PRODUCT DESCRIPTION. TESTOFEN TM ( Trigonella foenum graecum) INDICATIONS COMPOSITION CLINICAL TRIALS DESCRIPTION. Effect on muscular tone

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1 Rev.: 27/1/211 PRODUCT DESCRIPTION TESTOFEN TM ( Trigonella foenum graecum) INDICATIONS Testofen TM is a product containing a Fenugreek extract and it is recommended to: - Increase the muscle mass associated with the physical exercise. - Increase the sport performance - Increase the muscular strength - Increase the libido - Increase the performance COMPOSITION Testofen TM is obtained from the Fenugreek seeds (Trigonella foenum-graecum) through a special extractive process which allows extracting Fenugreek active ingredients in a specific proportion existing under the registred trademark of Fenuside TM. The extract is standardized with a Fenuside TM content of more than %. DESCRIPTION Fenugreek is a food rich in nutrients and its seeds are used to elaborate different types of bread. The seeds are used in the Asian countries in a way similar to the cereals ones. Fenugreek seeds contain different active ingredients among which the steroidal saponins stand out such as diosgenin, sapogenins, trimethylamine, several vitamins and essential oil. Fenugreek has been traditionally used to treat the asthenia, the hyperlipidemia and the hyperglycemia. These studies have demonstrated the effectiveness and the safety in its consumption. The experimental animal tests showed that Fenugreek consumption increases testosterone levels with an effect on the body composition: increase in the muscle mass and in the performance, reduction of the visceral fat with an effect on the behaviour, increasing the libido and the frequency of the activity. Fenuside TM active is responsible for the action of Testofen TM on the muscular development as well as on the behaviour. CLINICAL TRIALS Testofen TM efficacy has been evaluated on experimental animals and human subjects according to the clinical results obtained on volunteers who have participated in these studies. Effect on muscular tone Experimental protocol A study on 6 volunteers divided into a control (Testofen TM ) and placebo group has been carried out on people aged between 18 and 3 years which have been subjected to a resistance exercise. The objective of the study was to evaluate Testofen TM efficacy and safety on people who did regular exercise in order to observe its effect on the testosterone concentration and on the muscle composition of the body. Volunteers have taken one capsule of placebo or Testofen TM (3 mg), twice a day during 8-week period, checking several biochemical and anthropometrical parameters.

2 Rev.: 27/1/211 Results At the end of eight weeks of study, no changes in the body mass index (BMI) have been observed in both groups. However, the study showed that volunteers consuming Testofen TM enhanced the following parameters: 1. Level of free testosterone in the blood. Grosor (mm) Grosor del pliegue cutáneo en el grupotestofen TM Antes Después Testosterone increase in the Testofen TM group has been of 1% going from an initial value of pg/ml of testosterone to 3.29 pg/ml (Figure 1), whereas no changes have occurred in the placebo group. Nivel de testosterona en el grupo TESTOFEN TM 2 Triceps Muslo Figure 2. Change in the thickness of the triceps skin fold and the muscle in the control group (Testofen TM ) at the beginning and at the end of the study. 4 pg/ml Antes Después Figure 1. Change in free testosterone s concentration in the blood of control group (Testofen TM ) at the beginning and at the end of the study. 3. Urea concentration in the blood. All people who have taken part in the study have been subjected to a control of urea concentration in the blood at the beginning of the study. 8 weeks after consuming Testofen TM the control group showed a remarkable reduction of the urea (28.28 mg/dl to 2.62 mg/dl), which led to a reduction in the protein catabolism with an increase in the muscle mass during the study. Conclusions 2. Body composition Triceps skin fold thickness has been calculated before and after Testofen TM consumption. The control group showed a remarkable reduction in the triceps skin fold on the indicated parts. Although, this reduction in the skin fold thickness did not lead to a decrease of body weight; this meant that the reduction has been produced by reducing the skin fat with an increase in the muscle mass (Figure 2). The placebo group did not show any differences in this parameter. According to the clinical results obtained with this study, the daily consumption of 6 mg of Testofen TM during 8-week period accompanied with a physical activity had a favourable impact on the increase in testosterone levels. The safety blood parameters that have been controlled did not produce any differences in both groups showing that Testofen TM treatment has been safe in the volunteers that have consumed it.

