Ebook A Randomized, Double-blind, Placebo –controlled trial of a new weight-reducing agent of natural origin
Even if considerable resources have been used to fight the obesity epidemic we see in most countries the results have been disappointing. The only effective measure in the long run are changes in food intake and physical exercise, but a number of agents drugs or natural substances, are available to help in initiating weight reduction. These agents can be used in combination with sustained changes of food intake and exercise habits.
A balanced diet involves the balanced intake of carbohydrates, fat and proteins.
Carbohydrates generally represent about 55% of calorie intake, compared with 30%
as fat and only 12% as proteins. Nutritional experts recommend that the fat intake is restricted to less than 30% of the daily energy intake, in order to improve cardiovascular health and avoid weight problems. Carbohydrate intake should also be monitored. Where the level of carbohydrates exceeds the body’s requirements, insulin converts the carbohydrate into fat which leads to weight gain. Lack of physical exercise or activity adds to the problems associated with a high-calorie diet. Low –carbohydrate diets are restrictive in terms of food choices, are hard to manage and are inevitably hard to adhere to. Exercise, unless carried out regularly, has little effect on weight control (1-4). Thus there is a need for alternative means of weight control.
Carbohydrates can vary in composition from simple monosccharides as glucose and
fructose through disaccharides as sucrose to complex polysaccharides as different
types of starches. In order for the body to utilize the different carbohydrates as energy, the molecules have to be made bioavailable e.g. transformed into to simple monosaccharide. These processes are dependent on different enzymes such as
amylase (for starch) and sucrase (for sucrose). Sucrase, as an example, is the name given to a number of enzymes that catalyze the hydrolysis of sucrose to fructose and glucose. It is often called invertase.These two monosaccharides (glucose/fructose) are absorbable by the gut and thus bioavaiable and be utilized as an energy resource by the body.
A number of natural ingredients contain substances that can inhibit the above
mentioned enzymes. Extracts of beans (Phaseolus Vulgaris) and hibiscus (Hibiscus
sabdariffa) contain substances that can block the transformation of complex starch molecule into absorbable carbohydrates so-called enzyme inhibitors.
If one in addition to blocking the transformation of starch molecules with amylase inhibitors from Hibiscus and Phaseolus also blocks the transformation of sucrose to absorbable sugar by using l-arabinose one can reduce the energy intake from carbohydrates considerably.
There is considerable evidence that the obesity epidemic is caused by a hormonal
phenomenon, specifically by the consumption of refined carbohydrates, starches and sugars, all of which prompt (sooner or later) excessive insulin secretion. Insulin is the primary regulator of fat storage. When insulin levels are elevated fat accumulates in our body tissue; when they fall fat is released and we use it for fuel. By stimulating insulin secretion, carbohydrates make us fat; by driving us to accumulate fat ,they increase hunger and decrease the energy we expend in metabolism and physical activity. In short, obesity is caused not by overeating or sedentary behavior, but by hormonal malfunctioning triggered by the onsumption of particular types of carbohydrate containing foods.
A small number of drugs has been registered and approved for treatment of obesity. Orlistat (Alli®) has lately been approved by the EU authorities as an OTC (Over The Counter Drug). Alli® contains 60 mg orlistat as compared to 120 mg in the prescription drug Xenical®. The effects of another drug (Rimonabant (Acomplia®)) have been rather disappointing and it has also been reported severe side-effects (4) which made it necessary to suspend the drug from the EU/EES markets. However, New drugs are under going clinical studies with promising results (5).
A new dietary formulation comprising natural ingredients, which work together to
capture excess sugar and reduce or prevent their changes the carbohydrate storage
in the body as fat, has recently been developed. This formulation overcomes the
problem of low carbohydrate diets since it changes carbohydrate absorption without the need of drastic changes in diet.
Previous studies have been performed with tablets containing an ?-amylase inhibitor extracted from kidney beans (Phaseolus vulgaris)(6). The clinical results from these studies with respect to weight reduction have indicated a weight reducing effect but in some of the studies the effect did not reach statistical effect as compared to placebo We have carried out a controlled clinical study of the activity and tolerability of the product in overweight and obese people.
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