epiglucan and Coronary-Disease

Coronary heart disease (CHD) is the leading cause of death globally. Consumption of whole grains and cereal fiber, as part of a healthy diet, can lower the risk of CHD. Health claims on food products are effective in helping consumers select healthful diets. The US Food and Drug Administration was the first to approve a health claim, in 1997, between beta-glucan soluble fiber from whole oats, oat bran, and whole oat flour and reduced risk of CHD. Only a few countries have approved similar claims. Since 1997, a significant amount of additional evidence has been published on the relationship between oat beta-glucan and CHD. To assist other jurisdictions in potentially utilizing this claim, the full extent of data that supports this claim (ie, the evidence utilized by the US Food and Drug Administration to substantiate the claim, as well as the results of 49 clinical trials published since 1997) are reviewed here. The complexities involved in authoring evidence-based health claims, including the impact of processing on beta-glucan cholesterol-lowering efficacy in approving eligible beta-glucan products, are also discussed.

Topics: Anticholesteremic Agents; Avena; beta-Glucans; Cholesterol; Coronary Disease; Dietary Fiber; Edible Grain; Female; Humans; Male; United States; United States Food and Drug Administration

In 2010, Health Canada approved a heath claim acknowledging the link between increased oats (Avena sativa)-soluble fibre consumption and a reduction in total serum cholesterol levels. The approval also recognized the relationship between decreased total blood cholesterol concentration and a reduced risk of coronary heart disease. The functional food ingredient believed to be responsible for the hypocholesterolemic property of oats is β-glucan, a highly viscous, soluble fibre composed of d-glucose monomers linked by a combination of β-(1→4) and β-(1→3) glycosidic bonds. Found mainly in the endosperm cell wall of oats, β-glucan is thought to reduce total serum and low-density lipoprotein cholesterol by forming a viscous mass in the small intestine thus limiting intestinal absorption of dietary cholesterol as well as the re-absorption of bile acids. Given the evolution of research information with time as a result of the continual, rapid generation of new research data by laboratories around the world, it became imperative to examine the compatibility of the conclusion reached by Health Canada on the basis of the body of evidence contained in the initial petition submitted in January 2007, with newer post-2006 data. After careful evaluation, this work concludes on the basis of new research information that a dose of 3 g/day oat β-glucan consumed as part of a diet "free of saturated fatty acids" or "low in saturated fatty acids" could help to promote cardiovascular health.

Topics: Avena; beta-Glucans; Canada; Cardiovascular System; Cholesterol, HDL; Coronary Disease; Dietary Fiber; Health Promotion; Randomized Controlled Trials as Topic; Recommended Dietary Allowances; Risk Factors; Triglycerides

Government-approved health claims support dietary intervention as a safe and practical approach to improving consumer health and provide industry with regulatory guidelines for food product labels. Claims already allowed in the United States, United Kingdom, Sweden, and The Netherlands for reducing cholesterol through consumption of oat or barley soluble fiber provide a basis for review, but each country may have different criteria for assessing clinical evidence for a physiological effect. For example, the FDA-approved barley health claim was based on a petition that included 39 animal model studies and 11 human clinical trials. Since then, more studies have been published, but with few exceptions, clinical data continue to demonstrate that the consumption of barley products is effective for lowering total and LDL cholesterol. More research is needed to fully understand the mechanism of cholesterol reduction and the role of beta-glucan molecular weight, viscosity, and solubility. In an assessment of the physiological efficacy of a dietary intervention, consideration should also be given to the potential impact of physical and thermal food-processing treatments and genotypic variation in the barley source. New barley cultivars have been generated specifically for food use, possessing increased beta-glucan, desirable starch composition profiles, and improved milling/processing traits. These advances in barley production, coupled with the establishment of a government-regulated health claim for barley beta-glucan, will stimulate new processing opportunities for barley foods and provide consumers with reliable, healthy food choices.

Topics: beta-Glucans; Clinical Trials as Topic; Coronary Disease; Dietary Fiber; Food Labeling; Food, Organic; Hordeum; Humans; Netherlands; Sweden; United Kingdom; United States

Oat β-glucan reduces cholesterol levels and thus reduces the risk for coronary heart disease (CHD). However, its economic impact has not been well studied. We examined the economic impact of daily intake of ≥3 g of oat β-glucan in primary prevention of CHD in patients receiving statins or no pharmacologic treatment.. A decision model was developed to compare costs and outcomes associated with lowering cholesterol levels with no pharmacologic treatment and normal diet, no pharmacologic treatment plus ≥3 g/d of oat β-glucan, and statin therapy plus ≥3 g/d of oat β-glucan. The population comprised men 45, 55, or 65 years of age with no history of cardiovascular disease and a 10-year risk for CHD of 5%, 7.5%, or 10%. Clinical efficacy data were gathered from meta-analyses; safety data, costs, and utilities were gathered from published literature. Cost per quality-adjusted life years and number of first events were reported.. Maintaining ≥3 g/d of β-glucan may be cost-effective in men aged 45, 55, and 65 years with 10-year CHD risks of 5.0%, 7.5%, and 10.0% taking no pharmacologic treatment or on statins. It may also reduce first events of myocardial infarction and CHD death. Results are sensitive to oat β-glucan cost but insensitive to changes in other parameters. Maintaining ≥3 g of oat β-glucan daily remains cost-effective within plausible range of values.. β-glucan may be cost-effective for preventing CHD events in middle-aged men with no history of cardiovascular events whose 10-year CHD risk is ≥5%. Maintaining daily β-glucan intake may have considerable impact on first events.

Topics: Aged; beta-Glucans; Coronary Disease; Cost-Benefit Analysis; Humans; Male; Middle Aged; Primary Prevention; Quality-Adjusted Life Years

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule (IFR) that amended the regulation authorizing a health claim on soluble fiber from certain foods and risk of coronary heart disease (CHD), to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. FDA is taking this action to complete the rulemaking initiated with the IFR.

Topics: beta-Glucans; Coronary Disease; Dietary Fiber; Food Labeling; Hordeum; Humans; Marketing of Health Services; Risk Factors; United States; United States Food and Drug Administration

The Food and Drug Administration (FDA) is amending the health claim regulation entitled "Soluble fiber from certain foods and risk of coronary heart disease (CHD)" to add barley betafiber as an additional eligible source of beta-glucan soluble fiber. Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley flour. FDA is taking this action in response to a health claim petition submitted by Cargill, Inc. FDA previously concluded that there was significant scientific agreement that a claim characterizing the relationship between beta-glucan soluble fiber of certain whole oat and whole grain barley products and CHD risk is supported by the totality of publicly available scientific evidence. Based on the totality of publicly available scientific evidence, FDA now has concluded that in addition to certain whole oat and whole grain barley products, barley betafiber is also an appropriate source of beta-glucan soluble fiber. Therefore, FDA is amending the health claim regulation entitled "Soluble fiber from certain foods and risk of CHD" to include barley betafiber as another eligible source of beta-glucan soluble fiber.

Topics: beta-Glucans; Coronary Disease; Dietary Fiber; Food Labeling; Hordeum; Humans; United States; United States Food and Drug Administration

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on the relationship between beta-glucan soluble fiber from whole oat sources and reduced risk of coronary heart disease (CHD) by adding barley as an additional source of beta-glucan soluble fiber eligible for the health claim. FDA is taking this action to complete the rulemaking initiated with the interim final rule.

Topics: beta-Glucans; Coronary Disease; Dietary Fiber; Food Labeling; Hordeum; Humans; Hypercholesterolemia; United States; United States Food and Drug Administration