Consumption of Flavanol-Containing Cocoa Reverses Vascular Dysfunction in Diabetic Patients

Balzer J, Rassaf T, Heiss C, et al. Sustained benefits in vascular function through flavanol-containing cocoa in medicated diabetic patients: a double-masked, randomized, controlled trial. J Am Coll Cardiol. 2008;51(22): 2141-2149.

The prevalence of type 2 diabetes mellitus is increasing worldwide and is accompanied by an increasing risk of cardiovascular disease and mortality. Prescription medications are often used extensively in an attempt to prevent and/or treat complications of type 2 diabetes; however, they are often inadequate. Observational studies have shown that lifestyle modification (e.g., increased physical activity, weight loss, and dietary changes) can prevent diabetes and its associated complications. Epidemiologic studies have recently shown an inverse correlation between flavanol consumption and mortality from cardiovascular disease and the incidence of diabetes. Flavanols are predominantly found in fruit, vegetables, tea (Camellia sinensis), red wine (Vitis vinifera), and especially cocoa (Theobroma cacao). The results of dietary intervention trials have shown beneficial effects of flavanols on low-density-lipoprotein (LDL) oxidation, platelet aggregation, insulin sensitivity, endothelial function, and blood pressure. The objective of the present study was to investigate the feasibility and efficacy of a dietary intervention with flavanols from cocoa on improving vascular function in diabetic patients.

Men and women aged 50-80 years on hypoglycemic medication with a history of stably treated type 2 diabetes for at least 5 years were screened for eligibility. Ten patients were enrolled in a feasibility study, and 41 patients were enrolled in an efficacy study. Both studies had a randomized, double-masked design. In the feasibility study, the subjects consumed a single cocoa drink providing 75 mg (control), 371 mg (medium content), or 963 mg (high content) flavanols on 3 separate occasions (crossover design). Flow-mediated dilation (FMD), a measure of endothelial function, was measured an hour before and 1, 2, 3, 4, and 6 hours after ingestion of the cocoa drink. Blood samples were collected 2 hours after ingestion for the measurement of plasma flavanol concentrations. In the efficacy study, the subjects consumed 3 doses daily of either 321 mg flavanols (treatment group; 963 g/day total) or 25 mg of flavanols (control group; 75 mg/day total) for 30 days. FMD, blood pressure, heart rate, clinical variables, and plasma flavanol metabolites were measured at baseline and again on the same day 2 hours after ingestion of the day’s first amount of cocoa on days 0, 8, and 30. The cocoa drinks were prepared from a dry cocoa beverage mix (made using CocoaPro® cocoa powder; Mars Inc.; Hackettstown, New Jersey), and all of the cocoa drinks were similar in other macro- and micro-nutrient, caloric and alkaloid content, taste, and appearance. The primary outcome measure was endothelial function, which was determined on the basis of FMD of the brachial artery. Secondary outcome measures included changes in plasma flavanol metabolites 2 hours after ingestion of cocoa, blood pressure, and fasting plasma glucose, plasma lipid, and glycated hemoglobin concentrations.

In the feasibility study, the mean FMD of the study population was 3.8 ± 0.3%. A dose-dependent increase in FMD was observed after consumption of 371 and 963 mg flavanols, but not after ingestion of 75 mg flavanols (control). The highest FMD (5.5 ± 0.4%; P < 0.001 compared with baseline) occurred 2 hours after ingestion of the highest flavanol intake (963 mg). Plasma flavanols and FMD increased significantly in all of the subjects who ingested 963 mg flavanols. In the efficacy study, fasting FMD in the treatment group increased significantly from 3.3 ± 1.1% at baseline to 4.1 ± 1.1% on day 8 (P < 0.001) and to 4.3 ± 1.2% on day 30 (P < 0.0001). Significant acute-on-chronic increases (increases after consumption of the day's first amount) in FMD after flavanols ingested continued throughout the duration of the study (P < 0.0001). Plasma flavanol metabolites did not increase significantly in the control group but did increase significantly in the treatment group, from 1473.2 ± 670.9 nmol/L at baseline to 2177.7 ± 995.1 nmol/L (P = 0.0027) on day 30. No significant changes in blood pressure or in fasting plasma glucose and plasma lipid concentrations were observed in either the treatment or the control group on day 30, except for a significant decrease (P = 0.0063) in the LDL concentration in the treatment group. Glycated hemoglobin on day 30 was significantly lower than that at baseline in both the treatment (P = 0.0480) and control (P = 0.0038) groups. The authors conclude that their study "clearly establishes improvements of endothelial function after regular consumption of flavanol-containing cocoa in patients with type 2 diabetes." Flavanol consumption was well tolerated with no evidence of tachyphylaxia (desensitization to the treatment). The findings indicate the therapeutic potential of flavanols for helping reduce the risk of cardiovascular disease in type 2 diabetics on medication. —Brenda Milot, ELS American Botanical Council, 6200 Manor Rd, Austin, TX 78723

