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Clinically validated data is a valuable asset to pharmaceutical organization. Data from the clinical trials are vital to the whole clinical development procedure. Value of any drug cannot be properly noticed until the clinical data is systematically organised, simply accessible and cleaned.

I bumped into a fascinating paper today by Dr. Loren Cordain titled "Plant-Animal Subsistence Ratios and Macronutrient Estimations in Worldwide Hunter-Gatherer Diets." Published in 2000 in the American Journal of Clinical Nutrition, the paper estimates the food sources and macronutrient intakes of historical hunter-gatherers based on data from 229 different groups. Based on the available data, these groups did not suffer from the diseases of civilization. This is typical of hunter-gatherers. Initial data came from the massive Ethnographic Atlas by Dr. George P. Murdock, and was analyzed further by Cordain and his collaborators. Cordain is a professor at Colorado State University, and a longtime proponent of paleolithic diets for health. He has written extensively about the detrimental effects of grains and other modern foods. Here's his website.

Egg consumption, serum cholesterol, and cause-specific and all-cause mortality: the National Integrated Project for Prospective Observation of Non-communicable Disease and Its Trends in the Aged, 1980 (NIPPON DATA80). Nakamura Y, Okamura T, Tamaki S, Kadowaki T, Hayakawa T, Kita Y, Okayama A, Ueshima H; NIPPON DATA80 Research Group. Am J Clin Nutr. 2004 Jul;80(1):58-63. PMID: 15213028 In men, egg consumption was not related to age-adjusted total cholesterol. Cox analysis found that, in women, all-cause mortality in the 1-2-eggs/wk group was significantly lower than that in the 1-egg/d group, whereas no such relations were noted in men. CONCLUSION: Limiting egg consumption may have some health benefits, at least in women in geographic areas where egg consumption makes a relatively large contribution to total dietary cholesterol intake.

Since its launch in 2003, Nutrition Data has grown into one of the most authoritative and useful sources of nutritional analysis on the Web. In July 2006, Nutrition Data was acquired by CondéNet, a digital publisher under the Condé Nast Publications umbrella dedicated to editorial excellence. Nutrition Data's continuing goal is to provide the most accurate and comprehensive nutrition analysis available, and to make it accessible and understandable to all.\nThe information in Nutrition Data's database comes from the USDA's National Nutrient Database for Standard Reference and is supplemented by listings provided by restaurants and food manufacturers.

Egg consumption, serum cholesterol, and cause-specific and all-cause mortality: the National Integrated Project for Prospective Observation of Non-communicable Disease and Its Trends in the Aged, 1980 (NIPPON DATA80). Nakamura Y, Okamura T, Tamaki S, Kadowaki T, Hayakawa T, Kita Y, Okayama A, Ueshima H; NIPPON DATA80 Research Group. Am J Clin Nutr. 2004 Jul;80(1):58-63. PMID: 15213028 Results: The subjects were categorized into 5 egg consumption groups on the basis of their responses to a questionnaire (≥2/d, 1/d, 1/2 d, 1-2/wk, and seldom). There were 69, 1396, 1667, 1742, and 315 women in each of the 5 groups, respectively. Age-adjusted total cholesterol (5.21, 5.04, 4.95, 4.91, and 4.92 mmol/L in the 5 egg consumption categories, respectively) was related to egg consumption (P < 0.0001, analysis of covariance). In women, unadjusted IHD mortality and all-cause mortality differed significantly between the groups [IHD mortality: 1.1, 0.5, 0.4, 0.5, and 2.0 per 1000 person-years, respectively (P = 0.008, chi-square test); all-cause mortality: 14.8, 8.0, 7.5, 7.5, and 14.5 per 1000 person-years, respectively (P < 0.0001, chi-square test)]. In men, egg consumption was not related to age-adjusted total cholesterol. Cox analysis found that, in women, all-cause mortality in the 1-2-eggs/wk group was significantly lower than that in the 1-egg/d group, whereas no such relations were noted in men. Conclusion: Limiting egg consumption may have some health benefits, at least in women in geographic areas where egg consumption makes a relatively large contribution to total dietary cholesterol intake.

