The American College of Physicians conducted a clinical trial to study the effects of 7-KETO on body fat. Thirty overweight adults were recruited. Half were given 100 mg of 7-KETO twice daily, the other half a placebo. All subjects did aerobic exercises three times per week for 60 minutes. Body composition was tested at the start of the trial and twice more at the 4- and 8-week marks. The 7-KETO group showed a 1.8% reduction in body fat while the control group lost 0.57% body fat. No side effects were reported. Researchers concluded that 7-KETO may reduce body fat at a dosage of 200 mg per person per day.
DHEA is the most plentiful hormone in the human body, but its production declines with age. As the levels of DHEA decrease, so does this important metabolite, 7-KETO. 7-KETO is a powerful antioxidant that aids fat metabolism and supports the production of lean muscle tissue.
During the aging process, the levels of certain hormones participating in the metabolic process decline. For example, the level of the female hormone estrogen, made by the ovarian glands, is dramatically reduced after menopause. The level of melatonin, a hormone made at the pineal gland, also declines steadily after the age of 40. The levels of dehyroepiandrosterone (DHEA) and its numerous derivatives, manufactured in the adrenal glands, begin to decline after the age of 30 with about a 50% decline by the age of 40 and about 85% decline by the age of 70. On the contrary, the levels for cortisol and aldosterone, steroid hormones also manufactured in the adrenal glands, essentially remain constant throughout the entire lifespan or, in cases of excessive stress and anxiety, increase.
Concurrent with the decline of these hormone levels during the aging process, there occurs a series of detrimental physiological and anatomical effects. These include a substantial reduction in protein biosynthesis leading to a net loss in muscle mass, and reduction in bone tissue regeneration leading to a net loss of bone mass (a serious risk factor for the onset of osteoporosis). Other negative effects include the substantial decline in the basal metabolic rate leading to a net increase in fat tissue accumulation, the decline in many immune system functions, and the increased rate of neurodegeneration leading to memory loss.
Given these observations, many reputable scientists attest to a definitive relationship between the age-associated decline in hormones, such as DHEA, and physiologic and anatomic trends observed during the aging process. These same scientists also affirm that the restoration of the levels of these declining hormones could potentially delay the rate of muscle and bone tissue loss, strengthen the immune system, increase the capacity to burn fat, and increase the expression of neuroprotective properties. However, the ingestion of hormones as dietary supplements must reliably demonstrate safety and efficasy in order to eliminate short term and long term side effects.
DHEA is actually an intermediate in the biosynthesis of testosterone and estrogen taking place in the adrenal glands. In addition to this, DHEA exhibits a range of physiological effects that are not related to sex hormones. In in vivo clinical trials on genetically obese and normal animals, DHEA demonstrated anti-obesity (fat reducing) properties. Other controlled experiments in animals resulted in DHEA reducing serum cholesterol, strengthening the immune system and improving memory functions through the improvement of neuroprotective properties.
In order, however, to provide a definitive structure-function claim or a mechanistic rationale as to how these liver mediated metabolic improvements take place, a receptor (either bound to a membrane or existing on an enzyme) for DHEA must be identified. The nature of the receptor would then allow for an explanation as to how these biochemical effects take place. To date, no such DHEA receptor has been found. Therefore, it may be that some metabolite or derivative of DHEA may be responsible for the aforementioned positive physiologic effects. In addition, numerous controlled experiments in both animal and human subjects have demonstrated that the ingestion of DHEA has resulted in the net increase of the sex hormones testosterone and estrogen. Elevated levels of these sex hormones pose an increased risk for a range of undesirable effects.
Based on the seminal work of Professor Henry Lardy, a Villas Professor Emeritus of the University of Wisconsin at Madison, Department of Biochemistry, over 150 derivatives of DHEA were prepared and assayed for safety and efficasy over a period of 10 years. One of the prerequisite criteria in selecting these derivatives for further testing was for them not to convert to any of the sex hormones, such as testosterone and estrogen. Eventually, these carefully executed studies led to the identification of the DHEA analog named 3-acetyl-7-oxo-dehydroepiandrosterone (trademarked 7-KETO™), which exhibited the highest biochemical efficacy with no measurable toxicological side effects.
One of the effects from the ingestion of 7-KETO™ in a double blind, placebo controlled clinical study in humans was the stimulation of liver thermogenic enzymes, which increase heat production using fat as the primary source of energy. Naturally, this resulted to the reduction of adipose fat tissue when combined with systematic exercise. Analogously executed clinical studies in humans resulted in 7-KETO™ improving immunologic profiles (the various attributes characterizing a healthy immune system) and improving memory-related functions. In all cases, 7-KETO™ was demonstrated to be substantially more efficacious than DHEA without the unwanted, sex hormone related, side effects.
The safety evaluation of 7-KETO™ was based on observations from an extensive array of pre-clinical and clinical safety studies in both humans and animal subjects. In all cases, 7-KETO™ was consistently found to be safe for human consumption as a dietary supplement.