Vitamin D and intervention trials in prostate cancer: from theory to therapy.

Schwartz GG.

Departments of Cancer Biology and Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, NC, USA. gschwart@wfubmc.edu

Studies of vitamin D and prostate cancer have advanced rapidly from the hypothesis that vitamin D deficiency increases the risk of prostate cancer to intervention trials of vitamin D administration in clinical cancer. The hormonal form of vitamin D, 1,25(OH)(2)D, exerts prodifferentiating, antiproliferative, anti-invasive, and antimetastatic effects on prostate cells. Moreover, normal prostate cells synthesize 1,25(OH)(2)D from serum levels of the prohormone, 25-hydroxyvitamin D. The autocrine synthesis of 1,25(OH)(2)D by prostatic cells provides a biochemical mechanism whereby vitamin D may prevent prostate cancer. Many prostate cancer cells have lost the ability to synthesize 1,25(OH)(2)D but still possess 1,25(OH)(2)D receptors. This suggests that whereas vitamin D (e.g., cholecalciferol) might prevent prostate cancer, existing prostate tumors likely would require treatment with 1,25(OH)(2)D and/or its analogs. The major obstacle to the use of 1,25(OH)(2)D in patients therapeutically is the risk of hypercalcemia. Several maneuvers to reduce this risk, including pulse dosing and the use of less calcemic 1,25(OH)(2)D analogs, have been explored in Phase I-III clinical trials. Once merely a promise, vitamin D-based therapies for prostate cancer may soon be medical practice.

PMID: 18619854 [PubMed – indexed for MEDLINE]

ABC Responds to Article on Herb-Drug Interactions in Journal of the American College of Cardiology

(Austin, TX) At least several times per year an article is published in a medical journal that purports to provide health professionals and the public with useful information on the safety of herbs and herbal dietary supplements. Instead, what sometimes occurs is an article written by people with apparently little to no expertise in the subject area of herbal medicine and medicinal plant research and likewise apparently peer reviewed—if peer reviewed at all—by reviewers with little botanical knowledge or expertise. Yesterday, the Journal of the American College of Cardiology published such an article.1

This particular article has so many flaws and errors that it is difficult to know where to begin to critically review it.

First, Latin names for the herbs discussed are missing, a disservice to any readers who may not be familiar with common names used in the United States.

Second, some of the tables in the article contain entries for “commonly used herbs,” which include the toxic plant oleander (Nerium oleander, a toxic herb with cardioactive glycosides not sold to consumers in the US dietary supplement market); chan su (presumably dried Chinese toad venom—not an herb nor generally available as a dietary supplement!); and uzara root (Xysmalobium undulatum), an anti-diarrhea herbal drug approved in Germany. None of these are “commonly” found in the US herbal dietary supplement market.

Grapefruit juice, which is well known for increasing serum levels of many pharmaceutical drugs, is referred to as an herb.

The authors refer to “ginseng” without clarifying which species of the genus Panax they are referring, many of which cause varying pharmacological effects. Also, with respect to “ginseng,” the authors unfortunately repeat the highly erroneous adverse effect information from the widely discredited 1979 uncontrolled study by RK Siegel on the “Ginseng Abuse Syndrome,” stating that “ginseng” can cause “hypertension, behavioral changes and diarrhea.”

Capsicum is listed in a table as being used for shingles, trigeminal, and diabetic neuralgia, when it is actually the US Food and Drug Administration-approved over-the-counter and prescription drug capsaicin, the vanillanoid compound derived from chili peppers (Capsicum spp.), which is used for such purposes.

There are more; the errors and problems in this paper are too numerous to list completely at this time.