Dr. Milne presented data which showed that SRT501, Sirtris' proprietary formulation of resveratrol, reduces glucose and improves insulin sensitivity in multiple pre-clinical models of Type 2 Diabetes. Dr. Milne also presented pharmacokinetic (PK) data fro

Nutritional Situation of the Elderly in the European Union: Data of the European Nutrition and Health Report (2004) Elisabeth Fabian, Ibrahim Elmadfa Ann Nutr Metab 2008;52 (Suppl. 1):57-61 (DOI: 10.1159/000115352)

Hypovitaminosis D in British adults at age 45 y: nationwide cohort study of dietary and lifestyle predictors. Hyppönen E, Power C. Am J Clin Nutr. 2007 Mar;85(3):860-8. PMID: 17344510 Conclusion: Prevalence of hypovitaminosis D in the general population was alarmingly high during the winter and spring, which warrants action at a population level rather than at a risk group level. Data from the 1958 birth cohort suggest that, at different cutoffs for hypovitaminosis D, a substantial public health problem exists in British whites. Obese participants and those living in Scotland were at the highest risk of hypovitaminosis D. However, the prevalence in the general population was very high during the winter and spring, which suggests that, to improve the situation, action is required at a population level rather than at a risk-group level. In the United States, calls have gone out for an increase in vitamin D fortification of foods (11), and the data from the current study suggest that such action is also warranted in the United Kingdom. Vitamin D is currently available without prescription as a dietary supplement only as part of cod liver oil or multivitamin products; hence, a need clearly exists to consider increased availability of over-the-counter supplements. Hypovitaminosis D has been implicated in the development of serious conditions, including diabetes, various types of cancer, and cardiovascular diseases, in addition to its essential role in maintaining bone health (1, 2). The high rates of hypovitaminosis D reported in this study suggest that immediate action is needed to improve the vitamin D status of the British population.

Together, the earlier data and the data of Heaney et al indicate that an oral dose of vitamin D2 or vitamin D3 would lead to a comparable increase in circulating 25(OH)D concentrations in children and adults when the initial 25(OH)D3 concentrations in the groups are similar and when equivalent oral vitamin D doses expressed per kilogram body weight/d are given. Serum 25-hydroxyvitamin D response to oral vitamin D intake in children. Zittermann A. Am J Clin Nutr. 2003 Sep;78(3):496-7. PMID: 12936937

Demographic differences and trends of vitamin D insufficiency in the US population, 1988-2004. Ginde AA, Liu MC, Camargo CA Jr. Arch Intern Med. 2009 Mar 23;169(6):626-32. PMID: 19307527 Conclusions National data demonstrate a marked decrease in serum 25(OH)D levels from the 1988-1994 to the 2001-2004 NHANES data collections. Racial/ethnic differences have persisted and may have important implications for known health disparities. Current recommendations for vitamin D supplementation are inadequate to address the growing epidemic of vitamin D insufficiency.

Nut consumption and risk of heart failure in the Physicians' Health Study I. Djoussé L, Rudich T, Gaziano JM. Am J Clin Nutr. 2008 Oct;88(4):930-3. PMID: 18842778 Conclusion: Our data do not provide evidence for an association between nut consumption and incident heart failure in US male physicians. However, our data cannot rule out possible benefits of nut consumption on subtypes of heart failure not prevalent in this cohort.

Demographic differences and trends of vitamin D insufficiency in the US population, 1988-2004. Ginde AA, Liu MC, Camargo CA Jr. Arch Intern Med. 2009 Mar 23;169(6):626-32. PMID: 19307527 Conclusions National data demonstrate a marked decrease in serum 25(OH)D levels from the 1988-1994 to the 2001-2004 NHANES data collections. Racial/ethnic differences have persisted and may have important implications for known health disparities. Current recommendations for vitamin D supplementation are inadequate to address the growing epidemic of vitamin D insufficiency.

