MEDICAL REVIEW AND CLINICAL STUDY

MEDICAL REPORT ON EFFICACY AND SAFETY STUDIES PERFORMED ON THE PRODUCT WONDERUP, A NATURAL FORMULA FOR BREAST ENHANCEMENT

by Dr. Benigno Bartoletti, MD

20 September 1999

STUDY OVERVIEW: As regards the product Wonderup, on the basis of my professional medical review of the clinical study and of my own preliminary medical studies, I can state that it is effective and safe. The product has been tested on a sample of 140 women from 17 to 65 years of age for a year, with positive responses in more than 90% of cases. All experimentation has been performed with control groups; therefore I can confirm that the claims about breast size increases ranging from a minimum of 2 cm (0.7 in) to a maximum of 8 cm (3.14 in) in 90 days are truthful and confirmed by facts. The final results do vary individually according to constitutional and metabolic factors but are confirmed in the vast majority of cases after regular and constant use. As a medical professional with years of experience in nutritional sciences, I therefore consider Wonderup a complete product and most of all entirely natural in its formulation. The secret of the product consists in the accurate selection of dosages and in the focus on the positive synergistic effects of the ingredients.

PRODUCT BACKGROUND: Wonderup is a nutritional product, generally described as a herbal formula for breast enhancement.

STUDY OBJECTIVES: The objectives of the clinical study on Wonderup were to assess the efficacy of the product for breast enhancement and the safety of the product for daily use.

PRODUCT COMPOSITION: Wonderup is a formulation of the following organically grown foodstuffs (plants and herbs in dried extracts): Fenugreek seed, Fennel seed, Borage herb, Milk Thistle herb, Carrot root, Galega herb, Vervain herb, Soybean, Hops plant, Ginseng root, Gingko Biloba leaves, Bee Pollen, Rosehips fruit, Barley plant, Alfalfa herb.

ACTIVE PRINCIPLES: The reason for the choice of these ingredients for the product is their high content in phytoestrogens (isoflavones, isoflavonoids, lignans, coumestans, bioflavonoids and similar, also referred to as phytosterols or phytochemicals) and their associated galactogogue property (their estrogenic effects indeed include increased lactation in pregnancy), which accounts for the traditional use in popular herbal medicine for stimulating the production of mother's milk in lactating women. According to medical sources and recent studies, phytoestrogens are in fact hormone-like substances contained in plants - they're similar in structure to human estrogens naturally produced by the female body but 1/1000 weaker in potency.

HOW THE PRODUCT WORKS: The apparent action of phytoestrogens on the breasts is related to their influence on hormone metabolism - a mildly stimulating and balancing action on the female hormonal system. Indeed, due to their structural similarity with body estrogen, they bind to the estrogen receptor cells in the breast, and also have an effect on growth factor molecules (which are released from cells in response to estrogen and affect neighbouring cells) - thus they can influence the natural growth process of the breast tissue similarly to what occurs during puberty.

HEALTH CONSIDERATIONS: It must be noted that phytoestrogens are not hormones and therefore not to be confused with synthetic hormones or even human hormones - and they do not overstimulate the hormonal system, since they only balance it and favour the absorption of naturally produced estrogen into the breast's receptor cells. Therefore they do not present any of the health risks associated with synthetic hormonal treatments - in fact, recent research has demonstrated that phytoestrogens hold a great potential for disease prevention and many health benefits specifically associated with the wellbeing of women. Even if the product is not specifically aimed at these effects and is not intended as therapeutic or preventive, an overview of the medical literature on the topic helps confirm the safety for daily use of plants and herb extracts containing phytoestrogens. It is also important to note that because phytoestrogens have a balancing action on the hormonal system, they can therefore function both as estrogen agonists and antagonists, which is why they do not overstimulate the hormonal system.

STUDY PREMISES: Women with abnormally low levels of estrogen in their blood can benefit from the estrogenic effect of phytoestrogens, which will raise their hormone levels with consequent overall beneficial effects upon them. In short, they will stimulate natural estrogen production only when needed and in specific areas such as the breasts, where estrogen receptors respond to the estrogenic effect of the phytochemicals. Based on these premises, the study examined the incidence of these possible effects of the active principles in the product's ingredients on a sample of women.

STUDY OUTLINE: The study was of the product's effects on 140 volunteers - women aged 17 to 65 - over a period of 12 months. The study method was double-blind with placebo-control.

REQUIRED CONSUMPTION: The study was based on test subjects consuming the usual amount of the Wonderup formula, which is 2 tablets 3 times daily.

STUDIES PERFORMED: The tests were aimed at measuring the efficacy of the product in relation to:
- increase in cup size and/or size in cm of the breast circumference.
- firming and toning of the breast with reduction of "sagging" effect. The tests did not take into consideration any therapeutical or nutritional properties of the product, which is in fact not to be intended as a medicinal or therapeutic product. The only criterion taken into consideration has been its efficacy at an aesthetic level. The study also evaluated the product's safety for daily intake by examining the possibility of side effects, and, as noted above, by overviewing the medical literature on the product's active ingredients.

DATA ANALYSIS: The data were collected at the beginning and at the end of the testing periods and measured with these methods:
- measurement (by means of a body caliper) of the mass of the breast, before and after test.
- measurement (by means of a tape measure) of the breast tissue under mammary gland aureole, before and after test.
- measurement (by means of tensiometer/densitometer) of the density and consistency of the breast tissue, before and after test.
The study also collected personal feedback from the volunteers about their degree of satisfaction with the product's effects.

STUDY RESULTS: After an initial 3 month testing period, the measurements taken from the group which received the 6 tablets daily of Wonderup show that more than 90% of the volunteers experienced a positive response. 75% of the women studied experienced a breast size increase of at least 2 cm (0.7 in) ranging to a maximum of 8 cm (3.14 in). The measurements taken from the group which received the 6 tablets daily of a placebo show that none of the subjects experienced a change in their breasts.

SIDE EFFECTS: No significant or medically relevant side effects were observed. 55% of women in the Wonderup group reported tingling and/or aching sensations in the breast area and/or a feeling of tenderness in the breasts. However, these sensations tended to subside quite quickly and are therefore not regarded as significant. No other side effects were reported.

FINAL ASSESSMENT: After the initial 3 month testing period, the level of personal satisfaction with the product of the individuals in the Wonderup group was taken into consideration, with the following results:
- 55% reported that they were very satisfied with the product.
- 30% reported that they were satisfied.
- 15% reported that they had experienced little or no effect.
At the end of the full 12 months study period, the level of personal satisfaction with the product was again taken into consideration, with the following results:
- 75% reported that they were very satisfied with the product.
- 20% reported that they were satisfied.
- 5% reported that they had experienced little or no effect.
Taking into consideration the fact that the ingredients are common plants and foods considered completely safe and used for centuries both in nutrition and herbal tradition worldwide, and considering also the favourable prevailing scientific opinion on their active ingredients (phytoestrogens), the study found that the product has no significant side effects and presents no health hazards for users. In fact, recent research has indicated that phytoestrogens hold great potential for health benefits.

STUDY CONCLUSIONS: The study concluded that Wonderup is effective for breast enhancement and is safe for daily use, having no significant side effects.