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New Animi-3 Clinical Trial
PBM Pharmaceuticals,
the maker of Animi-3, is conducting a new study for cardiovascular risk reduction
and dementia by a leading heart disease specialist. The Animi-3 clinical study
is a six-month, double-blind, randomized, placebo-controlled trial in 75 subjects
ages 55-80 years with no prior history of dementia.
The study started in September 2005 and is being conducted by Ernst J. Schaefer,
M.D., of Cardiovascular Research Associates, in Boston, MA. Dr. Schaefer is also
a Professor of Medicine at Tufts University School of Medicine.
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“Increased Consumption of Omega-3 Fatty Acids May Lower the Risk of
Cardiovascular Disease, Dementia, and Inflammatory Disease” Conference, July 1,
2004. Supported by PBM educational grant.
* FDA “Qualified Health Claims” B vitamins & Vascular Disease. As part of a
well-balanced diet that is low in saturated fat and cholesterol, Folic Acid, Vitamin
B6 and Vitamin B12 may reduce the risk of vascular disease. FDA evaluated the above
claim and found that, while it is known that diets low in saturated fat and cholesterol
reduce the risk of heart disease and other vascular diseases, the evidence in support
of the above claim is inconclusive.
Docket No. 99P-3029.
FDA “Qualified Health Claims” Omega-3 Fatty Acids & Coronary Heart Disease.
Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.
FDA evaluated the above claim and determined that, although there is scientific
evidence supporting the claim, the evidence is not conclusive.
Docket No. 9IN-0103.
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