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Juvenon has an ongoing program of pre-clinical and clinical research to learn more about the aging process and how to mitigate its effects. Recently completed and in-process studies are described here.
A clinical trial has recently been completed at the Whitaker Cardiovascular Institute, a unit of the Boston University Medical Center. The objective of the trial is to evaluate the effect of Juvenon™ Cellular Health Supplement on cardiovascular patients. This is a double-blind, randomized, placebo-controlled crossover study, involving older individuals (55 to 95 years old) with proven coronary artery disease.
The study involved a total of 43 patients. Each one underwent an 8-week treatment with either the Juvenon™ Cellular Health Supplement tablet or a placebo, followed by a 4-week "washout" period, and then by a second 8-week period with the alternative treatment. All subjects have completed the course of treatment. Researchers are currently analyzing the data. Results have not yet been released. The researchers have indicated that the next steps are to complete and interpret statistical analyses, write up the findings and conclusions, submit the findings to peer review, and finally to publish the results. A forum for publication of the results (i.e., a peer-reviewed journal or scientific meeting) has not yet been determined.
Before bringing Juvenon™ Cellular Health Supplement to market, Juvenon conducted a clinical trial designed to assess the effects of the product on indicators (biomarkers) of exercise-induced oxidative stress, muscle strength/endurance, body composition, functional fitness, physical activity, and general health and well being in healthy sedentary older men.
Energy Study Design - This was a single-center, randomized, double-blind, placebo-controlled study lasting 17 weeks. A two-sequence, crossover design was used for this study. Subjects were 18 healthy, sedentary men between the ages of 60 and 71. They received either a tablet containing Juvenon™ Cellular Health Supplement or a placebo tablet in the first treatment period. This was followed by a "washout" period during which they took neither Juvenon™ Cellular Health Supplement nor placebo. Then, during the second treatment period, they received the alternate study agent. This crossover design facilitates understanding of treatment effect vs. placebo effect by controlling intra-subject variation.
The trial was conducted in an exercise physiology laboratory operated under the auspices of the Department of Kinesiology at San Francisco State University. Subjects were asked to perform a sequence of exercises designed to produce oxidative stress. Blood was then drawn and analyzed for biomarkers of oxidative stress.
Subjects also completed a validated psychological survey called the Psychological General Well-Being Index (PGWBI), which was originally developed by the RAND Corporation to assess the physical and mental health of healthy individuals. The PGWBI was administered to evaluate the mental outlook of the subjects when they were taking Juvenon™ Cellular Health Supplement, compared to when they were on placebo.
Energy Study Results - Exercise-induced oxidative stress is a measure of how efficiently and cleanly the mitochondria produce energy. The extent to which cells are stressed following exercise is an indication of cellular health. This is a measure of the body's defenses against the effects of aging. The study evaluated 9 different biomarkers for cellular health and oxidative stress: ammonia, beta-carotene, glutamine, glutathione, malondialdehyde, total antioxidant status (TAS), vitamin C, vitamin E-alpha tocopherol, and vitamin E-gamma tocopherol.
For 8 of the 9 biomarkers, a majority of subjects registered positive results when they were taking the Juvenon product, compared to when they took the placebo. The results for one biomarker, alpha tocopherol, were equivocal.
The scientists concluded that supplementation with Juvenon™ Cellular Health Supplement in the majority of healthy elderly subjects both raised the antioxidant capacity of the plasma and blunted exercise-induced oxidative stress.
The most compelling results of the study were those from the Psychological General Well Being Index (PGWBI). The objective of this portion of the study was to assess subjective perceptions related to mood and general health. The PGWB provides a total score, as well as scores on individual components of health and well being. The "Total Scores" of a majority of subjects were higher when taking Juvenon™ Cellular Health Supplement than when they were on placebo. A majority also reported improved vitality and general health.
Overall, the Energy Study points to evidence of improved cellular health, as indicated by the biomarkers of oxidative stress, and a sense of feeling healthier, as identified in the Psychological General Well Being Index. Note, however, that this was a pilot study with sample sizes too small for statistical significance. Findings were posted at a conference of the American College of Sports Medicine.
Diabetic Rats Study
Juvenon is currently sponsoring a study of the effects of dietary supplementation with lipoic acid and acetyl-L-carnitine on Type 2 diabetic rats. The study is under way at the Linus Pauling Institute at Oregon State University. The study is investigating whether lipoic acid and acetyl L-carnitine act to stimulate glucose and fatty acid metabolism and whether this could reverse the severity of pathophysiological markers of Type 2 diabetes. The experimental model is the obese Zucker rat., which is a well-accepted animal model of Type 2 diabetes because it mimics many of the symptoms associated with this disease.
Juvenon, as well as individual members of the Scientific Advisory Board, have received hundreds of emails in which individuals report their individual experiences with Juvenon™ Cellular Health Supplement. These messages describe a wide variety of undocumented positive effects, negative side effects, alternative approaches to dosing, possible relief from various conditions, and the like. Juvenon is constructing a searchable database that will allow scientists to search these anecdotal reports for possible patterns that could provide insights that could guide future research. Individuals who wish to contribute their observations to the anecdotal database are invited to send their comments to email@example.com.
Cognition in Animals
Juvenon is supporting a collaboration between Dr. Bruce Ames and Lucy Jacobs, a Professor at the University of California. Berkeley. Dr. Jacobs has an automated machine that tests mice for cognition in a more accurate, simpler, and faster way than conventional methods, such that the machine can be used for making improvements in the Juvenon formula.
Human Cells in Culture
The Ames Lab is conducting ongoing testing in several different human cell lines to determine the effects when cells are challenged by oxidative stress, and lipoic acid and acetyl L-carnitine are added. The objective is to determine whether these micronutrients will prevent the toxicity associated with oxidative stress. Results to date indicate that the mixture of the two substances is much more effective than either one alone.
Attitudes on Aging
Juvenon commissioned a nationwide study in 2004 to identify attitudes of Americans toward aging. Juvenon was particularly interested in the following questions:
To view the results of the survey, click here.
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