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Chara Fiebig
This paper is an ongoing update of the sports nutrition review article originally published as the lead paper to launch the Journal of the International Society of Sports Nutrition in 2004 and updated in 2010. It presents a well-referenced overview of the current state of the science related to optimization of training and performance enhancement through exercise training and nutrition. Notably, due to the accelerated pace and size at which the literature base in this research area grows, the topics discussed will focus on muscle hypertrophy and performance enhancement. As such, this paper provides an overview of: 1.) How ergogenic aids and dietary supplements are defined in terms of governmental regulation and oversight; 2.) How dietary supplements are legally regulated in the United States; 3.) How to evaluate the scientific merit of nutritional supplements; 4.) General nutritional strategies to optimize performance and enhance recovery; and, 5.) An overview of our current understanding of nutritional approaches to augment skeletal muscle hypertrophy and the potential ergogenic value of various dietary and supplemental approaches.
This updated review is to provide ISSN members and individuals interested in sports nutrition with information that can be implemented in educational, research or practical settings and serve as a foundational basis for determining the efficacy and safety of many common sport nutrition products and their ingredients.
Evaluating the scientific merit of articles and advertisements about exercise and nutrition products is a key skill that all sports nutrition professionals must possess. To assist members and other advocates of the International Society of Sports Nutrition (ISSN) in keeping up to date about the latest findings in sports nutrition, the ISSN Exercise & Sports Nutrition Review: Research & Recommendations has been updated. The initial version of this paper was the first publication used to help launch the Journal of the International Society of Sports Nutrition (JISSN, originally called the Sports Nutrition Review Journal). This paper provides a definition of ergogenic aids and dietary supplements and discusses how dietary supplements are legally regulated. Other sections highlight how to evaluate the scientific merit of nutritional supplements and provide general nutritional strategies to optimize performance and enhance recovery. Finally, a brief overview of the efficacy surrounding many supplements commonly touted to promote skeletal muscle hypertrophy and improve physical performance is provided. Based upon the available scientific literature testing the efficacy and safety of the nutritional supplements discussed herein, all nutritional supplements discussed in this paper have been placed into three categories based upon the quality and quantity of scientific support available:
Since the last published version of this document in 2010 [1], the general approach to categorization has not changed, but several new supplements have been introduced to the market and are subsequently reviewed in this article. In this respect, many supplements have had additional studies published that has led to some supplements being placed into a different category or removed from the review altogether. We understand and expect that some individuals may not agree with our interpretations of the literature or what category we have assigned a particular supplement, but it is important to appreciate that some classifications may change over time as more research becomes available.
In the United States, dietary supplements are classified as food products, not drugs, and there is generally no mandate to register products with the FDA or obtain FDA approval before producing or selling supplements to consumers. However, if a dietary supplement manufacturer is making a claim about their product, the company must submit the claims to FDA within 30 days of marketing the product. Compare this, for example, with Canada where under the Natural Health Product (NHP) Regulations enacted in 2004 supplements must be reviewed, approved, and registered with Health Canada. The rationale for the U.S. model is based on a presumed long history of safe use; hence there is no need to require additional safety data.
An adverse event is any health-related event associated with the use of a dietary supplement that is adverse. A serious adverse event is an adverse event that (A) results in (i) death, (ii) a life-threatening experience, (iii) inpatient hospitalization, (iv) a persistent or significant disability or incapacity, or (v) a congenital anomaly or birth defect; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A). Once it is determined that a serious adverse event has occurred, the manufacturer, packer, or distributor (responsible person) of a dietary supplement whose name appears on the label of the supplement shall submit to the Secretary of Health and Human Services any report received of the serious adverse event accompanied by a copy of the label on or within the retail packaging of the dietary supplement. The responsible person has 15 business days to submit the report to FDA after being notified of the serious adverse event. Following the initial report, the responsible person must submit follow-up reports of new medical information that they receive for one-year.
When DSHEA was passed in 1994, it contained a provision requiring that the FDA establish and enforce current Good Manufacturing Practices (cGMPs) for dietary supplements. However, it was not until 2007 that the cGMPs were finally approved, and not until 2010 that the cGMPs applied across the industry, to large and small companies alike. The adherence to cGMPs has helped protect against contamination issues and should serve to improve consumer confidence in dietary supplements. The market improved as companies became compliant with cGMPs, as these regulations imposed more stringent requirements such as Vendor Certification, Document Control Procedures, and Identity Testing. These compliance criteria addressed the problems that had damaged the reputation of the industry with a focus on quality control, record keeping, and documentation.
According to the 1990 Nutrition Labeling and Education Act (NLEA), the FDA can review and approve health claims (claims describing the relationship between a food substance and a reduced risk of a disease or health-related condition) for dietary ingredients and foods. However, since the law was passed it has only approved a few claims. The delay in reviewing health claims of dietary supplement ingredients resulted in a lawsuit, Pearson v. Shalala, filed in 1995. After years of litigation, in 1999 the U.S. Court of Appeals for the District of Columbia Circuit ruled that qualified health claims may be made about dietary supplements with approval by FDA, as long as the statements are truthful and based on adequate science. Supplement or food companies wishing to make health claims or qualified health claims about supplements can submit research evidence to the FDA for review.
While some companies have falsely attributed research on different dietary ingredients or dietary supplements to their own products, suppressed negative research findings, and/or exaggerated results from research studies, the trend in the sports nutrition industry has been to develop scientifically sound supplements. This trend toward greater research support is the result of: (1) attempts to honestly and accurately inform the public about results; (2) efforts to obtain data to support safety and efficacy on products for the FDA and the FTC; and/or, (3) endeavors to provide scientific evidence to support advertising claims and increase sales. While the push for more research is due in part to greater scrutiny from the FDA and FTC, it is also in response to an increasingly competitive marketplace where established safety and efficacy attracts more consumer loyalty and helps ensure a longer lifespan for the product in commerce. Companies that adhere to these ethical standards tend to prosper while those that do not will typically struggle to comply with FDA and FTC guidelines resulting in a loss of consumer confidence and an early demise for the product.
A common question posed by athletes, parents, and professionals surrounding dietary supplements relates to how they are manufactured and perceived supplement quality. In several cases, established companies who develop dietary supplements have research teams who scour the medical and scientific literature looking for potentially effective nutrients. These research teams often attend scientific meetings and review the latest patents, research abstracts presented at scientific meetings, and research publications. Leading companies invest in basic research on nutrients before developing their supplement formulations and often consult with leading researchers to discuss ideas about dietary supplements and their potential for commercialization. Other companies wait until research has been presented in patents, research abstracts, or publications before developing nutritional formulations featuring the nutrient. Upon identification of new nutrients or potential formulations, the next step is to contact raw ingredient suppliers to see if the nutrient is available, if it is affordable, how much of it can be sourced and what is the available purity. Sometimes, companies develop and pursue patents involving new processing and purification processes because the nutrient has not yet been extracted in a pure form or is not available in large quantities. Reputable raw material manufacturers conduct extensive tests to examine purity of their raw ingredients. When working on a new ingredient, companies often conduct series of toxicity studies on the new nutrient once a purified source has been identified. The company would then compile a safety dossier and communicate it to the FDA as a New Dietary Ingredient submission, with the hopes of it being allowed for lawful sale.
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