Special Dietary Use Research Articles

Development of a Functional Beverage Formulation with High Protein Content, Inulin and Stevia

A beverage formulation with proteins of high quality, inulin, Stevia and C vitamin has been prepared. The protein source was bovine plasma which was concentrated and demineralized by a combined membrane methodologies as microfiltration, ultrafiltration and discontinues diafiltration. The use of inulin as protective agent to prevent protein concentrate denaturation during freeze-drying was assayed. The inulin is a versatile food ingredient and it also has health benefits. The powder obtained has improved sensory characteristic and high solubility. Stevia has been added as sweetness, being a low-carbohydrate, low-sugar food alternative. The formulation could be destined as protein supplement with functional properties or for special dietary use.

The definition of dietary fiber – discussions at the Ninth Vahouny Fiber Symposium: building scientific agreement

A definition for dietary fiber was adopted in June 2009 by the Codex Alimentarius Commission based on the recommendation for endorsement of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) in November 2008. The definition listed three categories of carbohydrate polymers that are not hydrolyzed by the endogenous enzymes in the small intestine of humans. However, the definition left the inclusion of carbohydrates with degrees of polymerization (DP) in the range of 3 and 9 to the discretion of national authorities and left the ‘physiological effect(s) of benefit to health’ as undefined. The ILSI Europe and ILSI North America's committees on dietary carbohydrates organized a forum at the Ninth Vahouny Fiber Symposium in 2010 to discuss these implementation issues with the objective of building scientific consensus on how to resolve them. The results of this session are encouraging and indicated that the scientific community agrees on maintaining a worldwide consensus regarding the inclusion of non-digestible carbohydrates with ≥DP3 as dietary fiber and on a core, non-exhaustive list of beneficial physiological effects that dietary fibers have. These results are consistent with previous worldwide agreements.

Development and evaluation of an integrated method for the measurement of total dietary fibre

An integrated total dietary fibre (TDF) method, consistent with the recently accepted CODEX definition of dietary fibre, has been developed. The CODEX Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) has been deliberating for the past 8 years on a definition for dietary fibre that correctly reflects the current consensus thinking on what should be included in this definition. As this definition was evolving, it became evident to us that neither of the currently available methods for TDF (AOAC Official Methods 985.29 and 991.43), nor a combination of these and other methods, could meet these requirements. Consequently, we developed an integrated TDF procedure, based on the principals of AOAC Official Methods 2002.02, 991.43 and 2001.03, that is compliant with the new CODEX definition. This procedure quantitates high- and low-molecular weight dietary fibres as defined, giving an accurate estimate of resistant starch and non-digestible oligosaccharides also referred to as low-molecular weight soluble dietary fibre. In this paper, the method is discussed, modifications to the method to improve simplicity and reproducibility are described, and the results of the first rounds of interlaboratory evaluation are reported.

Codex final definition of dietary fibre: issues of implementation

Introduction At its 30th session in South Africa in November 2008, the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) agreed on a definition of dietary fibre. Although many aspects of what can be called “dietary fibre” were resolved, the application of this definition raises additional issues in need of resolution. Objectives The goal of this paper is to discuss the major areas at issue in implementing the new Codex definition of dietary fibre: (1) the footnote that individual countries can decide whether they accept oligosaccharides with a degree of polymerization (DP) from 3 to 9 (included) as being fibre; and 2) guidance on which physiological effects are beneficial. Less critical but still important is the issue of animal sources of fibre not requiring proof of a beneficial physiological effect; and the effect of processing on fibre. Results and conclusion Unless all countries accept (or do not accept) that carbohydrate polymers with 3–9 monomeric units are dietary fibre, there will be two, rather than one definition. Again, if each country has its own criteria as to the physiological benefits of fibre and how to verify those benefits there will be as many “definitions” of fibre as there are effects accepted by all the member states. Given the importance to consumers, food companies, researchers, and regulatory agencies in having one definition, it is incumbent on all of us in the field to work toward that end.

