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.
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).
Efficiency of patented fibre complex from Opuntia ficus indica on blood lipids
parameters considered as risk factors for Metabolic Syndrome (Syndrome X)
Purpose:
The clinical study was aimed at evaluating the efficiency of a patented fibre complex from
Opuntia ficus indica on blood lipid parameters. The patented complex has a fibre content that
is on average eleven times higher than generic extracts from the same plant.
Sixty-eight females with Metabolic Syndrome (Syndrome X) and a BMI (Body Mass Index)
between 25 and 40 participated in this mono-centric randomised, placebo-controlled, parallel
double-blind study.
Methods:
During 6 weeks, half of the females consumed 1.6g of the patented fibre complex from Opuntia
ficus indica per meal and the other half consumed a placebo. The entire group followed a wellbalanced
diet with a controlled lipid input. The placebo and patented fibre complex from
Opuntia ficus indica were given in the form of capsules.
The efficiency of the tested product was evaluated, on day 14 and on day 42 of the study.
Several lipid parameters were measured: changes in LDL cholesterol, HDL cholesterol, serum
triglycerides, and at the end of the study, the participants were re-evaluated for metabolic
syndrome.
Results:
On and after the 14th day of the study, patented fibre complex from Opuntia ficus indica
showed a decrease in LDL cholesterol levels by 10%, compared to a 3% decrease in the placebo
group. The HDL cholesterol levels in the group, which consumed patented fibre complex from
Opuntia ficus indica, showed an upward significant trend throughout the course of the study,
where else the placebo group showed a downward trend. Overall, patented fibre complex from
Opuntia ficus indica showed a beneficial effect on good cholesterol, which is generally
associated with a reduced cardiovascular risk.
During the first 14 days of the study, the number of volunteers with Metabolic Syndrome
decreases in both groups. However, after 42 days of treatment, 39% of the volunteers from the
patented fibre complex from Opuntia ficus indica group were diagnosed to be free from
Metabolic Syndrome, in comparison to 8% in the placebo group.
On a receptive population, near than 60% of women who consumed patented fibre complex
from Opuntia ficus indica were diagnosed to be free of Metabolic Syndrome.
No particular side effects were observed when taking patented fibre complex from Opuntia
ficus indica.
Conclusion:
These results suggest that the patented fibre complex from Opuntia ficus indica could regulate
blood lipid levels and thus participate in reducing cardiovascular risk. Therefore, the patented
fibre complex from Opuntia ficus indica is efficient in applications related to cardiovascular
risks prevention, when associated with overweight problems.
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