NEW YORK, NY--(Marketwire -03/29/12)- The FDA is close to approving the first weight loss drug since Roche Holding AG's Xenical in 1999. Obesity treatment manufacturers may need to study the heart risks of their medicines before U.S. regulators weigh approval, Food and Drug Administration staff said in a report. The Paragon Report examines the outlook for companies in the Biotechnology Industry and provides equity research on VIVUS, Inc. (NASDAQ: VVUS - News) and Orexigen Therapeutics, Inc. (NASDAQ: OREX - News). Access to the full company reports can be found at: http://www.paragonreport.com/VVUS http://www.paragonreport.com/OREX

Vivus Inc., Orexigen Therapeutics Inc. and Arena Pharmaceuticals Inc. are in a race to bring the first weight loss pill to the market in 13 years.

An advisory panel will hold a hearing on the drugs in Silver Spring, Maryland, starting March 28. The FDA is not required to follow the panel's recommendations. The potential approvals come 15 years after the fen-phen appetite-suppression drug combination had to be pulled from pharmacies when it was linked to heart valve abnormalities. The advisers will consider whether "obesity drugs without a theoretic risk or signal for" cardiovascular harm "should be required to rule out" some level of cardiovascular risk before approval, the FDA said in the report.

The Paragon Report provides investors with an excellent first step in their due diligence by providing daily trading ideas, and consolidating the public information available on them. For more investment research on the Biotechnology Industry register with us free at http://www.paragonreport.com and get exclusive access to our numerous stock reports and industry newsletters.

Vivus' Qnexa is a controlled-release formulation that combines low doses of two older generic drugs: the stimulant phentermine, which cuts appetite, and topiramate, which increases the sense of feeling full. Topiramate is also sold under the brand name Topamax by Johnson & Johnson to treat migraines and seizures.

In their most recent financial results, for the three months ended December 31, 2011, Orexigen reported a net loss of $4.3 million, or $0.09 per share, as compared to a net loss of $11.3 million, or $0.24 per share, for the fourth quarter of 2010. As of December 31, 2011, Orexigen had $101.7 million in cash and cash equivalents and an additional $45.8 million in marketable securities, for a total of $147.5 million.

The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at http://www.paragonreport.com/disclaimer

More here:
VIVUS, Inc. and Orexigen Therapeutics, Inc. Await FDA Approval for Weight Loss Drugs

Although some diets may be easier for you to stick to or be more satiating, the bottom line is that you need to eat less to reduce body weight.

Africa Studio/Shutterstock

One problem in studying the effects of dietary composition is that it is not possible to vary the proportion of one component without changing the others. At the extremes of weight-loss diets, the Atkins and South Beach diets are low carbohydrate but high fat, while the Ornish diet is low fat, high carbohydrate [1]. To compare the effects of such diets outside metabolic wards, researchers must deal with study subjects whose dietary and other behaviors are not easily controlled.

Investigators do everything they can to encourage compliance with study protocols. But they confront a major challenge: Telling free-living people what you want them to do does not necessarily mean that they will follow your instructions or tell you the truth about what they are eating. And you have no easy way of getting around this problem. Because dietary intake methods all depend on accurately disclosing what subjects consume -- something impossible for most people to do -- the lack of an easy way to measure true calorie consumption in weight control studies must be considered "the fundamental flaw of obesity research [2]."

But that's not the only problem. When conducting clinical trials that compare one diet to another, researchers also face challenges in enrolling enough study subjects to satisfy statistical requirements, getting study subjects to stick to the prescribed diets, and retaining participants in the study throughout its length. Furthermore, clinical trials of diet and weight loss are expensive to conduct, and few are able to last long enough to observe whether initial weight losses were regained. These considerations make it especially difficult for investigators to evaluate the results of dietary studies objectively and for others to interpret the significance of the findings. Keep these caveats in mind as we take a look at some of the studies attempting to find out whether varying the proportions of protein, fat, and carbohydrate makes any difference to weight loss in real life.

