Posts Tagged ‘Dietary supplements’

Safety of Zinc gluconate

Tuesday, December 2nd, 2008

In September 2003, zicam faced lawsuits from users who claimed that the product negatively affected their sense of smell, and sometimes taste. However, Zicam advocates assert that instructions on the container clearly indicate proper use, which will allow users to avoid these problems. In January 2006, 340 lawsuits were settled for $12 million.[9] In early 2004, at the height of the controversy, Matrixx Initiatives, Inc., the maker of Zicam, claimed that only a small number of people had experienced problems and that anosmia (loss of smell) can, amongst others, also be caused by the common cold itself. Matrixx also claimed that zinc gluconate dissolves into zinc ions and gluconate, and that both are naturally occurring compounds which are found in all human tissues. They also claim that Zicam is a buffered gel which is formulated to have a neutral pH. The plaintiffs countered Matrixx, claiming that many of the patients had experienced a strong and very painful burning sensation when they used the product, indicating damage to the nasal tissue. No part of the settlement targeted the product’s removal from sale, and the nasal gel continues to be available at drug stores throughout the USA. The two creators of Zicam have come under scrutiny. Robert Steven Davidson received his PhD from an unaccredited university which has since closed while Charles B. Hensley has been cited by the US Food and Drug Administration for selling unapproved drugs over the Internet.[10]

The U.S. Food and Drug Administration (FDA) considers zinc gluconate to be generally recognized as safe (GRAS) when used in accordance with good manufacturing practice, although this does not constitute a finding by the FDA that the substance is a useful dietary supplement.[11]

Zinc gluconate glycine of Zinc gluconate glycine

Tuesday, December 2nd, 2008

Zinc gluconate glycine is a formulation containing zinc gluconate and the amino acid glycine. It is available as an over-the-counter remedy for the common cold. Zinc gluconate, when made into a lozenge by itself, has a mildly acidic taste, which will turn into a bitter taste over a period of time. The addition of large amounts of glycine to the lozenge produces a much milder and more stable taste. The resulting commercial products have a nearly unlimited shelf life. This compound was patented in 1985 by John C. Godfrey of Godfrey Science & Design. The Quigley Corporation has trademarked the name ZIGG for the compound. The company is also the only major supplier of zinc gluconate glycine, distributed under the brand name Cold-Eeze. All clinical trials of the compound to date have involved the lozenges in this product family. Like zinc gluconate, zinc gluconate glycine has been shown in clinical trials to shorten the mean and median duration of symptoms of the common cold.[3] The amount of glycine added can range anywhere from two to twenty moles of glycine for each mole of zinc gluconate (US Patent 4,684,528, Claim 1). The manufacturer claims that its product reduces the duration of common cold symptoms by 42%, compared to the natural duration. However, this benefit depends on regular usage (every few hours of being awake) beginning with the first appearance of symptoms. Repeated clinical trials of the compound have generally shown a measurable, but varied, benefit relative to a placebo, typically on the order of a one- to four-day reduction in symptom duration.[4][5][6] A 2001 study seemed to show that zinc gluconate only works with certain types of colds, and its effect is most measurable after the 2nd or 3rd day.[7] One review of the research found that out of nine controlled experiments using zinc lozenges, the results were positive in four studies, and no better than placebo in five.[8] This review also suggested that the research is characterized by methodological problems, including differences in the dosage amount used, and the use of self-report data.

What is Zinc gluconate

Tuesday, December 2nd, 2008

Zinc gluconate is the zinc salt of gluconic acid. It is an ionic compound consisting of two moles of gluconate for each mole of zinc. Zinc gluconate is a popular form for the delivery of zinc as a dietary supplement.

Gluconic acid is found naturally, and is industrially manufactured by the fermentation of glucose, typically by Aspergillus niger, but also by other fungi, e.g. Penicillium, or by bacteria, e.g. Acetobacter, Pseudomonas and Gluconobacter.[1] In its pure form, it is a white to off-white powder. It can also be manufactured by electrolytic oxidation[2], although this is a more expensive process. The advantages are a lower microbiological profile, and a more complete reaction, yielding a product with a longer shelf life.