While there are potential and actual interactions that various herbs can have with drugs used by patients with cardiovascular diseases, this paper will do little to improve professional awareness and skill in this area. However, the resulting media coverage will undoubtedly increase public confusion over what is an already confused subject. This paper should not have been published in its present form without serious additional edits, revisions, and deletions, and the Journal of the American College of Cardiology would be advised to retract it.

Reference

Tachjian A, Maria V, Jahangir A. Use of herbal products and potential interactions in patients with cardiovascular diseases. J Amer Coll Cardiol. 2010;55(6). [DOI:10.1016/j.jacc.2009.07.074].

Vitamin D reverses diabetic neuropathy

by Dr Linda Calabresi
15 April 2008

Vitamin D supplementation is an effective treatment of neuropathic pain in Type 2 diabetes patients, new Australian research suggests.

Previous research has found that vitamin D deficiency is common in patients with Type 2 diabetes, but its effect on neuropathic pain has not previously been tested, say study authors Drs Paul Lee and Roger Chen from Concord Repatriation General Hospital.

Their study, published in today’s Archives of Internal Medicine (168:771-772) involved 51 patients with Type 2 diabetes and typical neuropathic pain. All patients were vitamin D deficient with a mean serum 25D concentration of 18 ng/mL.

After three months, vitamin D repletion with cholecalciferol (vitamin D3) tablets resulted in a significant reduction in pain scores using two separate assessments, one suggesting the pain severity was reduced by 40% the other suggesting pain severity had been halved.

How vitamin D reduces the severity of diabetic neuropathic pain is uncertain, but the researchers suggest that vitamin D insufficiency may potentiate diabetic nerve damage and impair nociceptor function. The results could not be explained by a decrease in parathyroid hormone as testing did not show any statistically significant difference in hormone level following the vitamin D repletion, they say.

Vitamin D is known to have a role in the prevention of osteoporosis. It is also increasingly being recognised for its ability to improve glycaemic control, the endocrinologist researchers said. In addition, vitamin D repletion is free of adverse effects.

Therefore, the researchers said they would advocate a trial of vitamin supplementation in vitamin D-deficient patients with neuropathic pain.

“It is unlikely to have any harmful effects and may offer not only pain relief but also beneficial effects on bone health and glycaemic control.”

Source: www.sci.rutgers.edu/forum/showthread

Glycemic Index Education May Lead to Better Diabetes Control

Nine weeks of education about the glycemic index in foods is enough to encourage adults with type 2 diabetes to adopt better dietary habits that result in improvements to their health, suggests recent research published in Public Health Nutrition.

Participants in a clinical trial attended weekly sessions to learn about the potential benefits of low­–glycemic-index foods. After nine weeks, the participants had adopted a lower glycemic-index diet and recorded lower weight, smaller waists, and improved blood sugar levels. When they were tested again another nine weeks later—during which time they received no additional education—the participants had maintained most of those improvements.

The research addresses a controversy in the nutrition community: Some practitioners believe the principles behind maintaining a low–glycemic-index diet are too complicated for average consumers.

“We found that with education, people with diabetes were able to adopt a lower glycemic-index diet. And it had a significant improvement in their weight control and glucose control,” says Carla Miller, senior study author and an associate professor of human nutrition at Ohio State University. “A vast majority of people with diabetes don’t get sufficient education about their condition when they are diagnosed. And yet for many patients, that’s the only time they receive nutrition education. What they really need is continued education and support to help them maintain good control.”

In the study, people with diabetes were randomized to one of two groups. One group immediately participated in the nine-week intervention, and the other group waited for nine weeks before undergoing the same intervention.

The 103 participants who completed the study were between the ages of 40 and 70, had been diagnosed with type 2 diabetes for at least one year, and did not require insulin therapy for diabetes management. For the most part, participants were already doing a good job of controlling their blood glucose levels.

Each group education session lasted between 90 minutes and two hours. Session topics included self-monitoring of food intake and portion sizes, carbohydrate counting, and maintaining behavioral change. Overall, the intervention emphasized selecting lower glycemic-index foods rather than restricting overall carbohydrate intake.

“The emphasis historically has been to control how much carbohydrate people with diabetes eat rather than the type of carbohydrate they choose. And the controversy has been that the glycemic index is so complicated, it’s just another thing that we are asking people to worry about,” Miller says. “And they do have to balance many different variables to get all of these blood parameters under control. That’s another reason they need a lot more education than they receive.”

