I NTRODUCTION

What is Lipo Ease™?

Lipo Ease™ is a dietary supplement containing the naturally occurring soluble fiber alpha-cyclodextrin, patented as FBCx®. It has been shown to provide support for weight management, healthy lipid levels, and glucose tolerance. FBCx® is a cyclic oligosaccharide with a truncated cone shape that efficiently complexes dietary fats within its conical structure. While typical dietary fibers adhere to dietary fat in an approximate 1:1 ratio, FBCx® has demonstrated an impressive fat-complexing capability of up to 1:9.

Two tablets of Lipo Ease™ may be taken with meals or snacks three times per day. Each serving of Lipo Ease™ provides 2 grams of FBCx®, which sequesters up to 18 grams of dietary fat (equal to about 162 calories). When taken as directed, Lipo Ease™ can prevent the absorption of up to 486 dietary calories per day. The FBCx®-fat inclusion complex passes through the digestive tract without being absorbed and is eliminated without unpleasant side effects.

How much dietary fat is prevented from being absorbed when taken as directed?

Each two-tablet serving of Lipo Ease™ sequesters up to 18 grams of dietary fat (equal to about 162 calories) preventing its digestion and absorption. While typical dietary fibers adhere to dietary fat in an approximate 1:1 ratio, FBCx® has demonstrated an impressive fat-complexing capability of up to 1:9. When taken as directed, Lipo Ease™ can prevent the absorption up to 486 dietary calories per day.

Does Lipo Ease™ treat all fats equally?

Animal studies suggest Lipo Ease™ may have a greater sequestering affinity for saturated fats and trans fatty acids. Regulatory reviews of the FBCx® alpha-cyclodextrin in Lipo Ease™ conclude that it is unlikely to impair absorption of fat-soluble vitamins and medications. In one human study, it had no effect on serum vitamin D3 levels.

Does diet need to be altered when taking Lipo Ease™?

Lipo Ease™ can be safely added to a balanced and nutritious diet. Two tablets of Lipo Ease™ may be taken with meals or snacks three times per day. Best supportive results will be observed when Lipo Ease™ is combined with a sensible calorie-restricting diet and exercise program.

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What is Lipo Ease™?

Lipo Ease™ is a dietary supplement containing the naturally occurring soluble fiber alpha-cyclodextrin, patented as FBCx®. It has been shown to provide support for weight management, healthy lipid levels, and glucose tolerance. FBCx® is a cyclic oligosaccharide with a truncated cone shape that efficiently complexes dietary fats within its conical structure. While typical dietary fibers adhere to dietary fat in an approximate 1:1 ratio, FBCx® has demonstrated an impressive fat-complexing capability of up to 1:9.

Two tablets of Lipo Ease™ may be taken with meals or snacks three times per day. Each serving of Lipo Ease™ provides 2 grams of FBCx®, which sequesters up to 18 grams of dietary fat (equal to about 162 calories). When taken as directed, Lipo Ease™ can prevent the absorption of up to 486 dietary calories per day. The FBCx®-fat inclusion complex passes through the digestive tract without being absorbed and is eliminated without unpleasant side effects.

How much dietary fat is prevented from being absorbed when taken as directed?

Each two-tablet serving of Lipo Ease™ sequesters up to 18 grams of dietary fat (equal to about 162 calories) preventing its digestion and absorption. While typical dietary fibers adhere to dietary fat in an approximate 1:1 ratio, FBCx® has demonstrated an impressive fat-complexing capability of up to 1:9. When taken as directed, Lipo Ease™ can prevent the absorption up to 486 dietary calories per day.

Does Lipo Ease™ treat all fats equally?

Animal studies suggest Lipo Ease™ may have a greater sequestering affinity for saturated fats and trans fatty acids. Regulatory reviews of the FBCx® alpha-cyclodextrin in Lipo Ease™ conclude that it is unlikely to impair absorption of fat-soluble vitamins and medications. In one human study, it had no effect on serum vitamin D3 levels.

Does diet need to be altered when taking Lipo Ease™?

Lipo Ease™ can be safely added to a balanced and nutritious diet. Two tablets of Lipo Ease™ may be taken with meals or snacks three times per day. Best supportive results will be observed when Lipo Ease™ is combined with a sensible calorie-restricting diet and exercise program.

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SAFETY, SIDE EFFECTS & DRUG INTERACTIONS

Does Lipo Ease™ contain allergens?

Lipo Ease™ is free of the following common allergens: milk/casein, eggs, fish, shellfish, tree nuts, peanuts, wheat/ gluten, yeast, and soybeans. It does not contain artificial colors, flavors, or preservatives.

Does Lipo Ease™ contain stimulants?

No, Lipo Ease™ is stimulant-free.

Are there any negative reactions to Lipo Ease™?

When taken as recommended – 2 tablets with meals or snacks three times per day with adequate intake of water – no negative effects have been reported.

Are there any side effects?

