Address: 105005 Moscow, Elezavetinski proezd,10
Tel./Fax (095)261-4991; (095)265-4432
«6 November” 2001
Director of Sports Medicine Administration
Centre of Sports Training
In response to your inquiry, we are sending you the results of the clinical tests carried out at the Russian Research Institute of Physical Culture and Sports on new food supplement “Pure Organic”.
The tests have shown that food supplement “Pure Organic enhances the athlets’ /swimmers’/ physical performance in their aerobic and mixed zones of energy supply. “Pure Organic” proved to be more active than any other kindred adaptogenic supplements having the same composition.
Tests on “Pure Organic” benefits results in:
Considering that “Pure Organic” shows no evidence of doping activity, the supplement can be recommended to the athletes-members of the national teams of Russia as an efficient means for recovery.
Director / O.P. Yushkov
The aim of the test is: to evaluate the effectiveness of food supplement «Pure Organic» to be applied in practice of sports medicine .
In accordance with the rules of registration of medicines and dietary supplements in Russia, and the documents submitted by the customer the tested products are specified as specialized doping free food supplements ( but not as pharmacological agents ). The copies of the registration certificates and antidoping certificates are attached.
Research was carried out on the subjects – swimmers from the Olympic Training Center ( CSC ) in Moscow. Find below the characteristics of the subjects .
Two weeks before the start of the experiment all the athletes were examined by health care officers . All the subjects were eligible to participate in a clinical trial ( meeting inclusion criteria – healthy).
Subjects’ choice for sports specialization was defined by the type of their training and event loads.
The length in time of swimming within the indicated distance range from 25 sec. to 5 min., which in principal, corresponds to the mixed energy supplying zone under pressure. This type of sports specialization more likely enables with high propability to extrapolate the results to many types of sporting activities ( as cycliс sports – track and field running, rowing, speed skating, etc., as well as games), in which workout length is proportioned to the length of the chosen kind of loading.
The experiment was conducted within the framework of camp training programm at the Palace of water sports from 8 to 26 October, 2001. After having been medically examined the participants were staying at the training camp for 3 weeks that enabled to maintain virtually the same conditions of loads and recovery mode, the standard dietary nutrition and permanent medical control. The load schedule was set by the so-called microcycle “6 (working days) +1 ( day off-rest)”, distributed by type 3.5 + 2.5 working days.
Sports qualification of the subjects (see above) made it possible to distribute them randomly in the experimental and control groups:
In accordance with the terms of the training session all the subjects at the beginning and end of the experiment ( 1st and 20th days of training camping ) underwent comprehensive testing (evaluation test of general and special performance) and medical examination ( paraclinical and laboratory ) . At the end of the experiment basing on the case reports ( their diaries) the subjects filled the forms of individual self-assessed performance .
The overall performance was evaluated by Cooper test (to run as far as possible within 12- minutes on the track of the stadium ). Special performance was evaluated by the test of incremental loading 8×200 meters ( one-minute interval between each step ) with parallel lactate level measuring.
Medical control included daily monitoring of heart rate and blood pressure with a parallel assessment of the first ( morning ) urine and lactate levels , as well as medical examination of the subjects . At the beginning and end of the experiment caliperometric examination of the subjects was conducted by Matejko (definition of absolute and relative values of muscle and body fat mass and weight) .
To measure hormone level in the subjects at the beginning and end of the experiment there was determined testosterone level and its metabolites (epitestosterone, androstandiola and T/E ratio) in urine by chromato mass spectrometry and cortisol level in the blood.
We used supplement «Pure Organic» and placebo in identical forms and package (production of ” Teva ” LLC , Russia) provided by the customer.
We used dietary supplement “Elton” with similar composition and indications to compare with the testing preparation. Strictly according to the recommendations of the company- manufacturer the use of the products was according to the following scheme:
Experimental group I: administered Pure Organic a tablespoon 30 minutes before meals, three times a day in accordance with the plan of the training period (two training sessions per day). The course duration is 14 days (including days of rest).
Experimental group II: administered Elton 1 tablet intake, 15 minutes, before meals three times per day. The course duration was 14 days (including days of rest).
Control: placebo intake by the athletes in the group was in the same way as in group I.
