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Studies

Study #1 - Animal (Rat) Study:
This study utilized a randomized placebo-controlled rat model for obesity and type 2 diabetes.
Relative to the findings of the control group on a high-fat diet:

• The animals in the active group (Mirafit) weighed less and had less body fat content.
• The animals in the active group had plasma triglyceride levels 30% lower (p<0.05) than the control group.
• Plasma leptin levels were lower (ρ<0.05) in the active group relative to the control group, indicating an increase in leptin sensitivity and therefore satiety. 
• Plasma insulin levels (p<0.09) and the insulin/glucose ratio (calculated insulin sensitivity, p<0.05) were lower relative to the control group indicating an increase in insulin sensitivity.
• Fecal fat excretion was increased in the active versus control animals.
• α-Cyclodextrin (Mirafit fbcx) bound and removed 9.4 times its own weight in dietary fat.
• The animals experienced no obvious adverse side effects.

Conclusions: Excess weight gain was prevented in the test group with a Mirafit fbcx level of 10% of that of the fat content of the diet. In the active vs. control groups: blood serum triglyceride and leptin levels were reduced, while the calculated insulin sensitivity and fecal fat excretion were increased. This study includes an in vitro study that confirms that Mirafit fbcx binds at least nine times its own weight in fat.
References:

• Brogan, K., Artiss, J., Brucal, M., Moghaddam, M., Jen, K-LC.  Effects of a New Soluble Dietary Fiber on Body Weight Regulation in Rats.  Obesity Research, 12;A110:2004.
• Artiss JD, Brogan K, Brucal M, Monghaddam M, Jen K-L C. The Effects of a New Soluble Dietary Fiber on Weight Gain and Insulin Sensitivity in Rats. Metabolism Clinical and Experimental, 55;195-202:2006.

Study #2 - Clinical Trial – Obese Type 2 Diabetics:
This study was a double blind, placebo controlled clinical trial with obese type 2 diabetic patients.
Relative to the findings of the control group, patients in the active group showed:

• In the absence of intense nutritional counselling, body weight gain was reversed.
• Blood triglyceride (ns), cholesterol (p<0.05) and LDL (bad) cholesterol (p<0.01) levels were reduced in those patients who began the study with elevated triglyceride levels.
• Blood HDL (good) cholesterol levels were increased but not significantly.
• Blood leptin levels were unchanged.
• Blood levels of adiponectin (p<0.05) were increased, indicating an increase in insulin sensitivity.
• Patients in the active group consumed more calories (p<0.05) and tended to have higher food efficiency, no more weight gain was observed.
• Based upon dietary recall data, Mirafit fbcx bound and eliminated 9.7 times its own weight in dietary fat.
• Patients who consumed higher saturated dietary fat diets demonstrated more marked effects.
• Nutritional counselling and rigid control of energy intake would further enhance the benefits of Mirafit fbcx.
• Higher doses of Mirafit fbcx may be required in those individuals with very high energy intake.
• No adverse side effects were reported.

Conclusions: Mirafit fbcx is effective in reducing and/or maintaining body weight in obese patients with type 2 diabetes- without either reduced energy intake or increased exercise program. Cholesterol and triglyceride levels were both reduced in patients who began the study with high triglyceride levels.  HDL (good) cholesterol levels were not significantly changed.  Significantly increased adiponectin levels indicate an increase in insulin sensitivity which may delay the onset of usage of insulin and/or reduce the amount of supplemental insulin required.  Mirafit fbcx binds and eliminates at least nine times its own weight in dietary fat.  There were no adverse side effects reported.
References:

• Grunberger G, Artiss JD, Jen K-LC. Beneficial Effects of a New Soluble Dietary Fiber FBCx™ in Obese Patients with Type 2 Diabetes. Diabetes, 54(Supl.1); A440:2005.
• Jen, K-LC., Grunberger, G., Artiss, J.  The benefits of early intervention in obese diabetic patients with FBCxÔ, a new dietary fiber.  Obesity Research, 13;A120:2005.
• Jen, K-L.C., Grunberger, G., and Artiss, J.  Interaction of FBCx™ and dietary fat in body weight regulation in obese patients with diabetes.  Obesity Research, 14;A167-8:2006.
• Grunberger G, Jen K-L C, Artiss JD. The Benefits of Early Intervention in Obese Diabetic Patients with FBCx™ - a New Dietary Fibre. Diabetes/Metabolism Research and Reviews, 22;56-62:2007.

Study #3 – LDLr-KO Mouse Study:
This mouse model randomized placebo-controlled study for the investigation of elevated blood lipids revealed the following- Relative to the control animals on a “Western” diet:

• There was no difference in body weight between the two groups.  This is not unexpected as this particular animal model is a blood lipid and not body weight model.
• There was no significant difference in the amount of food that the two groups consumed.