Lipo Ease™ (FBCx®) prevents dietary fat absorption by surrounding and sequestering the fatty acid tails of di- and triglycerides within its conical structure. Lipo Ease™-fat inclusion complex cannot be broken down by human digestive enzymes and so it passes through the small intestine unabsorbed into the colon. Microbial alpha-amylases hydrolyze FBCx® in the colon and both FBCx® and the triglycerides are largely fermented by the colonic microbiota. Unlike lipase inhibitors, Lipo Ease™ does not cause excessive fat in the stool (steatorrhea).

Are there adverse reactions or drug interactions?

None reported when taken as directed.

Is Lipo Ease™ safe to take when pregnant or nursing?

We do not recommend pregnant or nursing women take Lipo Ease™.

Should a high-fiber diet be avoided while taking Lipo Ease™?

Other fibers are not efficacious in complexing dietary fat. Therefore, there is no need to avoid a high-fiber diet. Lipo Ease™ with FBCx® can be counted as part of your daily fiber intake. Each serving contains 2 grams of fiber.

Has Lipo Ease™ been approved by the FDA?

The FDA has designated the GRAS (Generally Recognized As Safe) status to FBCx® alpha-cyclodextrin, supplied in Lipo Ease™.

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RESEARCH & CLINICAL TRIALS

How are the benefits of Lipo Ease™ verified?

FBCx® was patented by two professors from the Department of Nutrition and Food Science and Department of Pathology of Wayne State University in Detroit, Michigan. A research project involving an obese animal model identified that one gram of FBCx® sequesters and eliminates 9 grams of dietary fat. It also showed the beneficial effects of FBCx® on body weight management, as well as improved glycemic control. These beneficial effects were later verified in clinical trials with overweight healthy adults.

Are there clinical trials that show Lipo Ease™ supports healthy weight?

Yes. In one trial, 66 obese diabetic subjects were randomized to take two 1-gram tablets of Lipo Ease™ (FBCx®) or placebo with every fat-containing meal and followed for three months. All participants had been gaining weight at the rate of 2.2 ± 0.88 lbs per month before entry into the study. People who received Lipo Ease™ stabilized their weight while those on placebo continued to gain weight. When weight change was normalized for dietary energy intake, people receiving Lipo Ease™ lost weight. The most weight loss occurred in people consuming Lipo Ease™ in conjunction with reduced energy intake. Lipo Ease™ had less impact on weight in diabetics taking insulin although it still reduced daily energy intake by 237 calories as compared to 522 calories for noninsulin users. In a double-blind, crossover study involving 41 healthy, but overweight adults, Lipo Ease™ (FBCx®) alone facilitated significant weight loss over two months without diet or exercise. Although none of the participants reduced their energy intake, people receiving Lipo Ease™ lost on average a little less than 1 lb during the treatment period compared to controls.

Do clinical trials show that Lipo Ease™ aids healthy lipid levels?

The effect of Lipo Ease™ on serum lipid levels is largely dependent on whether dyslipidemia is present. In the clinical trial involving diabetics, Lipo Ease™ significantly lowered cholesterol levels if hypertriglyceridemia was present. The decrease in total cholesterol was attributable to a reduction in low density lipoprotein (LDL) cholesterol. No change in HDL-cholesterol was observed. Fasting serum triglycerides were reduced in people not using insulin although the change did not attain statistical significance.

In the study of healthy, but overweight adults, Lipo Ease™ significantly lowered total cholesterol and LDL-cholesterol levels in subjects with hypercholesterolemia and hypertriglyceridemia. It also effectively reduced circulating apolipoprotein B, a lipoprotein strongly associated with atherosclerotic vascular plaque and coronary heart disease. In a study of 34 individuals, 2 grams of Lipo Ease™ significantly lowered postprandial triglycerides following a standardized meal. Elevated nonfasting triglycerides are an independent risk factor for ischemic heart disease and death. Animal studies suggest Lipo Ease™ may have a greater sequestering affinity for saturated fats and trans fatty acids.

What effect did Lipo Ease™ have on glucose tolerance and insulin sensitivity in the clinical trials?

Lipo Ease™ has a dose-dependent effect on glucose tolerance and insulin sensitivity. When taken by healthy people with 50 grams of digestible starch, 5- and 10-gram doses reduce the incremental area under the curve (iAUC) for postprandial glucose. A 2-gram dose also flattened the glucose iAUC, although there were too few subjects to reach statistical significance.

Studies show that cyclodextrins complex and inhibit pancreatic alpha-amylase indicating a mechanism whereby Lipo Ease™ can reduce postprandial glucose loads. Among healthy, but overweight people, Lipo Ease™ decreased insulin levels by nearly 9.5% consistent with improved insulin sensitivity. In people with obesity and diabetes, Lipo Ease™ increases adiponectin levels especially in those not using insulin. Higher adiponectin levels favorably impact insulin tolerance, glucose regulation, and weight reduction.