Functional foods in Europe: international developments in science and health claims

Background Within the framework of Codex Alimentarius, attempts are being made at international level to establish guidelines for use of nutrition and health claims. An important issue that has to be addressed is the process of scientific substantiating of claims on foods. Objective To provide an insight into the current step procedure of the proposed draft recommendations on the scientific basis of health claims. These Codex recommendations are intended to facilitate governments’ own evaluation of health claims made by the industry. Methods Review of comments of governments, observers and non-governmental organizations (NGOs) and relevant references to the proposed draft recommendations of the last sessions of the Codex Committee on Nutrition and Food for Special Dietary Uses (CCNFSDU). A literature search was performed using the PubMed database. Results/Conclusions Several proposed draft recommendations on the scientific substantiation of health claims have been considered and amended by the CCNFSDU in recent years but the work is not yet complete. The current work draws on the work of FUFOSE and PASSCLAIM and also on that of WHO and FDA. Given the important role of Codex in food safety, the draft recommendations emphasize circumstances where additional evaluation of safety or nutritional safety needs to be considered. High quality human intervention studies are the prime evidence needed to substantiate claims but there is recognition that, in some cases, only observational studies may be available. Animal and in vitro studies will also be evaluated as part of the totality of the evidence. It has been suggested that the recommendations should include re-evaluation of claims after a certain time period, or if new evidence calls into question the scientific validity underpinning the claims. Setting out a common approach for the substantiation of health claims is an important step in the use of health claims around the world. There is a need to reflect emerging as well as consensus science. The substantiating evidence should be proportionate to the claim. Further progress in the elaboration of this relevant Codex text is needed to reach consensus.

Codex recommendations on the scientific basis of health claims

Within the framework of Codex Alimentarius, attempts are being made at international level to establish guidelines for use of nutrition and health claims. An important issue that has to be addressed is the process of scientific substantiating of claims on foods. To provide an insight into the current step procedure of the proposed draft recommendations on the scientific basis of health claims. These Codex recommendations are intended to facilitate governments' own evaluation of health claims made by the industry. Review of comments of governments, observers and non-governmental organizations (NGOs) and relevant references to the proposed draft recommendations of the last sessions of the Codex Committee on Nutrition and Food for Special Dietary Uses (CCNFSDU). A literature search was performed using the PubMed database. Several proposed draft recommendations on the scientific substantiation of health claims have been considered and amended by the CCNFSDU in recent years but the work is not yet complete. The current work draws on the work of FUFOSE and PASSCLAIM and also on that of WHO and FDA. Given the important role of Codex in food safety, the draft recommendations emphasize circumstances where additional evaluation of safety or nutritional safety needs to be considered. High quality human intervention studies are the prime evidence needed to substantiate claims but there is recognition that, in some cases, only observational studies may be available. Animal and in vitro studies will also be evaluated as part of the totality of the evidence. It has been suggested that the recommendations should include re-evaluation of claims after a certain time period, or if new evidence calls into question the scientific validity underpinning the claims. Setting out a common approach for the substantiation of health claims is an important step in the use of health claims around the world. There is a need to reflect emerging as well as consensus science. The substantiating evidence should be proportionate to the claim. Further progress in the elaboration of this relevant Codex text is needed to reach consensus.

Establishing new principles for nutrient reference values (NRVs) for food labeling purposes

