FREQUENTLY ASKED QUESTIONS What is 7-Keto®? 7-Keto is a natural substance produced by the body in our adrenal glands. Scientists and physicians believe 7-Keto plays an important role in up-regulating key thermogenic enzymes in the body, thereby enhancing resting metabolic rate. It has extensive clinical evidence supporting its ability to aid in weight loss. Other evidence points to the positive effects that 7-Keto may have on immune and brain function Is 7-Keto related to the hormone DHEA? What is the difference between 7-Keto and DHEA? 7-Keto is a natural metabolite that is produced in the body from DHEA. Research scientists at the University of Wisconsin isolated the 7-oxo metabolite of DHEA and developed a method to produce it. Like DHEA, the levels of 7-Keto decline with age. 7-Keto is chemically distinct from DHEA and they are two completely different chemical entities. After 7-Keto is derived from DHEA, it cannot convert back to DHEA in the body. The chief difference between 7-Keto and DHEA is that 7-Keto cannot convert to other steroid hormones in the body. Is 7-Keto a hormone? No, 7-Keto is not a hormone. Hormones are chemical substances produced by the body that have a specific regulatory effect on the activity of a certain organ; usually through the interaction of the hormone with a specific receptor. Our research reveals that 7-Keto has no known receptor in the human body and no specific regulatory function. Why do I need to take 7-Keto if my body makes it naturally? As we age our natural production of this metabolite declines. This decline is most dramatic after the age of 30. By age 40, we produce only half as much 7-Keto as we did at age 20. This decline continues throughout the rest of our lives. Where does 7-Keto come from? 7-Keto is made from plant sources. It is manufactured to a very high level of purity to look exactly like the 7-Keto your body produces. Is 7-Keto natural? We call 7-Keto “the most natural” of natural products. This is because it is naturally found in everyone’s body. By taking 7-Keto, you are simply putting back something that declines as we age. How long has 7-Keto been around? 7-Keto was initially discovered in the human body in the 1950’s, however, its usefulness in weight loss was not discovered until the 1990’s by researchers at the University of Wisconsin. Does 7-Keto have any side effects?Is 7-Keto safe? 7-Keto does not have any known side effects. It has been put through very rigorous testing to insure that it is safe. The safety testing was presented to the Food and Drug Administration for their review before this product was offered to the public. In our clinical studies there have been no reports of serious adverse events and since being on the market in 1998, there have been no reports of serious adverse events by consumers. However, everyone is unique and certain individuals react differently to the same substance. Does 7-Keto have any benefits beside weight loss? Researchers have studied 7-Keto for other benefits including helping improve the immune system and improving memory. What age do you have to be to take 7-Keto? 7-Keto has only been tested in adults and probably only has a beneficial effect as a supplement in individuals older than age 25, when the natural decline in 7-Keto begins to occur. Can 7-Keto and DHEA be taken together? Yes, both can be safely taken together but the combination is unnecessary unless hormonal effects of DHEA are desired. Any individual taking DHEA should consult with their physician. Will 7-Keto affect my blood pressure? In three clinical trials, 7-Keto has never shown any adverse effects on blood pressure. In one trial, blood pressure actually had a slight decline. Does 7-Keto affect risks of cancer? No Have there been any controlled clinical trials using 7-Keto for weight loss? Yes. There are two clinical trials using 7-Keto for weight loss at a dose of 200 mg per day. Both of these studies have been published in peer-reviewed scientific journals. Each of these studies were double blind and placebo controlled and performed in population of overweight men and women over a period of 8 weeks. The results of each study confirm that administration of 7-Keto at a dose of 100 mg twice daily when combined with a program of diet and exercise will result in a three-fold increase in weight loss and fat loss compared to placebo. There have been three other placebo-controlled studies investigating the effectiveness of 7-Keto in weight management. Two of these studies evaluated 7-Keto in a formulation that included other active ingredients. The third study confirmed the ability of 7-Keto in increase metabolism - even when dieting. Is 7-Keto derived from animal sources? No, it is made from plant sources. It is manufactured to a very high level of purity to look exactly like the 7-Keto your body produces. It would be suitable for both vegetarians and vegans. How does 7-Keto work to enhance weight loss? 7-Keto works naturally with your body to enhance the activity of three key fat burning (thermogenic) enzymes. The up-regulation of these key enzymes provides a higher metabolic rate during periods of calorie restriction and diet modification. 7-Keto works with a program of diet and exercise to accelerate weight and fat loss by 200% over the same period of time compared to comparable dieting and exercise while taking a placebo pill. Are there any drug or supplement interactions with 7-Keto? 7-Keto will not interact adversely with other diet supplements or weight loss aids. 7-Keto will also not interact with common medications for blood pressure control or blood lipid control. 