According to a press release, the multi-centre, single-blind clinical trial took place at four different hospitals and medical research centres between late 2014 and early 2015. Healthy overweight men and women aged between 18 and 65 were divided into two groups: a treatment group and a control group taking a placebo. Apart from being overweight with a BMI between 26 and 35 at the start of the trial, nobody taking part was suffering from any serious health conditions or was pregnant.
The 64 people in the treatment group were given five capsules per day, each containing 500 mg of the ingredient. They took one capsule in the morning, two 15 minutes before lunch and two more 15 minutes before dinner. The 32 people enrolled in the control group followed the same procedure but their capsules contained a placebo. Besides these requirements, everyone continued with their regular diet and exercise patterns and all the participants kept a diary to record their experiences and encourage compliance. Out of 96 people enrolled, a total of 86 people completed the study.
The researchers observed a statistically significant gradual reduction in bodyweight in the treatment group throughout the study, compared with a baseline measured at the start. In contrast, there was no statistically significant change in the body weight of the group who received the placebo. Overall, the subjects in the treatment group lost 3.2 kg of their body weight on average over 90 days, compared with the baseline. The researchers also observed statistically significant reductions in average body fat, as well as in the upper abdominal, hip and waist circumference of people consuming the ingredient.
Francois Luthers, sales & marketing director, KitoZyme, said: “The results of this study, which will be published shortly in a peer-reviewed journal, demonstrate the clear benefits of KiOnutrime-CsG and the significant potential it offers in weight management applications globally.”
Produced by KitoZyme at its manufacturing facility in Belgium, the ingredient works by safely preventing some of the fat in food from being absorbed by the body. It is a cationic (positively charged) biopolymer that binds with anionic (negatively charged) molecules such as fats and fatty acids, and obstructs the emulsification and absorption of cholesterol. Taken just a few minutes before a meal, the ingredient will bind dietary fat in the stomach to form a gel that is later excreted naturally without being absorbed. A previous study carried out using a lab-based model of the human gut showed that the ingredient can bind 42% of the fats ingested in a typical meal.
The ingredient is an animal-free chitosan that is completely odourless and tasteless, making it suitable for a range of applications. It dissolves in just 10 minutes in the acidic environment of the stomach. This means that a dose can be administered almost immediately before a meal, making it convenient and easy for consumers to remember to take. Most other fat binding agents need to be taken up to 30 minutes before a meal, which makes compliance more difficult.