Many countries such as The Republic of Korea have established their own nutritional standards, collectively termed Nutrient Reference Values(NRVs), and they vary due to the science which was reviewed, the purposes for which they are developed, and issues related to nutrition and food policy in the country. The current effort by the Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses (CNFSDU) to update the NRVs that were established following the Helsinki Consultation in 1988 represents an opportunity to develop a set of reference values reflecting current scientific information to be used or adapted by many countries. This paper will focus on possible approaches to selecting or developing reference values which would serve the intended purpose for nutrition labeling to the greatest extent possible. Within the United States, the Food and Drug Administration (U.S. FDA) is currently reviewing regulations on nutrition labeling to better address current health issues, and is expected to enter into a process in the next few months to begin to explore how best to update nutrient Daily Values (DVs), most of which are still based on the Recommended Dietary Allowances (RDAs) of the Food and Nutrition Board, U.S. National Academy of Sciences, last reviewed and revised in 1968. In this presentation, I review the current purposes in the U.S. for nutrition labeling as identified in the 1938 Food, Drug, and Cosmetic Act as amended, the scientific basis for current nutrition labeling regulations in the United States, and the recommendations made by the recent Committee on Use of Dietary Reference Intakes in Nutrition Labeling of the Institute of Medicine (2003) regarding how to use the DRIs in developing new DVs to be used on the label in the United States and Canada. Based on these reviews, I then provide examples of the issues that arise in comparing one approach to another. Much of the discussion focuses on the appropriate role of nutrient labeling within the Nutrition Facts panel, one of the three major public nutrition education tools in the United States (along with MyPyramid and Dietary Guidelines for Americans).

AAP Publications Retired and Reaffirmed

Technical Report: Alternative Dispute Resolution in Medical Malpractice. Pediatrics. 2001;107:602–607Policy Statement: Professional Liability Coverage for Residents and Fellows. Pediatrics. 2000;106:605–609Policy Statement: Immunizations for Native American Children. Pediatrics. 1999;104:564–567Circumcision Policy Statement. Pediatrics. 1999;103:686–693Policy Statement: Retinoid Therapy for Severe Dermatological Disorders. Pediatrics. 1992;90:119–120Policy Statement: Smallpox Vaccine. Pediatrics. 2002;110:841–845Policy Statement: Cholesterol in Childhood. Pediatrics. 1998;101:141–147Policy Statement: Privacy Protection of Health Information: Patient Rights and Pediatrician Responsibilities. Pediatrics. 1999;104:973–977Policy Statement: Guiding Principles, Attributes, and Process to Review Medical Management Guidelines. Pediatrics. 2001;108:1378–1382Policy Statement: Death of a Child in the Emergency Department: Joint Statement by the American Academy of Pediatrics and the American College of Emergency Physicians. Pediatrics. 2002;110:839–840Policy Statement: Reimbursement for Foods for Special Dietary Uses. Pediatrics. 2003;111:1117–1119Policy Statement: Age Limits of Pediatrics. Pediatrics. 1998;81:736Policy Statement: Postnatal Corticosteroids to Treat or Prevent Chronic Lung Disease in Preterm Infants. Pediatrics. 2002;109:330–338Policy Statement: Auditory Integration Training and Facilitated Communication for Autism. Pediatrics. 1998;102:431–433Policy Statement: Counseling the Adolescent About Pregnancy Options. Pediatrics. 1998;101:938–940Clinical Report: Helping Children and Families Deal With Divorce and Separation. Pediatrics. 2002;110:1019–1023Policy Statement: Intensive Training and Sports Specialization. Pediatrics. 2000;106:154–157Policy Statement: Risk of Injury From Baseball and Softball in Children. Pediatrics. 2001;107:782–784Policy Statement: In-line Skating Injuries in Children and Adolescents. Pediatrics. 1998;101:720–722Policy Statement: The Treatment of Neurologically Impaired Children Using Patterning. Pediatrics. 1999;104:1149–1151Policy Statement: The Pediatrician's Role in Development and Implementation of an Individual Education Plan (IEP) and/or an Individual Family Service Plan (IFSP). Pediatrics. 1999;104:124–127Policy Statement: Guidelines for Home Care of Infants, Children, and Adolescents With Chronic Disease. Pediatrics. 1995;96:161–164Policy Statement: Health Supervision for Children With Sickle Cell Disease. Pediatrics. 2002;109:526–535The Prevention of Unintentional Injury Among American Indian and Alaska Native Children: A Subject Review. Pediatrics. 1999;104:1397–1399Policy Statement: Safe Transportation of Newborns at Hospital Discharge. Pediatrics. 1999;104:986–987Policy Statement: Surveillance of Pediatric HIV Infection. Pediatrics. 1998;101:315–319Policy Statement: Transporting Children With Special Health Care Needs. Pediatrics. 1999;104:988–992Policy Statement: Trampolines at Home, School, and Recreational Centers. Pediatrics. 1999;103:1053–1056Policy Statement: Scope of Practice Issues in the Delivery of Pediatric Health Care. Pediatrics. 2003;111:426–435.