Researchers collected health measures and diet and physical activity information before and after the intervention period. During the intervention, participants tested their blood glucose levels before and after meals four days per week. To track the participants’ food choices, researchers made periodic unannounced phone calls and asked patients to recall what they had eaten in the previous 24 hours.

After nine weeks of intervention, participants in the first group lost an average of about 5.1 lbs, decreased their waist circumference by 1.1 inches, reduced their body mass index by almost 1 point, and lowered their blood glucose concentration after eating by almost 18 mg/dL. Another nine weeks later, even with no additional intervention, these participants had maintained those health benefits, with the exception of a slight average gain in waist circumference among women.

The participants who waited nine weeks for the intervention recorded similar health improvements after they attended the education sessions. But Miller notes that while they waited, this group also gained weight and recorded expansions of their waists—yet another sign that education can’t start soon enough for many patients with diabetes.

“They had a trajectory of change that was getting worse,” she says. “People with diabetes do need continued support to sustain optimal glycemic control because the disease progresses as they live longer.”

Based on self-reports of food choices, the study showed that participants’ fiber intake improved and they ate less fat. And they did not restrict carbohydrates but instead made different carbohydrate choices.

“We were not putting people on a strict diet. They consumed the same amount of carbohydrate that they normally would but selected lower glycemic-index foods within that carbohydrate allotment,” Miller says. “That addresses another controversy in nutrition. People with diabetes do not have to go on a low-carb diet, which typically is accompanied by a high intake of fat. What these participants ate was closer to [what] the dietary guidelines generally recommend for Americans, with less than 30% of calories coming from fat. The quantity of carbohydrate does matter to some extent, but the type of carbohydrate makes a big difference.”

— Source: The Ohio State University

Source: www.todaysdietitian.com

Anti Oxidant Activity of Tumeric

Turmeric (Curcuma longa) is a major culinary spice of India and other Asian countries, and has been shown to have anti-cancer, anti-coagulative, and anti-hepatotoxic properties. As an anti-oxidant, it is sometimes added (at 0.5-1.0% levels) to ground nut oils to reduce the formation of peroxides and to increase shelf-life. This study was conducted to determine the nature of the anti-oxidant principle in turmeric. From an aqueous extract of powdered turmeric tubers, a heat-stable protein with anti-oxidant properties was isolated. This turmeric anti-oxidant/protein (TAP) was found to inhibit lipid peroxidation in both of the environments in which it was incubated: in vitro in rat brain tissue, and in cod liver oil.

In previous studies, turmeric has been shown to be as effective an anti-oxidant as butylated hydroxy anisole, which is used in the preservation of foods. But whereas high concentrations of butylated hydroxy anisole have been shown to be toxic, high concentrations of turmeric have been reported to be non-toxic. These findings, therefore, are significant in areas where turmeric is consumed in the diet. The ability of TAP to protect tissues from peroxidation merits further study.

January 8. 1996

Selvam, R., Lalitha Subramanian, R. Gayathri, and N. Angayarkanni. The anti-oxidant activity of turmeric (curcuma longa) Journal of Ethnopharmacology. Vol 47, 1995:.

Source: The American Botanical Council

Celiac Disease

Disease characteristics. Celiac disease is a systemic immune disease that can be associated with gastrointestinal findings (diarrhea, weight loss, abdominal pain, anorexia, lactose intolerance, abdominal distention, and irritability) and/or highly variable non-gastrointestinal findings (iron-deficiency anemia, dermatitis herpetiformis, chronic fatigue, joint pain/inflammation, migraines, depression, attention-deficit disorder, epilepsy, osteoporosis/osteopenia, infertility and/or recurrent fetal loss, vitamin deficiencies, short stature, failure to thrive, delayed puberty, dental enamel defects, and autoimmune disorders). Classic celiac disease, characterized by mild to severe gastrointestinal symptoms, is less common than nonclassic celiac disease, characterized by absence of gastrointestinal symptoms.

Diagnosis/testing. The diagnosis of celiac disease relies on characteristic histologic findings on small-bowel biopsy and clinical and/or histologic improvement on a gluten-free diet. Most individuals with celiac disease have celiac disease-associated antibodies and specific pairs of allelic variants in two HLA genes, HLA-DQA1 and HLA-DQB1. Because 30% of the general population has one of the celiac disease-associated HLA alleles and only 3% of individuals with one or both of these alleles develop celiac disease, presence of celiac disease-associated HLA alleles is not diagnostic of celiac disease; however, their absence essentially excludes a diagnosis of celiac disease.

