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Patients with type 2 diabetes lose weight, decrease insulin in meal replacement trial

June 13, 2012 – A pilot study shows that a protein-rich meal replacement made from soy, yogurt, and honey (Almased®) helps patients with type 2 diabetes lose weight, gain better control of their blood sugar, and decrease their daily insulin dose.

Patients in the study also lowered their body mass index (BMI), waist and hip circumference, and fasting glucose levels, while improving their HDL-cholesterol and triglycerides. The results were reported at the American Diabetes Association's 72nd Scientific Sessions®.

"In light of the number of people with type 2 diabetes related to obesity, it's very important to investigate and explore any new tool that may have a positive effect on both weight and blood sugar," said Stephan Martin, MD, medical director of the West-German Diabetes and Health Centre in Düsseldorf, Germany, who conducted the study.

"One of the most interesting findings to us was that Almased's positive effect on blood sugar was independent of its effect on weight loss."

Significant changes were seen at 12 weeks in the various study outcomes measured:

• Average insulin dose decreased from 147 to 65 units per day (p<0.0001).
• Weight decreased an average of 23 pounds (9%, p<0.0001).
• Average HbA1c, which is an overall measure of how well blood sugar is controlled, decreased from 8.8% to 8.1% (p=0.048).
• Fasting glucose, which is a measure of blood sugar after an eight-hour fast, decreased an average of 27.6 mg/dL (p=0.027).
• BMI decreased an average of 2.6 kg/m2 (p<0.0001).
• Average waist and hip circumferences decreased 2.8 inches (p=0.0003) and 1.3 inches (p=0.035), respectively.
• Triglycerides decreased an average of 70.3 mg/dL (p=0.0001) while HDL-cholesterol increased 2.2 mg/dL (p=0.049).

While the formal study with Almased ended after 12 weeks, investigators followed up with patients after one and a half years. Four patients who continued to use Almased reported additional decreases in insulin doses, HbA1c, and weight. Two of these patients were able to stop insulin injections completely. The long-term use among some patients points to the ease of incorporating Almased into a daily dietary routine suitable for people with type 2 diabetes. A larger study of more than 300 patients is underway in Germany to confirm the findings of this pilot study. Both of these studies are sponsored by Almased-Wellness-GmbH.

"Some people will be surprised that patients could stop insulin completely; we need to change the thinking that once insulin is started there is no way to stop it," said Dr. Martin. "Motivated patients who are committed to long-term dietary changes and increased physical activity can make a real change in their weight and metabolic measures."

"The problem of obesity and type 2 diabetes is large and growing," said Silke Ullmann, MPH, RD, LDN, of Almased USA. "We are committed to studying Almased to see how it may help people lose weight and gain better control of blood sugar levels."

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Study Regimen

The pilot study enrolled 22 men and women with type 2 diabetes who were also obese. For the first week of the study, participants replaced all three daily meals with Almased. In weeks two through four, they replaced two meals and had a protein-rich lunch. For the last eight weeks of the study they only replaced one meal with Almased. Fifteen participants (68%) completed the study, a rate comparable to other diet-change studies.

About Type 2 Diabetes

About 26 million Americans have diabetes and type 2 is most common. In type 2 diabetes, either the body does not produce enough insulin or it does not use the insulin it produces properly. Insulin is necessary for the body to be able to use blood sugar for energy. It takes the sugar from the blood into the cells. When blood sugar levels build up in the blood instead of going into cells, it can lead to diabetes complications, such as high blood pressure and heart disease. Increased weight is a strong risk factor for type 2 diabetes. Almost 60 percent of Americans with type 2 diabetes are obese and nearly all of the rest are overweight.

About Almased

Almased is an all-natural meal replacement powder made from high-quality soy, yogurt, and honey. The unique formula contains no artificial flavors, fillers, added sugars, preservatives, or stimulants; it contains no genetically modified organisms and is gluten-free. Almased was developed in 1985 by noted German scientist and holistic therapist Hubertus Trouillé and has become the best-selling weight loss product in Germany.

Almased has been available in the US since 1998. The company is now headed by Hubertus's son, André Trouillé, who has fostered scientific research on Almased since 1999. This research has documented that unlike other supplements that simply suppress appetite, Almased improves metabolism and energy level, and helps the body burn fat while retaining muscle mass. Almased USA, Inc. is headquartered in St. Petersburg, FL.