Combination immunotherapy of squamous cell carcinoma of the head and neck: a phase 2 trial. Barrera JL, Verastegui E, Meneses A, Zinser J, de la Garza J, Hadden JW. Arch Otolaryngol Head Neck Surg. 2000 Mar;126(3):345-51. PMID: 10722007 The natural cytokine mixture is a collection of natural human cytokines induced from human peripheral blood mononuclear cells. It contains IL-1, IL-2, IL-6, IL-8, IL-10, IL-12, interferon gamma, tumor necrosis factor , and granulocyte-macrophage and granulocyte colony-stimulating factor in nanogram quantities. It lacks IL-3, IL-4, IL-5, and IL-7. [...] This IRX-2 strategy uses perilymphatic local administration along with contrasuppression with low-dose cyclophosphamide and indomethacin and with zinc replacement therapy (as an immunorestorative). The data presented herein demonstrate that H&N SCC can respond very well to immunotherapy: there was a response rate of 100% in this series of 15 patients, with clinical reduction in tumor (1 complete response, 7 partial responses, and 7 minor responses) and histological evidence of tumor regression of 42%. Overall, the average combined estimated tumor reduction exceeded 70%. Also, patients with oral cancer noted marked analgesic and hemostatic effects from this therapy, with healing of oral lesions. [...] It is important to note that adjuvant chemotherapy is not used at INCAN. Many studies23 indicate that treatment with fluorouracil and cisplatin, the combination most in use, is effective for reducing tumors in the majority of patients; however, with no meaningful impact on survival, their routine use in the United States has recently been questioned.24-25 The expense, toxic effects, and lack of effectiveness of both drugs has made their use in other less affluent countries unwarranted. The current data on the use of IRX-2 in this and other protocols8-10 hint at improved survival, and a phase 3 randomized controlled study comparing this protocol with chemotherapy arm is to be initiat

Are omega-3 fatty acids options for prevention and treatment of cognitive decline and dementia? Cederholm T, Palmblad J. Curr Opin Clin Nutr Metab Care. 2009 Dec 16. [Epub ahead of print] PMID: 20019606 PURPOSE OF REVIEW: To report recent data on the potential role of omega-3 fatty acids (n-3 FA) found in oily fish, especially docosahexaenoic acid (DHA), to prevent and treat cognitive decline and Alzheimer's disease. RECENT FINDINGS: Observational studies still provide conflicting results, in which the majority indicate beneficial effects on cognition, both when assessed as a continuous variable or as incident dementia, mainly Alzheimer's disease. Experimental studies have demonstrated potentially ameliorating effects of eicosapentaenoic acid (EPA) and DHA on amyloid fragment formation, signal transduction including upregulation of the apolipoprotein receptor SorLA, as well as on angiogenesis. The role of EPA and DHA metabolites on Alzheimer's disease pathology is under investigation. Recently, three randomized intervention studies, with duration up to 6 months have been reported. In contrast to a small study from Taiwan, no positive overall effects were reported from the Swedish OmegAD Study or from a Dutch study, although post hoc analyses indicate that selected individuals with mild forms of Alzheimer's disease or cognitive decline may respond to treatment. SUMMARY: No firm conclusions can be drawn. Based on epidemiological data, fish including oily fish could be advised as part of a balanced diet for public health purpose, although the evidence for better cognition is only fairly consistent. It is unlikely that n-3 FA will emerge as a treatment option in general for improving cognitive function in patients with Alzheimer's disease. n-3 FA, especially DHA, may turn out as an adjuvant therapy in selected cases. Further long-term intervention studies on individuals with mild cognitive reductions are awaite"

"High blood levels of leptin, a hormone that regulates appetite, may guard against Alzheimer's disease, new research suggests. "Hopefully, in 10 or 15 years this may be one of many agents that we use to reduce the risk of Alzheimer's disease," said senior study author Dr. Sudha Seshadri, an associate professor of neurology at Boston University School of Medicine. "Or it may be one of many markers that we measure in combination to predict risk." But many more studies of different population groups are needed to determine whether leptin can play such a pivotal role in predicting the risk of Alzheimer's, Seshadri said. The research, which was reported in the Dec. 16 issue of the Journal of the American Medical Association, was done because "there has been some data relating body weight to the risk of Alzheimer's disease," Seshadri said. "When we looked at animal studies, we found some data to indicate that leptin not only produces a feeling of satiety but also has a beneficial effect on the hippocampus. It was important to see if that was true in humans." The hippocampus is a portion of the brain that plays a role in important aspects of memory."