Management. Treatment of manifestations: lifelong adherence to a strict gluten-free diet (avoidance of wheat, rye, and barley); treatment of nutritional deficiencies (iron, zinc, calcium, fat-soluble vitamins, folic acid); standard treatment of osteoporosis. Prevention of primary manifestations: lifelong gluten-free diet. Surveillance: for symptomatic individuals responsive to a gluten-free diet, periodic physical examination and assessment of growth, nutritional status, and non-gastrointestinal disease manifestations; repeat small-bowel biopsy one to three years following diagnosis. For symptomatic individuals unresponsive to a gluten-free diet, periodic evaluation for refractory sprue, ulcerative enteritis, T-cell lymphoma, and other gastrointestinal cancers. Agents/circumstances to avoid: dietary gluten. Testing of relatives at risk: when the celiac disease-associated HLA alleles in the family are known, molecular genetic testing of first-degree relatives (including young children) to monitor those with known celiac disease-susceptibility alleles for early evidence of celiac disease in order to institute gluten-free diet early in the disease course.

Genetic counseling. Celiac disease is a multifactorial disorder resulting from the interaction of HLA-DQA1 and HLA-DQB1 gene variants known to be associated with celiac disease susceptibility, less well-recognized variants in non-HLA genes, gliadin (a subcomponent of gluten), and other environmental factors. Some empiric risk data are available for at-risk relatives.

Diagnosis

Clinical Diagnosis

The diagnosis of celiac disease is made through the combination of the following [Hill et al 2005, NIH Consensus Committee 2005, Green & Cellier 2007]:

· Small-bowel biopsy that shows characteristic histologic abnormalities

· Subsequent improvement (clinical and/or histologic) on a gluten-free diet

· Additional findings in most affected individuals:

· Clinical findings or abnormal laboratory findings (although some individuals are asymptomatic and lack laboratory abnormalities)

· Celiac disease-associated antibodies
Note: Although positive specific antibody testing is highly associated with celiac disease and greatly facilitates its diagnosis [Fasano 2001, Farrell et al 2002], small-bowel biopsy remains the gold standard in confirming the diagnosis of celiac disease.

· Celiac disease-associated human leukocyte antigen (HLA) alleles

Testing

Celiac-associated antibody testing

Note:

(1) It is important for the individual being tested to remain on a gluten-containing diet before celiac disease-associated antibody testing and small-bowel biopsy are performed because antibody levels and histologic abnormalities gradually revert to normal on a gluten-free diet.

(2) For individuals on a gluten-free diet, diagnostic celiac disease-associated antibody testing and small-bowel biopsy should follow a gluten challenge (i.e., eating gluten-containing foods [the equivalent of one to three slices of bread per day] for one to three months and sometimes longer if no symptoms are observed). However, the gluten challenge can make some individuals very ill.

· Tissue transglutaminase (tTG) IgA. Measurement of serum concentration of tissue transglutaminase (tTG) immunoglobulin A (IgA) is often recommended for initial testing because of its high sensitivity and specificity for celiac disease, relatively low cost, and ease of test performance and reliability. However, the sensitivity and specificity differ among laboratories [Abrams et al 2006]. False positive test results may occur in persons with acute coronary syndromes and in individuals with cirrhosis and chronic liver disease.

· Endomysial antibody (EMA) IgA. Serum concentration of endomysial antibody (EMA) IgA has the highest specificity (~99%), but is more expensive and more time-consuming to perform and is potentially more prone to false negative results than serum concentration of tTG IgA. Because it is determined by indirect immunofluorescence, serum concentration of EMA IgA is subject to observer variability, which affects its sensitivity [Murray 2004]. When performed in an experienced laboratory, this test has a higher specificity (approaching 100%) than tTG antibody testing and is useful in individuals with cirrhosis.

· Anti-deamidated gliadin-related peptide (a-DGP) antibodies IgA and IgG. This new test detects antibodies binding synthetic deamidated gliadin-related peptides (DGPs). In preliminary studies examining groups with a high prevalence of celiac disease, both isotypes (IgA and IgG) were shown to be highly sensitive and specific for active celiac disease. Specificity is greater than in antigliadin (AGA) testing and similar to that for tTG testing. An increase in DGP antibody levels may precede an increase in serum concentration of tTG-IgA in young children [Liu et al 2007, Niveloni et al 2007]. However, as in all antibody tests, a minority of individuals have false negative results.