Statistical data processing was carried out by a standard program.
Anti-doping expertise.* Use of specialised dietary supplement Pure Organic (PO) in practice of sports medicine is officially verified by the relevant certificate of Moscow Antidoping center granted international accreditation.
Therefore, we can draw a conclusion that the combined dietary supplement Pure Organic can be used in sports practice as certified doping free supplement .
* According to the regulations of doping control, accredited by the IOC ,anti-doping test is carried out only for the substances intended for oral intake by any way.
According to the common methods of testing athletes’ overall performance in cyclic disciplines, Cooper test was applied, which allows to assess the overall aerobic performance (L.P.Matveev, 1981). Table 1 shows the Cooper test results for the subjects before and after the course of application of the tested products.
Analysis of the obtained data recorded after the course of PO and Elton were applied for 2 weeks did not show any significant growth in overall performance by Cooper Test. There was some longer distance of the run (respectively 9 and 4 m), covered by the subjects of the experienced groups I and II, which tended to be the evidence of the increased overall performance of the athletes after PO intake and the preparation to be compared and the tendency was more evident in case with Pure Organic.
Cooper test results in different groups of subjects
|Subjects groups||Results of Cooper test (meters per 1 min)|
|Before intake||After intake|
|experimental I||4712+ 9,2||4721+ 14,1|
|experimental II||4694+ 11,0||4698+ 11,4|
|control||4701+ 8,9||4695+ 9,8|
Special performance testing of the subjects in various zones of energy generation was done by the method of incremental loading in swimming 8×200 m with parallel monitoring of the lactic acid level (N.I.Volkov 1986, E.A.Shirkovets 1994). It was found that the 2-week use of PO and Elton caused an evident reduction of the time of swimming at the fixed 200-meter length distance with parallel decrease in lactate level in the peripheral blood to the level of ANSPs.
In other words, after the end of the supplements course there was registered a significant increase in swim pace in the subjects of experimental groups I and II with a fixed lactate (the so-called “lactate curve line shift to the right). Thus, after «Pure Organic» use a similar benefit seemed to be more if compared with Elton.
A similar effect of the increased pace in the control group of athletes who took a placebo, became lost at lactate level above -2 mM. Although any significant differences by criterion of subjects’ running pace growth at a fixed lactate level above ANSP were not registered in the experimental groups, the most obvious beneficial effect of the dietary supplement tended to be in experimental group 1 if compared to the control group (Table. 2).
Subjects‘ pace growth in the incremental test of loading (cm / min)
|Lactate level mM/l||Experimental I||Experimental II||Control|
|2||18,2 + 3,9||11,9 + 3,1||7,1+ 3,8|
|4||14,2 + 2,8||10,7 + 2,7||3,7 + 2,1*|
|6||7,1 +2,4*||5,0 + 2,9*||0,9 + 0,6*|
|8||5,1 + 1,4*||3,9 + 1,2*||0,4 + 0,2|
Thus, the use of dietary supplement Pure Organic beneficially improves the special performance: athletes in aerobic and aerobics developing zones of energy supply, and tends to have the same effect in the mixed zone. Pure Organic benefit significantly exceeds the similar action of Elton.*Statistically non valid (p> 0.05)
Testosterone and its isomer epitestesterone, as well as testosterone metabolite androstandiol were chosen as hormone background indicators, their ratio changes to a certain extent are specific for the athletes doing cyclic sports ( in particular: swimming, field and track and others)
In addition, to evaluate the benefit of the tested dietary supplements a cortisol level test was performed to measure the level of cortisol present in the blood, one of the principle hormones in the energy supply mixed zone.
It is known that permanent cyclic stressors in the range of aerobic to glycolytic loads result in a diphasic change in testosterone level in the body: at first a short rise (first 3-7 days) occurred, and then a steady decline (below baseline) followed up. ( Mainwarring W.T.P., 1981; D.Catlin, 1988).
A clear direct correlation between the testosterone concentration and athletes‘ performance level was proved (V.N.Rogozkin 1985-94).
