The "Flint" study titled, "A Single-blind, Multi-site Trial of the Dietary Supplement Anatabine (RCP006) to Determine the Effects on Peripheral Markers of Inflammation in Patients with Elevated Levels of C-reactive Protein (CRP)", is a multi-site study of the safety, tolerability, dosing, and biological effects of the anatabine citrate used in Rock Creek Pharmaceutical's Anatabloc® product. Subjects in the study are individuals with high levels of C-reactive protein (CRP) in the blood, which is a marker of systemic inflammation in a number of common medical conditions. The subjects were screened for eligibility and then were studied for three months. In the first month they were given placebo, in the second month they were given the Anatabloc® supplement, and in the third month they were given placebo again. Blood samples were taken at the beginning of the study and also were taken after each treatment period. The blood samples were analyzed for CRP, anatabine, multiple markers of inflammation referred to as interleukins (cytokines), as well as routine clinical labs for safety. The intent of the study is to determine if the Anatabloc® supplement is helpful in lowering CRP.
The committee reviewing the data found that the administered doses of anatabine were safe, well-tolerated, and showed clear evidence of a biological effect on CRP and the immune system, as manifested by CRP and an inflammatory marker called Tumor Necrosis Factor Alpha (TNF-alpha). The committee also found a signal that the supplement may have an important effect in the most common form of adult onset diabetes. Anatabine citrate, the active ingredient in Anatabloc®, is found in common food plant species and is a natural compound that activates the Alpha7 nicotinic acetylcholine receptor. Alpha7 receptors are believed to be important in a number of inflammatory conditions, including the characteristic systemic inflammation seen in diabetes. 11 of 18 (61%) diabetic subjects on metformin had a CRP reduction, as did 31 of 81 (38%) subjects in the general trial population not taking metformin. Overall, 42 of 99 (42%) subjects had a decrease in CRP after only one month with anatabine supplementation.
Elevated CRP is predictive in other studies for the onset of both metabolic syndrome as well as overt diabetes, and elevated CRP is a significant risk factor for cardiovascular disease both in diabetics and non-diabetics. Lowering CRP would be strong evidence of a potential benefit in reducing the inflammatory component in adult onset diabetes, an epidemic problem in the United States.