Proactol

Clinical Studies of Proactol

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Confidential: This document contains information that is the confidential and proprietary property of InQpharm. Neither this document nor the information
therein may be reproduced, used or distributed to or for the benefit of any third party without the prior written consent of InQpharm.

Summary Of Pilot Clinical Study Of a Patented Fibre Complex of Opuntia Ficus
Indica On Fat Binding
Purpose:
This clinical study was aimed at observing the effects of a patented fibre complex from
Opuntia ficus indica on fat binding. The patented complex has a fibre content that is on
average eleven times higher than generic extracts from the same plant.
Ten healthy volunteers (5 women and 5 men with a Body Mass Index of 23.3 kg/m2; standard
deviations 3.1) participated in a mono-centric double-blind placebo-controlled crossover study.
Methods:
The test participants were randomly divided into two groups, one receiving the test material
(patented fibre complex of Opuntia ficus indica) and one receiving placebo. All the volunteers
consumed 1.6g of test material per meal; during one week and placebo during the same time
with a washout period between these two test periods.
A strict, standardised meal diet was observed by the volunteers to ensure a standardised intake
of lipids. The effect of the product dose in intestinal absorption was evaluated by measuring
steatorrhea in 3-day-old faeces, at the end of the two 7-day product consumption periods.
Results:
The quantity of fat content excreted compared to the quantity ingested increased on average
by 27.4% in-group volunteers with the dose of test material compared with the placebo. No side
effects or particular discomfort were observed with the dose of test material.
The results indicate the patented fibre complex from Opuntia ficus indica affects the
assimilation of fat following a heavy meal and causes an increase in elimination of fat in faeces
in subjects having a normal BMI (Body Mass Index).
Conclusion:
These results suggest effectiveness for an application of the patented fibre complex from
Opuntia ficus indica within the framework of meals rich in fat content.

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Confidential: This document contains information that is the confidential and proprietary property of InQpharm. Neither this document nor the information
therein may be reproduced, used or distributed to or for the benefit of any third party without the prior written consent of InQpharm.
Summary Of Report by the TNO Institute (Netherlands) On Fat Binding Capacity of a
Patented Fibre Complex Of Opuntia Ficus Indica
The TNO-report is based on a gastrointestinal model simulating very closely the dynamic
processes in the gastrointestinal tract such as the pH curves and concentrations of pro-enzymes
in the stomach and small intestine, concentration of bile salts in the different parts of the gut,
and the kinetics of passage of chime through the stomach and intestine.
This model was developed to study the digestibility and availability for absorption of nutrients
as well as the stability of specific ingredients. Validation experiments with various types of
food products showed the reproducibility and reliability of the results for the digestibility and
the absorption of nutrients in comparison to in vivo experiments1. Specific absorption systems
have been developed for this model to study the absorption of fat digestion products and fat–
soluble nutrients such as fat-soluble vitamins.
Aim of this study was to determine the fat binding capacity of a patented fibre complex from
Opuntia ficus indica during passage through a dynamic, computer-controlled model of the
stomach and small intestine.
Test products and diet:
Two grams of the test product patented fibre complex of Opuntia ficus indica was added to a
standardised meal. The meal consisted of 20 grams of sunflower oil, homogenised with 144 g of
skimmed yoghurt by gently stirring during 2 minutes. The mixture of patented fibre complex
from Opuntia ficus indica and standardised meal was fed quantitatively to the model.
Results:
The experiments showed that two grams of patented fibre complex from Opuntia ficus indica
prevented the absorption of 2.7 grams of fatty acids during the four hours of experiment in the
gastrointestinal model. Furthermore it was proved that the fat binding to the patented fibre
complex of Opuntia ficus indica is not selective for specific fatty acids, but in regard to the
percentage similar for each individual fatty acid (72 ± 7%).
Conclusion:
Patented fibre complex of Opuntia ficus indica is able to bind to fat and thus prevent the
absorption of approximately 28.3% in the gastrointestinal tract. Since the described model
simulates very closely the dynamic digestive processes, it can be expected that the product
will reach similar results in vivo as shown in the in vitro experiments.
1 Minekus, M., Development and validation of a dynamic model of the gastrointestinal tract. PhD Thesis, University of
Utrecht; Elinkwyk b.v., Utrecht, NL, (1998).

