2010 Jul 10. [Epub ahead of print].

Impaired bowel function, particularly constipation, is a common complaint of ill or inactive elderly people. Populations with poor chewing ability need suitable dietary fibre which can easily be incorporated into their ordinary diet to maintain regular bowel movements. Isomalto-oligosaccharides (IOs) exist naturally in Japanese foods such as miso and soy sauce. IOs are commercially produced from corn starch as a functional food ingredient. The aim of this double-blind, placebo-controlled study was to evaluate the effects IO on fecal microflora, bowel function and fecal short chain fatty acids in constipated elderly subjects over an 8 week period. Subjects consumed an afternoon drink containing 5 g of IO for the first 4 weeks which was gradually increased to provide 10 g IO daily for the last 4 weeks of the study. Additionally, all participants consumed an identical diet throughout the study. Supplementation with 5 and 10 g IO resulted in significant increases in fecal counts of bifidobacteria, lactobacilli, bacteriodes and total bacteria. Moreover, following supplementation, the fecal clostridia content decreased significantly when compared to pacebo-control. The number of spontaneous bowel movements and amount of stool output were significantly increased following supplementation with 10 g IO daily, but this increase was not observed post-treatment. Additionally, the daily outputs of total short chain fatty acids significantly increased following supplementation with IO when compared to placebo-control. In conclusion, supplementation with IO improved bowel function and promoted the growth of health gut microflora, while decreasing the growth of harmful bacteria, i.e. clostridia. Clostridia are pathogenic to humans and decreasing the amount of this type of bacteria from the bowel may help protect from illness. Overall, supplementation with IO functioned as prebiotic to stimulate to growth of healthy gut bacteria while reducing the presence of pathogenic types of bacteria in the bowels of elderly people.

Thank you for reading, if you have any comments or questions, we can be reached at 1-866-647-3279 or at dicentra.com


Ashleigh Hampton