Research Institute of Physical Culture and Sports Russia

Address: 105005 Moscow, Elezavetinski proezd,10
Tel./Fax (095)261-4991; (095)265-4432

№ 185-19/2
«6 November”  2001

TO:
Saninsky  V.N
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:

• increase in performance of the athletes  doing cyclic sports in their first and second zones of energy supply;
• testosterone level gain in the bodies of athletes having heavy loads;
• body mass balance due to reduction of absolute and relative amount in fat mass of the body.

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

2. PURPOSE AND OBJECTIVES OF THE STUDY

The aim of the test is:  to evaluate  the effectiveness of   food supplement «Pure Organic» to be applied in practice of sports medicine .

Research tasks:

1. Evaluation of Pure Organic effect on overall and special  performance of the experienced  athletes .
2. Evaluation of Pure Organic effect on hormonal response of top athletes.
3. Development of practical recommendations on Pure Organic application 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.

3. EXPERIMENTAL GROUP

Research was carried out on the subjects – swimmers  from the Olympic Training Center ( CSC ) in Moscow. Find below the  characteristics of  the subjects .

• The total number of subjects: 12,
• Athletes:12person-(6-male,6- female),
• Specialization : Sport swimming ( Olympic program types 50-400 m  different styles ),
• Qualifications : candidates for masters of sports -2 ;  masters of sports -7; candidates for ms -3 (russian sporting awards scale),
• Age: from 16 to 25 years.

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.

4. STUDIES SCHEME

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:

1. Experimental I (Pure Organic) – 4 athletes
2. Experimental  II ( Elton ) – 4 athletes
3. Control (placebo ) – 4 athletes

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.

5. RESULTS

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.

Efficiency  of «Pure Organic» on parameters of overall and special performance

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.

Table 1

Cooper test results in different groups  of subjects

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).

Table 2

Subjects‘ pace growth in the  incremental test  of loading (cm / min)

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)

Pure Organic benefit on hormone level of the subjects

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).

Table 3

Testosterone, epitestosterone and androsterone  levels in the subjects before and after the course of Pure Organic  intake

* 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.

Pure Organic effect  on body composition of the subjects

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.

Table 4

Changes in body composition in swimmers before and after Pure Organic consumption during two weeks.

* differences compared to basic value are not valid (Р >0,05)

Medical control of the subjects and their health testing

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.

CONCLUSIONS

1. Specially made food supplement “Pure Organic” shows negative doping activity, so it is safe to be used in sports medicine without any restrictions.
2. Food supplement “Pure Organic” is to be recommended as an efficient preparation to enhance performance in the athletes’s aerobic and mixed zones of energy supply at the period of recovery.
3. The recommended course of ” Pure Organic” which lasts for two weeks, results in the rise of testosterone levels and its metabolites in urine, which is the evidence that stabilized sex hormone is generated in the body of athletes under intense physical loads.
4. The complete two week course of “Pure Organic” tends to speed up fat consumption from the depot and thin down fat mass in a hypodermic fat deposit at the period of intensive training.
5. No by-effects or any negative organoleptic characteristics of “Pure Organic” have been registered.

Head of the Department of medico-biological research in sports,

S.N. Portugalov