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Chronic Toxicity Study Confirms Safety of Bio-Phase 2250™ Ingredient

KEARNY, NJ, NOV. 5, 2002-- Chronic Toxicity Study (L.D.50) demonstrated that Bio-Phase 2250™ , the first standardized white bean extract used in a variety of weight loss supplements, is safe and non-toxic.

Bio-Phase 2250™ showed no signs of chronic toxicity at doses up to 1.0 gm/kg body weight for up to 90 days,” said Ramadasan Kuttan, Ph.D., director, Amala Cancer Research Center, Thrissur, India, who conducted the study along with R. C. Srimal, M.D. “The data indicates that administration of Bio-Phase 2250™ for 90 days did not produce any adverse reaction as seen from the organ weight, necropsy, haematological values and biochemical values.”

Additional findings of the study were as follows:
• There was no significant weight changes in any of the animals.
• Food consumption in the Bio-Phase 2250™ groups (1 gm and 5 gm) was found to be   decreased significantly, especially after two months of treatment, compared to   controls.
• Liver function tests indicated that chronic administration of Bio-Phase 2250™ at the    doses given did not produce any change in the liver function tests such as GOT, GPT,    ALP, Bilirubin, total protein and Albumin/Globulin ratio.
• Chronic administration of the Bio-Phase 2250™ did not produce any change in the    renal function as indicated from serum urea, creatinine and electrolyte levels.
• Chronic administration of Bio-Phase 2250™ did not produce any change in the    haematological parameters such as total WBC, differential count and platelets.
• There was no change in necroscopy of the animals and organ weight of the animals    such as liver, kidney, spleen were unchanged.
• There was no significant change in the lipid profile of animals treated with Bio-Phase    2250™
• Histopathology of liver and kidney of the Bio-Phase 2250™ -treated groups was    normal and similar to controls.

An LD 50 study for acute toxicity, conducted earlier this year, also confirmed that
Bio-Phase 2250™ is “safe and non-toxic.”