In fact, after a three-week training session some decline in the testosterone (T) level in the urine of the athletes in the control groups was maintained. On average, this regression was to 5.3% (P <0.05), ie. from 12.34 to 11.62 mg / l. It is characteristic that, decline of epitestosterone (E) and androstenediol (A) levels and T/E ratio was maintained within the range of the basic value. The latter indicated no evidence of administration of other medicines (primarily anabolic steroids) and proved experimental validity.
Unlike the control group, the experimental group I showed a marked beneficial effect of dietary supplement PO on testosterone and its major metabolites in urine (Table. 3).
Testosterone, epitestosterone and androsterone levels in the subjects before and after the course of Pure Organic intake
|Parameters||before intake mg/l||after intake (mg/l|
|testosterone(Т)||8,07+ 0,39||9,26+ 0,27|
|epitestosterone(Е)||5,92+ 0,47||6,90+ 0,32|
|T/E||1,36+ 0,09||1,34+ 0.12*|
|androsterone||976+ 13||1049+ 21|
* difference compared to basic value not valid (Р >0,05)
As seen from Table 3, on average, the increase of testosterone levels in the subjects having taken Pure Organic for 2 weeks, was about12%. And again, as in the two control groups the changes in T / E ratio were not detected which proved that but Pure Organic other preparations ( for example testosterone derivatives) capable to increase testosterone levels were not consumed.
Thus, the course application of Pure
Organic within 3 weeks not only prevents a decline in testosterone levels caused by long
loading times, but also stimulates development of additional amount of sex hormone in the male athletes.
A similar effect was not registered when athletes took Elton and placebo under the same experimental conditions, that is all test indicators of testosterone metabolism did not significantly change during the second testing at the end of the experiment.
Changes in the body composition (absolute and relative muscle and fat mass indices) registered by Caliper metric method within 3 weeks, were characteristic of the applied mode of loads for the athletes of the control group.
In accordance with the training program stage of the subjects, their loads in the experiment period mostly related to ANSP level (anaerobic threshold) and the baseline zone of the mixed metabolism.
Under such schedule moderate muscle mass reduction- by 1.46% (P <0.05) and almost constant fat mass was maintained in athletes of experimental group II and control group by the end of the experiment.
These results agree well with the overall dynamics of body composition in cyclic sports athletes under the loads (TF Abramova, 1989).
Unlike the results in placebo and control groups, Pure Organic use could markedly contribute to consumption of body fat storage resulting in fat mass reduction maintained by the end of the experiment. (Table. 4).
If we take into account the fact that there was no evidence of significant muscle mass reduction when PO -complex was consumed, we could assume that the dietary supplement to a certain degree “triggers” the athletes to consume the energy of fat resources.
There were no significant differences in a body composition of the subjects in the control group and the experimental group II (placebo) were registered.
Thus, It can be concluded that the course consumption of Pure Organic during 2 weeks by swimmers leads to a reduction in fat mass and lean body mass stabilization.
Changes in body composition in swimmers before and after Pure Organic consumption during two weeks.
|Parameters of body composition||before course||after course|
|Body mass kg||61,2 +0,9||60,6 +1,0*|
|Muscle mass kg|
|absolute||30,7 + 0,4||30,3 +0,5*|
|relative||50,1 + 0,4||49,4 + 0,8|
|absolute kg||17,2 + 0,2||7,01 + 0,2|
|relative||11,8 + 0,6||9|
* differences compared to basic value are not valid (Р >0,05)
Medical examination of the subjects (ECG at the beginning and end of the experiment, daily check-in heart rate and blood pressure, the athletes questionnaire) did not reveal any adverse effects of Pure Organic. In two cases, allergic reactions of the skin type were found, but the examination showed that this pathology were related to the consumption of other foods, for which the athletes used to have the similar allergic reaction before.
The self-assessment by the athletes on dietary supplement PO benefit was carried out by a method of special questionnaires. Almost all the subjects from the experimental group I noted a good well-being, wish for training, the high level of the central nervous system tone at the day time, fast sleep ay night and other subjective signs of good health
Summing up the above data – we conclude that course application of the combined dietary supplement «Pure Organic» has a beneficial effect on physical performance in swimmers in the aerobic and mixed zones of energy supply. Taking into account the supplement effect on testosterone levels in the urine , PO can be used as an effective means of athletes recovery after specified loads.
Head of the Department of medico-biological research in sports,