Global Standard for the Composition of Infant Formula: Recommendations of an ESPGHAN Coordinated International Expert Group

The Codex Alimentarius Commission of the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) develops food standards, guidelines and related texts for protecting consumer health and ensuring fair trade practices globally. The major part of the world's population lives in more than 160 countries that are members of the Codex Alimentarius. The Codex Standard on Infant Formula was adopted in 1981 based on scientific knowledge available in the 1970s and is currently being revised. As part of this process, the Codex Committee on Nutrition and Foods for Special Dietary Uses asked the ESPGHAN Committee on Nutrition to initiate a consultation process with the international scientific community to provide a proposal on nutrient levels in infant formulae, based on scientific analysis and taking into account existing scientific reports on the subject. ESPGHAN accepted the request and, in collaboration with its sister societies in the Federation of International Societies on Pediatric Gastroenterology, Hepatology and Nutrition, invited highly qualified experts in the area of infant nutrition to form an International Expert Group (IEG) to review the issues raised. The group arrived at recommendations on the compositional requirements for a global infant formula standard which are reported here.

Food and Supplement Safety

Originally, foods that have the property to modulate body functions that contribute to preventing a disease were called functional foods. However, the term is now widely understood to mean foods that claim such biological effects beyond ordinary nutritional effects, based on scientific validation. Today, we eat food materials of compromised nutritive value because of milling and processing. Furthermore, there is not enough time for a healthy balanced meal. Dietary supplements and functional foods are a prudent choice to offset these limitations in our daily lives. The term “physiologically functional foods” or simply “functional foods” was conceived in the context of nutrition during space travel. The modern concept of functional food for the general population was proposed by the Japanese academic society in the early 1980s and legislation on functional foods was first implemented as Foods for Specified Health Use (FOSHU). Decisions and policies from global regulatory bodies have become increasingly influential for dietary supplement companies. Such bodies include Codex Alimentarius, the World Health Organization, and the Food and Agriculture Organization. The International Alliance of Dietary Food Supplement Associations works together with these international organizations to ensure that the views of the dietary supplement industry are considered in developing policy. The Dietary Supplement Health and Education Act of 1994 was directed at ensuring that a dietary supplement is safe before it is marketed in the United States. In 1991, the Japanese Ministry of Health and Welfare established the FOSHU labeling regulation. It was implemented by adding a new category of FOSHU to Foods for Special Dietary Uses in the Nutrition Improvement Law. Momentum in Japan seems to be in the right direction, providing the rest of the world with an opportune platform for further development.

腎疾患患者用の低蛋白質・高エネルギー食パンの主観的ならびに客観的評価

Dietary therapy is extremely important for renal failure patients, and the diet for these patients should be based on low-protein and high-energy foods. Low-protein and high-energy rice and noodles as staple foods have already been developed and utilized for dietary therapy, although low-protein and high-energy bread is not presently available. We made low-protein and high-energy loaf samples exclusively for kidney disease patients by using starch flour that is designated as a food for special dietary use. We compared this exclusive bread to ordinary bread made of hard flour, and performed organoleptic tests (n=56), textural measurements and color recognition tests.The exclusive loaf samples made from starch flour gave high-preference scores in the organoleptic tests. In comparison to wheat bread, the nutritive values of the sample loaves were lower in protein (-32%, -45%) higher in energy (+37%, +40%), lower in phosphorus (-16%, -20%), lower in potassium (-16%, -20%) and lower in sodium (-67%, -66%). We conclude from these results that this exclusive bread made from starch flour is potentially useful as a staple food in dietary therapy for renal failure patients who require special foods.