· Measurement of serum concentration of total IgA to evaluate for selective IgA deficiency. The prevalence of selective IgA deficiency, a condition of unknown cause, is 1:700 in the general population. For unknown reasons the prevalence of selective IgA deficiency is higher (1:50) in individuals with celiac disease than in the general population [Wong el al 2003, Alaedini & Green 2005].
Note: Because individuals with selective IgA deficiency do not produce IgA antibodies, the celiac-associated IgA antibodies tTG IgA and EMA IgA are not present in these individuals. Therefore, in these individuals, testing for celiac-associated IgG antibodies (tTG IgG) or DGP-IGG should be performed instead.

· Antigliadin antibody (AGA) IgA and IgG. The NIH Consensus Development Conference on Celiac Disease recommended against the use of AGA in the diagnosis of celiac disease because of the low specificity of this assay and the availability of more specific and sensitive tests, including tTG and EMA IgA [Hill et al 2005].

Note: (1) The overall sensitivity of celiac disease-associated antibody testing may be slightly increased when all four tests (serum concentrations of tTG IgA, EMA IgA, total IgA, and AGA IgA and IgG) are performed. However, the use of panels that incorporate AGA markedly increase the false positive rate as a result of a lone positive AGA antibody and drop the positive predictive value to low levels except in the case of a very high pre-test prevalence. (2) Although a positive result on celiac disease-associated antibody testing is likely to be diagnostic of celiac disease, false positive results occur. (3) Conversely, normal celiac-associated antibody test results do not exclude the diagnosis of celiac disease, especially in the presence of lesser degrees of villous atrophy or in persons on a gluten-free diet prior to testing.

Small-bowel biopsy generally refers to multiple (four or more) biopsies taken endoscopically from the post-bulbar duodenum.

Characteristic histologic findings that are the gold standard for the diagnosis of celiac disease include partial or complete villous atrophy, crypt hyperplasia, and increased intraepithelial lymphocytes (IELs). Based on the dynamic development of the pattern of the intestinal lesions and the frequency of mild lesions in celiac disease, Marsh [1992] proposed a four-stage grading classification to establish the diagnosis and to assess improvement in response to a gluten-free diet (Table 1). Although these changes are not unique to celiac disease, reversion of intestinal damage after gluten withdrawal is unique to celiac disease. The positive predictive nature of the biopsies depends on the relative prevalence of celiac disease as compared to other causes of enteropathy in the population.

Authored by:

Cara L Snyder, MS, CGC

Certified Genetic Counselor
Kimball Genetics, Inc
Denver

Danielle O Young, MS, CGC

Certified Genetic Counselor
Kimball Genetics, Inc
Denver

dyoung@kimballgenetics.com

Peter HR Green, MD

Director, Celiac Disease Center
Professor of Clinical Medicine
Columbia University
New York

pg11@columbia.edu

Annette K Taylor, MS, PhD, FACMG

President and CEO
Kimball Genetics, Inc.
Denver

aktaylor@kimballgenetics.com 03072008celiac
Initial Posting: July 3, 2008.

Source: Gene Reviews; funded by the NIH Developed at the University of Washington, Seattle 1993-2009

Monograph on Scientific and Clinical Research of Pycnogenol®

(Austin, TX) January 21, 2010. The nonprofit American Botanical Council (ABC) has just published a monograph summarizing selected scientific and clinical studies of Pycnogenol^®, a patented dietary ingredient from French maritime pine bark.

Seventeen human clinical studies of Pycnogenol are reviewed in the monograph, evaluating the extract’s potential benefits in numerous areas. These include its cardiovascular benefits, such as its ability to reduce difficulties associated with chronic venous insufficiency and problems related to thrombosis (formation or presence of blood clots in blood vessels).

Based on the review of scientific and clinical trials, the monograph notes that Pycnogenol has been shown to have a wide range of potential applications, including the ability to improve blood sugar control in patients with type 2 diabetes and improve endothelial function (the ability of blood vessels to widen through relaxation of the muscular wall of the vessels). Current clinical trial data suggest that Pycnogenol may also help decrease edema formation (swelling) in the lower legs, benefit children with attention deficit hyperactivity disorder (ADHD), be a useful adjunct therapy for patients with asthma, reduce pain associated with menstrual disorders, and improve subjective symptoms of osteoarthritis in the knee.

