New research from Trinity College Dublin published in this month’s Annals of Surgery points to a potentially significant advance in the treatment of patients undergoing major cancer surgery. The esophageal research group at Trinity College Dublin and St. James’s Hospital carried out the study. A randomized controlled trial showed that omega-3 fatty acids given as part of an oral nutritional supplement resulted in the preservation of muscle mass in patients undergoing surgery for esophageal cancer, a procedure normally associated with significant weight loss and quality of life issues.

John V. Reynolds, professor of surgery at Trinity College Dublin and St. James’s Hospital, Dublin, and Aoife Ryan PhD, a research dietitian at St. James’s Hospital, Dublin, designed the trial.

In a double-blinded, randomized control trial, patients awaiting esophagectomy surgery were randomly assigned to treatment and control groups. While both groups received a 240ml nutritional supplement twice daily starting five days before surgery (which was identical in calories, protein, micronutrients and flavor), patients in the treatment group received an enriched formula with omega-3 (2.2g EPA/day). Immediately following surgery, the supplement was given through a feeding tube for 14 days while patients recovered in hospital. Once patients could resume oral feeding, they continued drinking the supplement until 21 days post surgery.

The esophageal research group found that patients given the standard feed (without omega-3) suffered clinically severe weight loss post surgery—losing an average of four pounds of muscle mass—whereas in the omega-3 group patients maintained all aspects of their body composition.

“The results were extraordinary in the sense that no previous nutritional formulation had revealed such an outcome, with supplemented patients maintaining all aspects of their body composition in the three weeks following surgery. Patients given the standard supplement without omega-3 lost a significant amount of weight comprising 100 percent muscle mass. In fact, 68 percent of patients suffered ‘clinically severe’ weight loss post surgery in the standard group (without omega-3) versus only eight percent in the omega-3 group,” said Ryan. “The significant finding was that the patients did not lose just fat, as one would expect with weight loss, but instead they depleted their muscle stores significantly. Research has shown that a loss of five pounds of weight produces significant effects on quality of life and a patient’s ability to mobilize and perform simple activities of daily living. Losing four pounds of muscle is even more significant.”

Commenting in an accompanying editorial in the Annals of Surgery Dr. Michael Meguid, professor of surgery at State University of New York, noted: “This study is a significant step forward because it underscores the message to surgeons of the importance of using omega-3 based nutrition as an adjunct therapy started at least five days before surgery. It should no longer be a surgeon’s preference, but the standard of expected norm for the practice of elective complex gut cancer surgery.”

According to the Citizens for Health, the US Government Accountability Office (GAO) recently presented a report to Congress, entitled “Dietary Supplements: FDA Should Take Further Action to Improve Oversight and Consumer Understanding.”

With regard to this particular report, the GAO’s work was done at the request of Congressional Representatives Henry Waxman, John Dingell and Bart Stupak, and Senator Richard Durbin. Rep. Stupak has been one of the FDA’s most vocal critics, said Citizens for Health, and Reps. Waxman and Dingell, and Sen. Durbin have been skeptics of DSHEA and the dietary supplement industry for years.

According to Citizens for Health, the GAO organized its comments according to four themes:
•    The FDA has insufficient information from the industry about dietary supplements and manufacturing operations to be effective.
•    The FDA has applied insufficient resources to properly oversee dietary supplements.
•    The FDA has insufficient authority to remove products from the market.
•    The FDA needs to do more to educate the public about dietary supplements.

Within the GAO Report, Citizens for Health expressed concern with comments made, specifically the fact that the report cited over 50,000 adverse events each year related to the dietary supplement industry.

Citizens for Health demanded transparency concerning how the FDA arrived at this estimate, including how the FDA evaluates whether an adverse event was actually caused by supplements as opposed to other potential causes.

Ultimately the GAO made four recommendations:

•    Dietary supplement companies should be required to identify themselves as a dietary supplement company as part of the existing registration requirements, and they should be required to update this information annually; they should be required to provide a list of the products they sell and a copy of the labels, updated annually; and they should be required to report all adverse events related to dietary supplements, not just major events.
•    The FDA should issue guidance to clarify when an ingredient is considered a new dietary ingredient, the evidence needed to document the safety of new dietary ingredients and appropriate methods for establishing ingredient identity.
•    The FDA should provide guidance to the industry to clarify when products should be marketed as either dietary supplements or conventional foods formulated with added dietary ingredients.
•    The FDA should work better to educate consumers about the safety, efficacy and labeling of dietary supplements.

“CRN welcomes guidance from FDA on New Dietary Ingredients (NDI); in fact we’ve called on the Agency to be more transparent and issue this NDI guidance. The industry could potentially support registration of products assuming the details are not inappropriately burdensome and would not prevent beneficial products from being brought to market,” said Steve Mister, president and CEO, Council for Responsible Nutrition (CRN). “But regulations are only as strong as enforcement, and it is time for FDA to focus its energy and resources on inspections and enforcement actions directed at the small minority of companies that are giving those in the majority a black eye.  
 
“We disagree with the logic behind the recommendation of submitting all adverse event reports, versus the important need to submit serious adverse event reports,” he continued. “The Agency is already overburdened and understaffed, and we are opposed to creating more bureaucratic paperwork that would not result in true benefits for consumer safety. The adverse event reporting law was carefully considered and supported by numerous stakeholders, including consumer groups, and there is no need to revise a law that only recently went into effect and appears to be working.”

To view the report, visit http://www.gao.gov/new.items/d09250.pdf.