Zinc gluconate may interfere with the absorption of antibiotics, so combinations may be unsafe.

Scient ific studies ofZMA (supplement)

Tuesday, December 2nd, 2008

A 1999 study was undertaken on NCAA Football players during an 8 week spring training program. The control group was told to cease taking any nutritional supplements. Those who took the ZMA tablets showed greater increases in muscle strength, free testosterone levels, and IGF-1 levels.[3] This study was funded by SNAC Systems Inc. (the patent holders) and one of the study’s authors (Victor Conte) has equity in this company.

Another study in 2004 conducted jointly by the Exercise & Sport Nutrition Lab of Baylor University, IMAGINutrition, and the Journal of the International Society of Sports Nutrition, found that ZMA has no effect on strength, hormone levels, or anaerobic capacity.[4]

What is ZMA (supplement)

Tuesday, December 2nd, 2008

ZMA (Zinc monomethionine aspartate and Magnesium Aspartate) is a supplement used by bodybuilders and athletes. It was developed by Victor Conte (founder of BALCO Laboratories in Burlingame, California) and is a combination of zinc, magnesium and vitamin B6. The formula is “patent pending” and the name “ZMA” trademarked by SNAC System Inc, also founded by Victor Conte. ZMA is claimed to raise testosterone and IGF-1 levels which may aid in gaining muscle size and strength.

ZMA is a combination of two minerals, zinc and magnesium, and Vitamin B-6 or pyridoxine. All three of these compounds are important in biological processes, and while studies have shown that most Americans get enough zinc and Vitamin B6,[1] more than 50% are deficient in magnesium.[2]

An increase in exercise can lead to the loss of vitamins and minerals making it particularly important for bodybuilding due to the blood sugar level rises and urination increases, increasing the loss of magnesium, zinc, B12, B6, folic acid, and many other nutrients. Although drinking water re-hydrates an athlete, fruit juice, sports drinks or foods high in water such as vegetables are needed to replenish water-soluble nutrients.

The proportion of ingredients generally used in products is 20-30 mg Zinc, 400-500 mg Magnesium and ~10mg B6. According to the label directions, ZMA should be taken before bed on an empty stomach (2 hours after eating your last meal and at least 30 minutes prior to any other supplements). The product should not be taken with calcium (cheese,milk,etc.), the reason being that calcium blocks the absorption of zinc.

Marketing claims under scrutiny in Canada and the United States

Tuesday, December 2nd, 2008

In January 2007, marketing statements for a goji juice product were subject of an investigative report by CBC Television’s consumer advocacy program Marketplace (TV series)[33].

By one specific example in the CBC interview, Earl Mindell claimed the Memorial Sloan-Kettering Cancer Center in New York had completed clinical studies showing that use of wolfberry juice would prevent 75% of human breast cancer cases, a statement false in three ways:
no such project has been undertaken at Memorial Sloan-Kettering[34]
according to the National Cancer Institute of the US National Institutes of Health, no natural or pharmaceutical agent has been shown in clinical trials to fully prevent breast cancer, only to reduce its risk [35]; specifically, there are no completed or ongoing clinical trials in the United States testing the effects of wolfberries or juice on breast cancer outcomes [36] or any other disease[37] and
beyond preliminary laboratory studies[52][53][54] and one Chinese clinical trial described only in an abstract[55], there is no scientific evidence for wolfberry phytochemicals or wolfberry juice having cancer-preventive properties.

Significant in nutrient and phytochemical composition, wolfberries are being developed[38][39][40] as new products in the functional food industry under FDA regulatory review since December, 2006 for label and marketing claims[41] as being conducted in 2007 by the European Union (above).