“Pycnogenol is an excellent example of a natural plant-based product which is the subject of extensive clinical research,” said ABC Founder and Executive Director Mark Blumenthal. “ABC acknowledges Horphag Research, the manufacturer, for its singular focus and for its commitment to funding continued clinical trials to investigate and document the beneficial role Pycnogenol might have in selfcare and healthcare.”

Horphag Research of Geneva Switzerland invests about $1.5 million annually in new scientific and clinical research on the special extract.

“The ABC monograph on Pycnogenol presents one of the most comprehensive and detailed monographs ever published on a dietary ingredient,” said Victor Ferrari, CEO of Horphag Research. “Consumers, health professionals, and industry members alike are looking for comprehensive and evidence-based information, and as such, the monograph provides an excellent detailed view of the versatility of this natural product.”

The monograph is published in three parts: The full monograph, a clinical overview (i.e., executive summary) containing condensed information from the monograph, and a consumer/patient information sheet, consisting of essential information for consumer education about the responsible use of the product. Each of these elements is accessible separately on the ABC website.

The full monograph contains an overview of Pycnogenol’s production and chemistry, uses of the product, dosage information, summaries of the product’s pharmacology and mechanisms of action, safety data, and summaries of selected clinical trials. A table includes synopses of the clinical trials profiled within the monograph’s text, plus summaries of several additional studies. The monograph also includes how Pycnogenol is regulated in 10 countries and regions around the world.

Pycnogenol’s manufacturer Horphag Research has extensively studied the extract over the past 40 years to assure the safety and efficacy of Pycnogenol as an ingredient in dietary supplements and conventional foods. More than 220 studies and review articles have been published on the extract, and Horphag Research earned the Frost & Sullivan North American Health Ingredients Excellence in Research of the Year Award for 2008.

“Horphag Research has incorporated ongoing research into its business model as a necessity to keep the pledge towards its customers and consumers to rely on scientific evidence,” said Ferrari, explaining that this research will also provide the basis for new product development, patents, and new product applications. “To date, we have not come across any other company performing the same amount of research at the same level of quality on a single ingredient. It is critical to investigate nutritional ingredients to the point that one can establish that they are of the highest quality, safe, and that the data shows supporting scientific evidence for their use.”

ABC’s 19-page monograph on Pycnogenol was written by toxicologist Heather S. Oliff, PhD, and it was formally peer reviewed by scientific and medical experts for its accuracy.

ABC emphasizes that the publication of the Pycnogenol monograph is not an endorsement or recommendation of the ingredient or the manufacturer. “ABC has had a long history of documenting the specific herbal products and ingredients that have been clinically tested,” said Blumenthal. “As part of our nonprofit educational mission, we believe it is in the public interest to identify clinically tested natural plant-based products and ingredients which the scientific literature suggests are safe and beneficial.”

ABC’s Pycnogenol monograph is the fourth in a series of product-specific monographs that the organization has initiated. Additional monographs concerning specific researched commercial products and ingredients are being developed by ABC.

About the American Botanical Council

Founded in 1988, the American Botanical Council is a leading international nonprofit organization addressing research and educational issues regarding herbs and medicinal plants. ABC’s members include academic researchers and educators; libraries; health professionals and medical institutions; government agencies; members of the herb, dietary supplement, cosmetic, and pharmaceutical industries; journalists; consumers; and others within over 70 countries. The organization occupies a historic 2.5-acre site in Austin, Texas where it publishes the quarterly journal HerbalGram, the monthly e-publication HerbalEGram, HerbClips (summaries of scientific and clinical publications), reference books, and other educational materials. ABC also hosts HerbMedPro, a powerful herbal database, covering scientific and clinical publications on more than 220 herbs. ABC also co-produces the “Herbal Insights” segment for Healing Quest, a television series on PBS. Previous product-specific monographs developed by ABC have focused on CVT-E002^® (the active ingredient in the ginseng-based formulation COLD-FX^®), POM^® Wonderful Pomegranate Juice, and the herbal combination product Sinupret^®.