The results of a safety study to be published in the May issue of Food and Chemical Toxicology demonstrate that the probiotic strain, Bacillus coagulans, is safe for human consumption, even in massive amounts. This is an independent study using Ganeden Biotech’s (Mayfield Heights, OH) GanedenBC30 strain of probiotics.

Many experts recognize the health benefits of probiotics, but some have stressed that probiotic strains must first demonstrate safety before recommendations can be made about their widespread use, Ganeden said. The new study also sets the stage for the incorporation of GanedenBC30 into a wide variety of foods, the company said; unlike many other probiotic strains, GanedenBC30 easily survives the challenges of food manufacturing, extreme temperatures and the gastric environment.
 
Study data showed that administering GanedenBC30 to rats at nearly 100,000 times the recommended dose for humans produced no harmful effects. “The results we saw with GanedenBC30 were off the charts compared to what we see with other common food ingredients and nutrients used to fortify foods,” said Dr. John R. Endres, chief scientific officer of AIBMR Life Sciences and one of the authors of the study. “We saw safety factors ranging up to 95,000 times the typical dose. These types of numbers are unprecedented in toxicology studies of this type.”
 
“It was important to us to confirm the safety of consuming large amounts of GanedenBC30, since it may exist in several foods that might be consumed at the same time,” said Sean Farmer, Ganeden’s chief scientific officer.
  
“While Bacillus coagulans has always intrigued me as a probiotic strain due its ability to survive commercial conditions and gastric acidity, I didn’t know much about its safety and efficacy because there was little published data to review,” stated Dr. Gary B. Huffnagle, one of the leading researchers in the field of probiotics and author of The Probiotics Revolution. “Now that the studies are being published, it will be much easier to recommend it to consumers and to food manufacturers looking to enhance their foods with probiotics.”

For more information, call (440) 229-5200 or visit www.ganedenlabs.com.

Maker of the life’sDHA brand, Martek Biosciences Corporation (Columbia, MD) and Ragasa (Mexico), a provider of raw and refined oil products and maker of Mexico’s leading consumer cooking oil brand, Nutrioli, announced that they have entered into a long-term supply agreement.

Under the terms of the agreement, Ragasa has agreed to purchase all of its DHA omega-3 needs from Martek and plans to launch a consumer product featuring Martek’s flagship product, life’sDHA, in 2009. Ragasa will display the life’sDHA logo on the product packaging, and will also include the life’sDHA logo in related marketing, advertising and promotional materials.

“Martek’s life’sDHA is a trusted, vegetarian and sustainable source of DHA, an important nutrient for brain, eye and heart health throughout life,” said Alejandro García, Ragasa partner and general manager. “Ragasa is pleased to be working with Martek to bring this health-enhancing innovation to Mexican consumers.”

For more information on Martek Biosciences, call (410) 740-0081 or visit www.martek.com. For a complete list of life’sDHA products, visit www.lifesdha.com.

As part of its first national consumer education and marketing campaign, “Organic. It’s worth it,” the Organic Institute is conducting a search for its first-ever consumer ambassador to serve as spokesperson. Now through May 8, the Organic Institute is calling on everyday individuals (“No celebs allowed,” it said in a statement) nationwide to submit videos on YouTube explaining why they feel organic products are worth it. In addition to serving as the Organic Institute’s official spokesperson, the star of the winning video will receive a trip to the All Things Organic show in Chicago this June.

The Organic Institute’s board will consider the top 12 videos with the most views as the initiative’s program finalists. Then, the winning spokesperson will be unveiled at All Things Organic. In the meantime, retailers are invited to become “casting agents” and help the Institute find its idol. Retailers are invited to encourage customers and friends to enter, and share the contest in their newsletter, blog, social media outlets or on their website.

Visit www.OrganicItsWorthIt.com/GetInvolved for full contest details.

According to the Organic Consumers Association (OCA), The Food Safety Modernization Act, or HR 875, is a food safety bill that would require farms to have a food safety plan, allow their records to be inspected and comply with food safety regulations. As it is currently drafted, it could be applied to all farms, including certified organic and farm-to-consumer operations.

“For the record, Organic Consumers Association does have an alert on HR 875. Having said that, OCA supports aspects of HR 875 that call for mandatory recalls of tainted food, increased scrutiny of large slaughterhouses and food manufacturers, and hefty fines against companies that send poisonous food to market,” the association said in a statement. “The now discredited ultra-libertarian notion that companies or the market will regulate themselves is not only ludicrous, but dangerous, whether we are talking about the banking system or the food and farming sector.”

But the organic community is seemingly up in arms over this bill, especially in online forums and in the blogosphere.

“One fear being expressed by consumers about the bills now being proposed is that they will make it illegal to grow backyard gardens and it will be the death of organic farming,” expressed the Organic Trade Association (OTA), in an attempt to quiet the myriad of concerns voiced recently in the organic community with regards to HR 875. “The fact is that there is no language to regulate, penalize or shut down backyard gardens, nor to stop organic farming. The proposed Food Safety Modernization Act only addresses food safety issues under the jurisdiction of the US Food and Drug Administration. The National Organic Program is actually under the jurisdiction of the US Department of Agriculture.”

Additionally, OTA Executive Director Christine Bushway has announced OTA will be forming a Food Safety Task Force to thoroughly analyze the impact of any food safety legislation being proposed, and will advise the industry and governmental bodies on recommendations that promote and protect organic agriculture and products, and improve food safety.

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