• The test group showed significant decreases in blood levels of total cholesterol and triglyceride levels trended lower.
• Total fatty acids were lower by 17%.
• Taken as a whole, the saturated and trans fats were 4.8% lower- but not quite significant.
• Expressed as a percentage of the total lipids, the saturated and the trans-fatty acids were all decreased while the unsaturated or omega fatty acids were increased.
• The proatherogenic apolipoprotein-B was significantly lowered due to a 29% decrease in the LDL, VLDL and IDL (bad) cholesterol fractions.
• No change in the atheroprotective HDL (good) cholesterol levels was observed.

Conclusions: The inclusion of α-cyclodextrin (Mirafit fbcx) in the Western diet of LDLr-KO mice demonstrated a lowering of the proatherogenic lipoproteins and trans-fatty acids by decreasing the ratio of saturated and trans-fatty acids to polyunsaturated fatty acids
(-5.8%).  The data suggests that α-cyclodextrin may be useful in maintaining a healthy cardiovascular system.

References:

• Wagner EM, Jen K-LC, Artiss JD, Remaley AT. Effects of FBCx on Lipid Lowering in LDLr-KO Mice. Federation of American Societies for Experimental Biology Journal, 21;A341:2007.
• Jen K-L C, Wagner EM, Artiss J, Remaley AT. α-Cyclodextrin specifically lowers plasma trans fatty acids in 3 mouse models. Obesity, 15;A184:2007.
• Wagner EM, Jen K-LC, Artiss JD, Remaley AT. Dietary alpha-cyclodextrin  lowers LDL-C and alters plasma fatty acid profile in LDLr-KO mice on  a high-fat diet. Metab. Clin. Expt., 57;1046-51:2008.

Study #4 – Fecal Fat Excretion Rat Study:
This study focused on an animal model for the investigation of fecal fat excretion.
The findings include:

• Relative to cellulose (vegetable fiber) α-cyclodextrin (Mirafit fbcx) had no effect on unsaturated fat excretion.

• α-Cyclodextrin is more effective than chitosan at binding and eliminating saturated dietary fats.

Conclusions: α-Cyclodextrin preferentially binds and eliminates saturated fats
References:

• Gallaher DD, Gallaher CM, Plank DW. Alpha-Cyclodextrin Selectively Increases Fecal Fat Excretion of Saturated Fats. Federation of American Societies for Experimental Biology Journal, 21;A730:2007.

Study #5 - Glycemic Response Clinical Trial:
Thisdouble blind, randomized, cross-over study examined the effects of Mirafit fbcx on blood insulin and glucose levels, following a zero fat high carbohydrate meal.
The findings include:

• Mirafit fbcx significantly lowered blood glucose levels following a high carbohydrate meal.
• Blood insulin levels were not affected.
• Mirafit fbcx increased satiety.
• The volunteers did not like the taste of the rice/α-cyclodextrin mixture.
• In the absence of fat, α-cyclodextrin caused minor gastrointestinal discomfort.

Conclusions: Adding 5g of α-cyclodextrin to a 50g meal of digestible carbohydrate can significantly reduce postprandial glucose levels.
References:

• Buckley, JD, Thorp AA, Murphy KJ, Howe PRC. Dose-Dependent Inhibition of the Post-Prandial Glycaemic Response to a Standard Carbohydrate Meal following Incorporation of Alpha-Cyclodextrin. Annals of Nutrition and Metabolism, 50;108-114:2006.

Study #6 – Overweight but not Obese Clinical Trial:
This was a 2-month, double-blinded, placebo-controlled, crossover clinical trial with overweight but not obese (BMI between 25 and 30 kg/m2) and otherwise healthy individuals.  The findings revealed that during the active phase of the study:

• Volunteers lost weight without changing their diet or exercise regime.
• No significant differences in fasting glucose, leptin, adiponectin, high sensitivity c-Reactive protein, body composition, HDL (good) cholesterol or triglyceride blood levels were observed.
• Significant decreases in total and LDL (bad) cholesterol, apolipoprotein-B and insulin were observed.
• The higher the baseline values of either total cholesterol or triglycerides the greater the decrease in total cholesterol values.
• A decrease in insulin levels of 9.5% without any change in glucose levels suggests increased insulin sensitivity.

Conclusions: Mirafit fbcx (6 tablets per day), without changes to diet or lifestyle caused weight loss, reduced cholesterol and atherogenic lipoproteins as well as increased insulin sensitivity in healthy overweight volunteers.
References:

• Kasim-Karakas, S., Comerford, K., Gurusinghe, D., Almario, R., Artiss, JD, Jen, K-L C.  The beneficial effects of α-cyclodextrin on blood lipid profile in healthy humans.  Obesity, 17:S270, 2009.
• Comerford K, Artiss JD, Jen K-L C and Kasim_Karakas S. The beneficial effects on blood lipids and weight loss in healthy humans. Obesity.

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.