Nutrition labelling and claims: Concerns and challenges; experiences from the Asia Pacific Region

Nutrition labelling and claims: Concerns and challenges; experiences from the Asia Pacific Region

The Nutritional Evaluation of Underutilized Cereals and Buckwheat

We evaluated the nutritional factors of underutilized cereals (spelt, emmer, einkorn, millet, foxtail millet, semiperennial rye, naked oat, and naked barley) and buckwheat. The basic food components as well as minor nutrients were determined. The analyses included dry matter, ash, protein, dietary fiber, fat, fatty acids, amino acids, minerals, and lipophilic and hydrophilic vitamins. Rutin was also determined in buckwheat. We hope to offer new recipes for the healthy food production and for special dietary use (diabetes, celiac disease, phenylketonuria diet, etc.). Use of the germinated seeds is also suggested. The examples of some healthy food products in the Czech Republic are mentioned.

Functional Foods and Health Claims Legislation: Applications to Dairy Foods

Abstract The purpose of this paper is to consider the regulatory status of functional foods and claims that can be made regarding their health-promoting properties, with emphasis on the situation in the US. Specific examples highlight probiotics, prebiotics, and cultures-added dairy foods. In the US, there is no legal definition of a functional food. The US Food and Drug Administration regulates four categories of foods: conventional foods, foods for special dietary use, medical foods, and dietary supplements. Three types of health-related messages can appear under certain conditions on food labels. Nutrient content claims and approved health claims can appear on all qualifying foods, while structure/function claims are allowed on dietary supplements. (Medical foods are exempt from all nutrition labeling regulations.) Currently, there are no allowed health claims for probiotics, prebiotics, or cultures-added dairy foods in the US. Several approaches for taking advantage of ‘functional’ dairy foods in the US are outlined.

Nutraceuticals, Functional Foods and Medical Foods

Abstract Breakthroughs in technologies are leading the way in the development and recognition of value-added commodities and processed foods, genetically engineered foods, ingredients of significant health value, medical foods, foods for special dietary use, dietary supplements, phytochemicals, herbal products and nutraceuticals, and their linkage to health and disease. This timely realization connects in part with the fact that one in three Americans are using some form of alternative and complementary/adjunct therapy. This trend has brought a tremendous increase in the number of products with perceived or anecdotal evidence of potential health and medical benefits and has led to major concerns about consumer safety and fraudulent claims. Nevertheless, the dramatic shift in consumer readiness, combined with increasing eagerness to save health care costs, has become an important issue for policy makers, regulatory bodies, scientific and medical communities, and companies, to make sure that appropriate mea...

The public health significance of dietary fructose

It is increasingly appreciated that some foods and food components, including fructose, have specific health benefits and/or potential risks. This recognition is associated with varied health claims and cautionary statements that can drive dynamic changes in food manufacture, selection, consumption, and views about food safety. It is imperative that the scientific and public health communities develop clear standards for evaluating potential benefits and risks, a process for accurately conveying sound public health information to consumers, and a mechanism for monitoring future changes in the food supply and relating these changes to potential health effects. In this paper we discuss specific and general considerations about the health effects of dietary fructose and provide a perspective on their public health significance. On the basis of currently available information, there is little basis for recommending increased or decreased use of fructose in the general food supply or in products for special dietary use.

Current regulatory status of foods for special dietary uses.

The Food and Drug Administration has redefined foods for "special dietary use". Such foods must now: (1) Supply a special dietary need that exists by reason of a physical or physiological condition, such as convalescence, a pregnancy, lactation, or by reason of a specific disease or disorder; (2) Supply a vitamin, mineral, or other dietary property to supplement diet by increasing total dietary intake; (3) Meet a special nutritional need as the sole item of the diet. The stricter definition of this category of food means that the conventional foods with added nutrients or food for which nutritional claims are made or nutritional information provided will no longer be considered as foods for special dietary uses, although they must conform to standard nutritional labeling requirements. The new regulation establishes a clearly delineated position within which the consumer, industry, and FDA can deal with special dietary foods without the past confusion as to what belonged in this category.