Vegetarianism is the practice of following a diet based on plant-based foods including fruits, vegetables, cereal grains, nuts, and seeds, with or without dairy products and eggs.[1] A vegetarian does not eat meat, game, poultry, fish, crustacea, shellfish, or products of animal slaughter such as animal-derived gelatin and rennet.[1][2][3] A vegan diet is a form of vegetarian diet which excludes all animal products, including dairy products, eggs, and honey. A lacto-vegetarian diet includes dairy products but excludes eggs, an ovo-vegetarian diet includes eggs but not dairy products, and a lacto-ovo vegetarian diet includes both eggs and dairy products. Vegetarianism may be adopted for ethical, health, environmental, religious, political, cultural, aesthetic, economic, or other reason A 1999 metastudy[22] combined data from five studies from western countries. The metastudy reported mortality ratios, where lower numbers indicated fewer deaths, for fish eaters to be .82, vegetarians to be .84, occasional meat eaters to be .84. Regular meat eaters and vegans shared the highest mortality ratio of 1.00. The study reported the numbers of deaths in each category, and expected error ranges for each ratio, and adjustments made to the data. However, the "lower mortality was due largely to the relatively low prevalence of smoking in these [vegetarian] cohorts". Out of the major causes of death studied, only one difference in mortality rate was attributed to the difference in diet, as the conclusion states: "vegetarians had a 24% lower mortality from ischemic heart disease than nonvegetarians, but no associations of a vegetarian diet with other major causes of death were established."[2

"Rachel Huxley, D.Phil, of The George Institute for International Health, University of Sydney, Australia, and colleagues identified 18 studies involving 457,922 participants and assessing the association between coffee consumption and diabetes risk published between 1966 and 2009. Six studies involving 225,516 individuals also included information about decaffeinated coffee, whereas seven studies with 286,701 participants reported on tea consumption. When the authors combined and analyzed the data, they found that each additional cup of coffee consumed in a day was associated with a 7 percent reduction in the excess risk of diabetes. Individuals who drank three to four cups per day had an approximately 25 percent lower risk than those who drank between zero and two cups per day. Rachel Huxley, D.Phil, of The George Institute for International Health, University of Sydney, Australia, and colleagues identified 18 studies involving 457,922 participants and assessing the association between coffee consumption and diabetes risk published between 1966 and 2009. Six studies involving 225,516 individuals also included information about decaffeinated coffee, whereas seven studies with 286,701 participants reported on tea consumption. When the authors combined and analyzed the data, they found that each additional cup of coffee consumed in a day was associated with a 7 percent reduction in the excess risk of diabetes. Individuals who drank three to four cups per day had an approximately 25 percent lower risk than those who drank between zero and two cups per day."

A preliminary study of the safety, feasibility and cognitive efficacy of soy isoflavone supplements in older men and women. Gleason CE, Carlsson CM, Barnet JH, Meade SA, Setchell KD, Atwood CS, Johnson SC, Ries ML, Asthana S. Age Ageing. 2009 Jan;38(1):86-93. Epub 2008 Dec 2. PMID: 19054783 doi:10.1093/ageing/afn227 Conclusions: these data suggest that administration of 100 mg/day of isoflavones was well tolerated. Plasma genistein and daidzein levels, but not equol, increased with isoflavone administration. Finally, data support the potential cognitive effects of soy isoflavones in older adults.

Americans, at least as a group, may have reached their peak of obesity, according to data the Centers for Disease Control and Prevention released Wednesday.

Conjugated linoleic acid promotes human adipocyte insulin resistance through NFkappaB-dependent cytokine production. Chung S, Brown JM, Provo JN, Hopkins R, McIntosh MK. J Biol Chem. 2005 Nov 18;280(46):38445-56. Epub 2005 Sep 9. PMID: 16155293 doi: 10.1074/jbc.M508159200 Collectively, these data demonstrate for the first time that trans-10, cis-12 CLA promotes NFkappaB activation and subsequent induction of IL-6, which are at least in part responsible for trans-10, cis-12 CLA-mediated suppression of peroxisome proliferator-activated receptor gamma target gene expression and insulin sensitivity in mature human adipocytes. In summary, our in vitro data demonstrate that a physiological level of trans-10, cis-12 CLA activates NFκB- and ERK1/2-dependent cytokine production, which together suppress PPARγ and Glut4 levels and lead to impaired glucose uptake. Studies are currently under way examining 1) how CLA regulates PPARγ and the expression of its target genes, 2) the specific signaling role of SV cells and adipocytes in mediating the TG-lowering actions of CLA, and 3) the CLA-induced, upstream signal that activates NFκB and ERK1/2.