ABC is tax-exempt under section 501(c) (3) of the IRS Code. Information: Contact ABC at P.O. Box 144345, Austin, TX 78714-4345, Phone: 512-926-4900. Website: http://www.herbalgram.org/.

About Horphag Research

Horphag Research Ltd., founded in 1925 and based in Geneva, Switzerland, is the exclusive worldwide supplier of Pycnogenol, extracted from French maritime pine bark (Pinus pinaster). The company leads the world in Pycnogenol research, and new applications for Pycnogenol are explored every year. Pycnogenol is available in more than 700 dietary supplements, multivitamins and health products worldwide. Pycnogenol is a registered trademark of Horphag Research Ltd and its applications are protected by US and international patents. Natural Health Science, in Hoboken, NJ, is the exclusive North American raw material supplier of Pycnogenol. More information about Pycnogenol is available at the company’s website: www.pycnogenol.com.

Vitamin D supplementation may improve HDL cholesterol levels

MedWire News: Low levels of serum 25(OH)D (vitamin D) are associated with low levels of high-density lipoprotein (HDL) cholesterol and reduced waist circumference, report researchers in the Journal of Clinical Lipidology.

Low levels of vitamin D have previously been associated with markers of cardiovascular disease (CVD) risk, explain Kevin Maki (Provident Clinical Research, Glen Ellyn, Illinois, USA) and team.

In this cross-sectional study, the investigators recruited 257 men and women to assess links between vitamin D level and selected CVD risk markers including components of the metabolic syndrome such as HDL cholesterol, triglycerides, and abdominal obesity.

They also evaluated dietary intake using food frequency and dietary supplement questionnaires.

Maki et al report that HDL cholesterol level significantly increased in a graded fashion, with levels increasing from 48.4 mg/dl to 62.3 mg/dl (1.25 to 1.61 mmol/l) among participants in the lowest and highest tertiles of serum vitamin D, respectively.

Each 10-ng/ml increment in serum vitamin D level was associated with an increase in HDL cholesterol of 3.80–4.20 mg/dl (0.10–0.11 mmol/l) following adjustment for established determinants of HDL cholesterol.

The authors point out that, if confirmed, this finding could have important implications with regard to coronary heart disease, as previous studies have shown that a 1.00 mg/dl (0.02 mmol/l) increase in HDL cholesterol is linked to a 4–6% decrease in risk for the condition.

Of note, each 1-ng/ml increment in vitamin D was associated with a significant 0.31 cm smaller waist circumference. But the researchers say this could be explained by the fact that vitamin D is fat soluble and there is therefore a “greater storage capacity for vitamin D in overweight and obese individuals, which may result in a reduced circulating concentration.”

Other factors such as triglycerides showed a graded inverse relationship with vitamin D level, and metabolic syndrome prevalence decreased significantly from the lowest to the highest tertile.

“These results suggest that clinical trials should be undertaken to assess the impact of increasing vitamin D intake on the metabolic cardiovascular risk factor profile,” concludes the team.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

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Source: www.lipidsonline.com

Alpha-lipoic acid improves vascular endothelial function in patients with type 2 diabetes: a placebo-controlled randomized trial.

Heinisch BB, Francesconi M, Mittermayer F, Schaller G, Gouya G, Wolzt M,
Pleiner J.

Medical University of Vienna, Vienna, Austria.

Eur J Clin Invest 2009 Abstract Objective The aim of this study was to investigate the effect of alpha-lipoic acid (ALA) treatment on endothelium-dependent and -independent vasodilatation, assessed by forearm blood flow (FBF), in patients with type 2 diabetes mellitus.  Research design and methods A total of 30 subjects with type 2 diabetes were included in this randomized, controlled, double-blinded, parallel group study. FBF responses to intra-arterial acetylcholine (ACh) and glycerol trinitrate (GTN) were measured before and after 21 days of intravenous treatment with 600 mg alpha-lipoic acid or placebo. Results FBF responses were comparable at baseline. After treatment, FBF reactivity to ACh and GTN was unchanged in subjects receiving placebo. By contrast, ALA treatment increased endothelium-dependent vasodilatation to ACh (P < 0.05) but not to GTN compared with baseline. Conclusions Intravenous ALA treatment improves endothelium-dependent vasodilatation in patients with type 2 diabetes, in the absence of effects on forearm vasomotor function. If this salutary action  translates into vascular risk reduction remains to be established.

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