LOW-FAT (AND, THEREFORE, HIGH-CARBOHYDRATE) DIETS

Atwater Values indicate that fat has more than twice the energy value of either protein or carbohydrate. It makes sense to think that cutting down on fat would help with weight maintenance or loss. In the United States the various editions of the Dietary Guidelines have long promoted lower-fat diets: "Avoid too much fat" (1980, 1985), "Choose a diet low in fat" (1990, 1995), "Keep total fat intake between 20 to 35 percent of calories" (2005), and "Reduce intake of solid fats" (2010). The more recent editions have focused on limiting saturated fat and cholesterol intake rather than total fat per se in recognition of the potential role of these components in heart disease risk. But the newer guidelines also recognize that from the standpoint of body weight, calories from fat are no different from calories from any other source.

This is a shift from the earlier recommendations that reshaped the marketplace. In the early 1990s, advice to reduce fat intake was all that food companies needed to hear to start making low-fat versions of many common foods -- low-fat cheese, mayonnaise, and peanut butter, for example -- along with oxymoronic products such as fat-free half-and-half and fat-free (but equally caloric) cookies. Such products are not necessarily healthier than the products they replace, and rarely taste as good.

But the relationship of dietary fat to obesity is still of much interest. For one thing, it takes hardly any energy to store excess fatty acids as body fat, whereas it takes a bit more energy to make fatty acids from excess dietary carbohydrate. For another, proponents of low-fat diets cite experimental observations demonstrating a connection between fat intake and overweight:

Some experts, however, view such evidence as not at all specific to fat, as it could just as easily relate to high-calorie diets from any source. Low-fat diets are necessarily high in carbohydrate -- the calories have to come from something. The range of protein is diets is typically 10 percent (low) to 20 percent (high) of calories; it can't be more, because foods are low in protein -- we don't need much. The real issue in real diets is carbohydrate v. fat. Few studies of such difference control for calories. Overall, studies of dietary patterns typically find no association between either the amount or the type of fat in the diet and subsequent weight gain over periods of several years [4].

Visit link:
Why Calories Count: Do Some Diets Work Better Than Others?

Dave Rice, March 29, 2012

A local company has begun marketing a snack food it describes as the worlds first family friendly weight loss gummies.

Gummy Owls are marketed by Green Forest Nutrition, makers of a blood-sugar stabilizer called Glucocil. Right now the product is only sold through the companys website, though company founder Lee Zhong told the San Diego Business Journal that he hopes to see them sold at GNC stores in the near future.

Green Forest says that Gummy Owls are made from a yam super fiber called konjac mannan, are sweetly flavored and clinically proven to safely reduce body weight and fat in adults and children (ages 12 and up). The company boasts that konjac mannan is the only dietary fiber approved for weight loss by the European Food Safety Authority, an agency of the European Union. Eating at least nine of the gummies a day while following what the promoters describe as a Eat Right, Be Active, Have Fun lifestyle is claimed to result in weight loss of a pound per week.

Read the original:
Comments

Published: March. 28, 2012 at 11:45 AM

SAN DIEGO, March 28 (UPI) -- Green -- unroasted -- coffee beans might be the weight-loss pill that has been sought for so long, a U.S. researchers suggested.

Joe Vinson of the University of Scranton in Pennsylvania and colleagues said the study involved 16 overweight or obese people ages 22-26, who took capsules of the extract or capsules containing a placebo, an inactive powder, for a total of 22 weeks.

The low dose consisted of 700 milligrams of the coffee extract, and the high dose was 1,050 mg. This "cross-over" study cycled participants through the two doses and the placebo, each for six weeks. Such studies have advantages because each person serves as his or her own "control," improving the chances of getting an accurate result, Vinson explained.

"The study participants' calories, carbohydrates, fats and protein intake did not change during the study, nor did their exercise regimen change," Vinson said.

Participants lost an average of 17 pounds during the 22 weeks of the study -- an average of a 10.5 percent decrease in overall body weight and a 16 percent decrease in body fat.