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Confidential: This document contains information that is the confidential and proprietary property of InQpharm. Neither this document nor the information
therein may be reproduced, used or distributed to or for the benefit of any third party without the prior written consent of InQpharm.
Summary Of TNO Report On Fat Binding Capacity Of a Patented Fibre Complex Of
Opuntia Ficus Indica In Presence Of An American Breakfast
The TNO in-vitro gastrointestinal models simulate in high degree the successive dynamic
processes in the stomach, the small intestine (TIM-1) (Minekus et al., 1995; Havenaar and
Minekus, 1996; 1998) and the large intestine (TIM-2) (Minekus et al., 1999, Venema et al.,
2000). These systems are unique tools to study the stability, release, absorption and
bioconversion of nutrients, chemicals and pharmaceuticals in the gastrointestinal tract.
The aim of the study was to determine the fat binding behaviour of the patented fibre complex
of Opuntia ficus indica, added to an American breakfast, during passage through the gastric
and small intestinal model.
Methods:
The experiments were performed under the average conditions of the gastrointestinal tract as
described for healthy young adults after the intake of a breakfast. The set-points in the
computer protocol dictated the transport of the meal, secretion rates and pH values for each
compartment in time.
A specific absorption system is used to remove products of lipid digestion and lipophilic
compounds that are incorporated in mixed micelles. The removed material was collected to
determine the bio accessible fraction. The tests were performed in duplicate, for 4 hours.
The efficacy of patented fibre complex of Opuntia ficus indica to bind fat was tested by
measuring the bio-accessible lipid fraction at the dosage of 2g of patented fibre complex of
Opuntia ficus indica preliminary mixed with sunflower oil (3g), and added to an American
breakfast.
Conclusion:
The results confirm properties patented fibre complex of Opuntia ficus indica, so confirming
previous results obtained with the same TNO model. Actually, associated with an American
breakfast intake, the patented fibre complex of Opuntia ficus indica
absorbs about 23% of total
fatty acids compared to a control. This study is particularly interesting because the fat binding
capacity of patented fibre complex of Opuntia ficus indica
is confirmed when the fibre complex
is added to a complex food formula, the FDA American breakfast.

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Confidential: This document contains information that is the confidential and proprietary property of InQpharm. Neither this document nor the information
therein may be reproduced, used or distributed to or for the benefit of any third party without the prior written consent of InQpharm.
Complementary Results: Effects Of Patented Fibre Complex Of Opuntia Ficus Indica
On The Binding Of Non-Specific Fat-Soluble Vitamins, Bile Salts And Acids
In addition to the fat absorption properties of a patented fibre complex of Opuntia ficus indica,
the effect on the fat-soluble vitamins A and E as well as on bile salts and acid were examined
in vitro and in a clinical pre-study.
Vitamins A and E:
The fat binding product patented fibre complex of Opuntia ficus indica was added to a mixture
of sunflower oil containing approximately the recommended daily nutritional amount of
vitamins A and E. The test was performed under conditions (aqueous phase, temperature, pH)
comparable with those of the digestive tract. Patented fibre complex of Opuntia ficus indica
interacts with the fat content and decreases the quantity of fat remaining in the medium. By
analysing the vitamins in each remaining fatty phase the capacity of patented fibre complex of
Opuntia ficus indica to bind specifically to fat-soluble vitamins can be evaluated. The results of
the in vitro tests show that patented fibre complex of Opuntia ficus indica does not bind to
fat-soluble vitamins A and E in a specific manner. This is supported by a clinical pre-study. In
conclusion, the product does not pose a risk to vitamin levels.
Bile salts and acids:
The effect of fibre, compared to fat, is its ability to initially interact and, if required, bind to
bile salts. Bile salts are necessary to emulsify the nutritional fat so that it can be transformed
into fatty acids by the pancreatic lipase. Bile salts have also an accelerating effect on the
transit time. Bile acids, cholic acid and its derivatives are derived from cholesterol. In the bile,
they are combined with taurine or glycine to increase their hydrophile and emulsifying
capacity. Colon bacteria separate the cholic acid and its combined amino acid, It is through
this process that bile acids come to be found in the stool. The majority of bile salts are
reabsorbed at the end of the small intestines and returned to the liver by blood circulation
before they are re-excreted. The pool of bile salts is small (2 to 4 g) but the entheropatic cycle
allows for a flow of 12 to 40 g/24 hours in the intestines.
The concentration of the bile acids is measured on freeze-drying stool samples. The results
show that the patented fibre complex from Opuntia ficus indica collects some of the bile acids
and makes them unavailable for digestion of lipids by pancreatic lipase.

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