3 Rev.: 27/1/211 Effect on the behaviour The second clinical study with Testofen TM ended in 29 and aimed at evaluating the effects on the function, the libido and the satisfaction levels in adult males starting from a preparation containing Testofen TM, magnesium, zinc and vitamin B6. Experimental protocol A double-blind randomized clinical trial controlled in comparison with the placebo in Queensland, Australia has been studied for 6 hetero males aged between 21 and years without any dysfunction but that were interested in increasing their libido. Participants have been divided into two groups: a control group (Testofen TM ) and placebo, for a period of 6 weeks. The experimental group received a capsule containing 3 mg of Testofen TM, 4.94 mg of Función, grado de realización y satisfacción Control * p<,1 Placebo Semana 3 Figure 3. Scoring scale changes occurred in the function, realization and satisfaction in the two groups of the study. Figures 4 and show the difference in the scoring between the two groups in each evaluated area. piridoxine, 1 mg of Zn and mg of magnesium, 2 times a day. During the trial biochemical parameters have been evaluated at the beginning of the study, in the third and sixth week. In order to evaluate Testofen TM efficacy on the function a valid questionnaire with 21 questions has been made in relation to four main areas: perception, awakening, behaviour and orgasm. The highest score of the questionnaire is 144 points Categorías de la Escala de Evaluación de la fuinción GRUPO CONTROL Results After 6 weeks of treatment, volunteers of the Testofen TM group showed a remarkable increase in the initial score from 67 to 82 points, whereas the placebo group did not show any remarkable changes (Figure 3). Percepción Despertar Comportamiento Orgasmo Figure 4. Scoring scale changes occurred in each area or category of the study on the function in the control group.

4 Rev.: 27/1/211 Categorías de la Escala de Evaluación de la fuinción GRUPO PLACEBO Erección completa matutina * p<,1 Semana Nº veces / semana Percepción Despertar Comportamiento Orgasmo Control Placebo Figure. Scoring scale changes occurred in each area or category of the function test in the placebo group. 1. Sexual perception/fantasy The control group showed an increase in this parameter scoring which has occurred already after three weeks from the beginning and which remains steady up to the end of the study (21.78 to 2.36, p=.2). The placebo group did not show any remarkable changes. Figure. 6. Complete morning erection during the study carried out on the two groups 4. Orgasm This area evaluated the satisfaction level, the intensity and duration of the orgasm. In the three situations the control group showed an improvement after the product intake whereas the placebo group did not show any changes. 2. Sexual awakening As well as in the previous area, the control group showed a remarkable increase in the scoring at the end of the study whereas any changes have occurred in the placebo group. A significant result was given by the effect on the morning erection which went from 2 to 3 times a week to to 6 in the control group whereas the placebo group did not show any changes. (Image 6) 3. Sexual behaviour Results on the behaviour showed a positive change in the control group compared to the placebo one. As for the frequency in relationships, participants of the control group increased the average frequency from 1-2 times to 3 times a week. No changes have occurred in the placebo group. In addition to these main parameters, Testofen TM effect has been evaluated on other parameters related to the volunteer s health: libido, muscle mass and strength, energy, histamine concentration and sleep using an evaluation scale with a maximum scoring equal to 1. The control group showed significant results whereas the placebo one did not show any changes. All the parameters, except the sleep ones, registered an increase after 6 weeks of study (Table 1).

5 Rev.: 27/1/211 Table 1. Testofen TM effect on the libido, the resistance, muscle mass and muscle strength, energy, histamine and sleep in the control and placebo groups at the beginning and at the end of the study. * p<.1 Parameter Control Placebo Libido Beginning 4.9. Week 6 7.4*.2 Resistance Beginning Week 6 7.3*.9 Muscle mass Beginning Week 6 6.9* 6.1 Muscle strength Beginning Week 6 7.1* 6.2 Energy Beginning Week 6 7.* 6. Histamine Beginning Week 6 7.3* 6. Sleep Beginning Week Conclusions According to the clinical results obtained with this study, the consumption of a product containing Testofen TM, vitamins and minerals with a daily intake of 6 mg of Testofen TM during 6 weeks, produces a positive effect on function, on development and satisfaction level improving specific areas such as activity and awakeness, frequency of the relationships, body muscular development, physical strength, energy and well-being in general. With this study Testofen TM did not produce any increase in testosterone levels nor in any other hormones but we should consider that persons who were subjected to the test were sedentary and didn t do any physical exercise. MECHANISM OF ACTION Two possible mechanisms of action for Testofen TM have been submitted. On one hand Testofen TM could have an action on Hypothalamic-Pituitary-Adrenal Axis with stimulation on hypothalamus to secrete the corticotropin-releasing hormones whose final result would be the release of androgenic hormones from the adrenal cortex, the testosterone s producers. The quantity of testosterone produced by the adrenal stimulation is lower than the one produced in the testicles but its physiological function is more important. Testosterone is involved in the male muscular development, in its characteristics and its behaviour, spermatogenesis, etc. On the other hand, Testofen TM seems to have properties for its own that is the steroid structure of its active ingredients could join the testosterone receptors exercising an action similar to the testosterone typical of the person. SAFETY In the two clinical trials carried out on volunteers, an increase of testosterone has been noticed only in the males group which has practiced a regular sporting activity whereas the males carrying out a sedentary activity, where an increase in the libido has been noticed, the testosterone levels were the same as the control group ones. Neither of the two studies side effects or problems related to testosterone levels has occurred, giving proof of Testofen TM product safety. RECOMMENDED DOSES We recommend 6 mg of Testofen TM per day, to be taken in two times (2 x 3mg) before the main meals.