During 2006, the FDA placed two goji juice distributors on notice with warning letters about marketing claims. These statements were in violation of the United States Food, Drug and Cosmetic Act [21 USC/321 (g)(1)][42] because they “establish the product as a drug intended for use in the cure, mitigation, treatment, or prevention of disease” when wolfberries or juice have had no such scientific evaluation. Additionally stated by the FDA, the goji juice was “not generally recognized as safe and effective for the referenced conditions” and therefore must be treated as a “new drug” under Section 21(p) of the Act. New drugs may not be legally marketed in the United States without prior approval of the FDA, as stated in the letters below:
Dynamic Health Laboratories Inc. of Brooklyn, New York, May 8, 2006[43]
Healthsuperstore.com of Elk Grove, California, August 7, 2006[44]

Marketing claims under scrutiny in Europe of Wolfberry

Tuesday, December 2nd, 2008

In February 2007, the Food Standards Agency (FSA) of Great Britain, an advisor for food safety to the European Food Safety Authority of the European Union (EU), published an inquiry to retailers and health food stores requesting evidence of significant use of wolfberries in Europe before 1997.[47] This period would document a safety history and evaluate how “novel” the berries are in the EU, affecting their authorization status for sale.

Proponents hoped this review would provide important safeguards for consumers by checking whether new foods are suitable for the whole population, including people with food allergies. Opponents on the other hand feared it would limit consumer choice and protect monopolistic interests rather than the public.[48] Food safety in the EU relies importantly on a scientific basis for label information on foods like wolfberries that may be claimed to furnish health benefits.[49]

In June 2007, the FSA announced its decision that wolfberries indeed had a history of use in Great Britain before 1997.[50][51] Accordingly, wolfberries do not require registration as a novel food.

Commercial products marketed outside Asia

Tuesday, December 2nd, 2008

Typical of many exotic fruits being introduced into western food and beverage commerce, wolfberry is best known as a juice marketed over the Internet since 2002, often via multi-level marketing that emphasizes its health benefits, and with an increasing presence in health food stores and grocery markets in many countries. While juice prepared entirely from fresh wolfberries is rare, blends containing several other berry and fruit juices are used for nearly all “wolfberry” juice products, many of which are nevertheless labeled as “goji juice”. The percentage of wolfberry contained in these juices is generally not stated on such products’ labels.

Since 2005, wolfberry has been increasingly mentioned in reports on the emerging functional food industry as one of the “exotic superfruits”. Superfruit is meant to imply nutrient richness with medical research results indicating potential health benefits, combined with uncommon but appealing taste, pigmentation, and antioxidant strength.[45] An executive of one network marketing company was quoted as saying the juice market alone for wolfberries would be valued at more than $1 billion by 2013.[46]

Other wolfberry consumer applications are as dried berries (picture above), berry pieces in granola bars, and skin soap made from seed oils.

Commercial suppliers have processed wolfberry as an additive for manufacturing, such as juice concentrate, whole fruit purée, powders from juice or juice concentrate made from spray drying, pulp powders, whole or ground seeds, seed oils (as done for grape seed oil), and essential oils derived from seeds.

Marketing of Wolfberry

Tuesday, December 2nd, 2008

Since the early 21st century, the dried fruit has been marketed in the West as a health food (typically under the name “Tibetan goji berry”), often accompanied by scientifically-unsupported claims regarding its purported health benefits.

By unconfirmed reports, its most recognized nutritional attribute is an exceptional level of vitamin C, reputed to be among the highest in natural plants.[citation needed] However, demonstrated by independent assays on dried berries to actually be in a range of 29-148 mg per 100 grams of fruit,[41] the level is actually comparable to many citrus fruits and strawberries[30][31]. Although considered nutritionally “excellent”, wolfberry’s vitamin C content is considerably lower than for numerous other fruits and berries, such as the Australian Kakadu “billy goat” plum (Terminalia ferdinandiana), blackcurrant, and sea-buckthorn.[32]

Companies marketing the berries often also include the unsupported claim that a Chinese man named Li Qing Yuen, who was said to have consumed wolfberries daily, lived to the age of 252 years (1678-1930), another one of the numerous myths surrounding the health benefits of wolfberry.

Functional food and beverage applications

Tuesday, December 2nd, 2008

Cultivated for a variety of food and beverage applications within China, but increasingly today for export as dried berries, juice and powders of pulp or juice, wolfberries are prized for their versatility of color and nut-like taste in common meals, snacks, beverages and medicinal applications. A major effort is underway in Ningxia, China to process wolfberries for “functional” wine.