"Based on our results, taking multiple capsules of green coffee extract a day -- while eating a low-fat, healthful diet and exercising regularly -- appears to be a safe, effective, inexpensive way to lose weight," Vinson told the American Chemical Society symposium in San Diego.

Vinson said the green coffee beans' effects were likely due to chlorogenic acid, which is present in unroasted coffee beans.

Here is the original post:
Weight loss in a pill contains coffee bean

A worker inspects unroasted coffee beans on August 8, 2009 near Carmo de Minas, Brazil.

The study, which gave participants a supplement containing green coffee extract, was presented at the American Chemical Society (ACS) in San Diego and published earlier this year in Diabetes Metabolic Syndrome and Obesity.

PICTURES: Coffee and your health

The new study involved 16 overweight people (with Body Mass Indexes between 25 to 30) between the ages of 22 to 46 years old. They were monitored for 22 weeks, in which they were given a low dose 700 mg green coffee extract tablet, a high dose 1,050 mg extract tablet and a placebo. Because they were given all the different doses and the inactive placebo, the participants acted as their own control group.

Participants were told to take three green coffee capsules each day, 30 minutes before each meal with lots of water, due to the pill's bitterness. Roasting coffee makes beans less bitter, according to the researchers. The pill contained caffeine, but it amounted to about half a cup of coffee a day.

All the participants were monitored for their overall diet and exercise. Throughout the study, participants ate on average 2,400 calories a day and had a calorie expenditure of 400 calories, nowhere near the levels required for weight loss.

What effects did green coffee have?

After the study, participants lost an average of 17 pounds, which broke down to a 10.5 percent decrease in overall body weight and a 16 percent decrease in body fat. Lead researcher Dr. Joe Vinson, a professor of chemistry at the University of Scranton in Pa., said in an emailed press release that the weight loss may have been more, but since the subjects received a lower dose and placebo at some point in the study it may have lessened the overall effect. The study was funded by Applied Food Sciences, which makes green coffee supplements.

Vinson told HealthPop that the most exciting fact about this study was that the green coffee extract GCA did not have any side effects. Unlike other weight loss pills that have been pulled off the market by the FDA over health concerns or cause unpleasurable side effects like gastrointestinal problems, green coffee had no related problems, he said. "I've been taking some myself to see if caused any problems," Vinson told HealthPop. "It's okay."

The study also reported a two beats-per-minute reduction in heart rate among participants. Vinson told HealthPop while he doesn't recommend people who have high blood pressure forgo prescribed medicine for green coffee, it may help.

Original post:
Green coffee beans may lead to weight loss, study shows

Supplement Linked to Weight Loss in Small, Early Study

March 28, 2012 -- Ground green coffee beans, taken daily, seem to spur steady weight loss, according to new research.

In a small, 22-week study, researchers found that 16 overweight men and women lost an average of 17 pounds. They took the green (unroasted) coffee beans in supplement form and, for comparison, took a placebo at a different point of the study.

They did not change their diet. They were physically active. They lost more while on the supplements than while on placebo. They lost the most when on the higher of two coffee bean doses.

"We don't think it's the caffeine in it," says Joe Vinson, PhD, professor of chemistry at the University of Scranton.

He presented the findings Tuesday at the annual meeting of the American Chemical Society in San Diego. The results echo those of earlier studies, but Vinson used a larger dose of the green coffee beans.

The study included people 22 to 46 years old. It was funded by Applied Food Sciences, which makes the green coffee antioxidant supplement.

The results are interesting, but the study was small and short, so further study is needed, says Connie Diekman, RD, director of university nutrition at Washington University in St. Louis. She reviewed the findings for WebMD.

Vinson and his colleagues gave the men and women in the study a 700-milligram (mg) dose of the ground coffee beans and a 1,050 mg dose. They also gave them a placebo or inactive dose during the 22-week study.

The men and women cycled through each phase for six weeks. In between, they had ''wash-out'' periods where they didn't take any supplement. In this way, they served as their own comparison group.

Read this article:
Green Coffee Beans May Aid Weight Loss