7-Keto has no interaction with Synthroid or other thyroid medications. Since 7-Keto is very structurally similar to DHEA, it may have the ability to inhibit platelet aggregation (similar to Aspirin) and caution should be used if you are taking blood thinners like Coumadin™. You should consult your physician before taking and dietary supplement and before starting any new weight loss programs. How much weight can I expect to lose with 7-Keto? 7-Keto should be used in conjunction with a program of diet and exercise since this is the healthiest way to lose weight. Our clinical studies have been designed to include 7-Keto into a healthy program of diet and exercise and the average weight loss in these studies was 6 pounds in 8 weeks and 80% of the weight lost by these individuals was body fat. Some of the subjects in these clinical trials lost as much as 22 pounds in 8 weeks. Weight loss in the range of 1-2 pounds per week is considered healthy and studies have shown that weight loss greater than this average typically ends in diet failure and regain of weight. Is 7-Keto an anabolic steroid? No. 7-Keto is not an anabolic or an androgenic steroid. Unlike DHEA, it does not convert to testosterone or other anabolic steroids in the body. Also our research has revealed that 7-Keto itself is not able to interact with the androgen receptor in the body, thereby assuring that it has no ability to produce androgenic or anabolic effects in the body. Is 7-Keto a steroid hormone precursor? No. 7-Keto does not convert to any steroids that have any hormone related characteristics. Particularly, 7-Keto does not convert to any androgenic, anabolic or estrogenic hormones. Does 7-Keto contain any stimulants like ephedra? No. 7-Keto is a very purified single molecular compound that itself has no cardiac or central nervous system stimulating characteristics. There is not ephedra or ephedrine in 7-Keto. In our clinical studies, no adverse events related to stimulating side effects were reported. Also, since being on the market to consumers there have been no reports of stimulating side effects from taking 7-Keto in the past 4 years and with over 180 million doses sold. Will 7-Keto affect my testosterone, estrogen or DHEA levels? No. 7-Keto is chemically distinct from testosterone, estrogen and DHEA and will not affect the blood levels of these steroids hormones. Also, our research has confirmed that 7-Keto does not convert to testosterone, estrogen or DHEA in the body. When is the best time of day to take 7-Keto? 7-Keto is best taken in divided doses two times daily. We usually suggest that the doses be spaced about 8 hours apart. 7-Keto may be taken with or without a meal. Does 7-Keto have any effect on T3, one of the thyroid hormones? No. One clinical study for weight loss showed a slight elevation in T3 (within the normal range) in the subjects taking 7-Keto. Subsequent clinical studies have shown no effect on T3 compared to placebo or compared to baseline values in the subjects taking 7-Keto. Therefore, there is no convincing positive or negative effect on T3 in individuals taking 7-Keto at 200 mg per day. Will 7-Keto affect my appetite/Is 7-Keto an appetite suppressant? 7-Keto acts by a completely different mechanism. 7-Keto is a thermogenic supplement, which means it helps your body convert stored fat to heat energy at a faster rate than if you were just cutting calories. When 7-Keto is part of your dieting plan, severe calorie restriction is not required but rather eating a well balanced healthy diet. In our clinical studies, the subjects taking 7-Keto were eating 1800 calories per day and exercising for one hour three times weekly and they lost three times more weight and body fat than the group taking only a placebo pill. Do I have to change my diet while taking 7-Keto? Most people gain weight because they are eating the wrong kind of food or are eating too much food. If you are like most Americans, you will have to make some minor changes in your diet to allow your body to shift into “fat burning” mode. Calorie restriction is one of the key elements in any weight loss program but this calorie restriction does not have to be painful. We suggest you reduce your calories to 1800 per day, eat 4-5 meals per day and structure your meals so that your daily intake consists of 45% carbohydrates, 35% protein, and 30% fat. Do I have to exercise while taking 7-Keto? Exercise is an important part of any weight loss plan for several reasons; (1) it allows your body to burn more calories, (2) it helps maintain and increase the amount of lean muscle that you have, ultimately increasing your metabolic rate, (3) it helps to tone your muscles so that you look better at your new lower weight, (4) it helps your cardiovascular system circulate more blood and vital nutrients to your muscles and other organs which aids in the fat burning process, and (5) it helps you feel better about your body and yourself and motivates you to continue with your weight loss efforts. The amount of exercise you do is up to you, but the secret is to “get moving”. Even walking three times weekly greatly aids your chances of success. What if I stop taking 7-Keto after I’ve reached my desired weight, will I gain all my weight back? Losing and maintaining your weight is not as easy as taking a pill. There are no magic bullets. 7- Keto helps accelerate your weight loss so that you can achieve your goal weight faster and healthier. The key to maintaining your new lower weight lies in your ability to put the principles of healthy eating and exercise into your daily life. Eating a healthy diet keeps your body in balance and exercising regularly helps to build new metabolically active muscle, which helps you to maintain your new lower weight long-term.
CURRICULUM VITAE NAME John DATE OF BIRTH MARITAL STATUS CHILDREN UNIVERSITY St. George's Hospital Medical School, London, UK AWARDS 1960 Anna Selina Fernee Scholarship: St. George's Hospital Medical School. Medical Research Council Clinical Research Fellow, St. Thomas' Hospital. Wellcome Research Fellowship: MRC Tropical Metabolism Research Unit, University of t
Aventis Pharma Inc. v. Apotex Inc. Aventis Pharma Inc., applicant, and Apotex Inc. and the Minister of Health, respondents, and Schering Corporation, respondent/patentee 2005 FC 1283 2005 CF 1283 Mactavish J. Heard: June 23, 24, 27, 28 and 29, 2005. Intellectual property law -- Patents -- Criteria for patentability -- Inventive ingenuity --Infringement actions -- Defences --