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I predict that this simple and feasible project proposal which will alleviate a host of different modern ailments will be rejected by any mainstream health care system which relies heavily on Big Pharma’s budget and its status quo.

Summary

It is increasingly recognized that certain fundamental changes in diet and lifestyle that occurred after the Neolithic Revolution, and especially after the Industrial Revolution and the Modern Age, are too recent, on an evolutionary time scale, for the human genome to have completely adapted. This mismatch between our ancient physiology and the western diet and lifestyle underlies many so-called diseases of civilization, including coronary heart disease, obesity, hypertension, type 2 diabetes, epithelial cell cancers, autoimmune disease, and osteoporosis, which are rare or virtually absent in hunter–gatherers and other non-westernized populations. It is therefore proposed that the adoption of diet and lifestyle that mimic the beneficial characteristics of the preagricultural environment is an effective strategy to reduce the risk of chronic degenerative diseases. Giving support to this notion, human intervention trials have demonstrated that a diet composed of meat, fish, shellfish, eggs, fresh fruit and vegetables, roots, tubers, nuts, and seeds may be superior to so-called healthy diets such as a low fat diet. The aim of this project proposal is to reproduce these results at the Primary Care level in a healthy population whose traditional diet included animal products and only until recently has adhered to industrialized low fat foods.

Background

On September 2011, the United Nations declared that, for the first time in human history, chronic non-communicable diseases such as heart disease, cancer and diabetes pose a greater health burden worldwide than do infectious diseases, contributing to 35 million deaths annually. [1] This is not just a problem of the developed world. Every country that has adopted the Western diet — one dominated by low-cost, highly processed food — has witnessed rising rates of obesity and related diseases.

According to the CDC, about one-third of U.S. adults (33.8%) are obese and approximately 17% (or 12.5 million) of children and adolescents aged 2 – 19 years are obese. In 2010, no state had less than 20% obesity prevalence. Another statistic tells us that over two-thirds of adults in the United States are overweight or obese.

Available population data in Spain from the SEEDO’2000 study show a prevalence of obesity (BMI > or = 30 kg/m(2)) of 14,5% in adults aged 25-60 years, estimates based on individual measurement of body weight and height. [2]

Worldwide, with the spread of Western lifestyle (including diet), obesity has more than doubled since 1980. In 2008, 1.5 billion adults, 20 and older, were overweight and nearly 43 million children under the age of five were overweight in 2010.

Aside from quantitative over-consumption, various macronutrients have been postulated to contribute to the metabolic syndrome. Some suggest that specific dietary fats, such as saturated and trans-fats, are the culprit, while others suggest that a deficiency of monounsaturated lipids, such as olive oil (oleic acid) or linoleic acid, are implicated. However, our absolute consumption of dietary fat has not changed in these last 30 years, and high-fat, low-carbohydrate diets appear to be protective against the metabolic syndrome [3].

Over the past 50 years, consumption of sugar has tripled worldwide. In the United States, there is fierce controversy over the pervasive use of one particular added sugar — high-fructose corn syrup (HFCS). It is manufactured from corn syrup (glucose), processed to yield a roughly equal mixture of glucose and fructose. Most other developed countries eschew HFCS, relying on naturally occurring sucrose as an added sugar, which also consists of equal parts glucose and fructose. A growing body of scientific evidence shows that fructose can trigger processes that lead to liver toxicity and a host of other chronic diseases. [3]  A growing body of epidemiological and mechanistic evidence argues that excessive sugar consumption affects human health beyond simply adding calories. Importantly, sugar induces all of the diseases associated with metabolic syndrome. This includes: hypertension (fructose increases uric acid, which raises blood pressure); high triglycerides and insulin resistance through synthesis of fat in the liver; diabetes from increased liver glucose production combined with insulin resistance; and the aging process, caused by damage to lipids, proteins and DNA through non-enzymatic binding of fructose to these molecules. Data from prospective and intervention studies clearly point to high fructose consumption, mainly in the form of sweetened beverages, as a risk factor for several metabolic diseases. [4] The role of fructose and sucrose (which is 50% fructose) in metabolic disorders has been reviewed extensively. Dietary fructose consumption in industrialized countries has increased in parallel with the increase in fatty liver, obesity, and diabetes and there is a direct association. The increased consumption of high fructose corn syrup, primarily in the form of soft drinks, is linked with complications of the metabolic syndrome and an increase in liver enzymes. Unlike glucose, fructose stimulates de novo fatty acid synthesis directly and promotes weight gain. Fructose is also different from glucose in its ability to induce features of metabolic syndrome (insulin resistance, fatty liver, dyslipidemia, and intra-abdominal fat accumulation) both in humans and laboratory animals. The mechanism whereby fructose induces fatty liver appears to be independent of total energy intake.[5]

People who get at least 25% of their daily calories from added sugars of any kind -fructose or other sugar sweeteners used by the food industry and consumers as ingredients in processed or prepared foods – are 3.1 times more likely to have low levels of so-called good cholesterol in their bloodstream than people who get less than 5% of their calories from added sweeteners. Additionally, those who consume more than 17.5% of their calories from the sugars — be it ordinary table sugar derived from sugar cane or sugar beets, high fructose corn syrup or any other caloric sweetener —are 20% to 30% more likely to have high levels of blood fats called triglycerides than people with the low-sugar diets. [6]

It is recognized that the change in diet since the Agricultural Revolution, Industrial Revolution and the Modern Age has systemically destroyed our health and that the mismatch between our ancient physiology and current diet is at the root of many so-called diseases of civilization: coronary heart disease, obesity, hypertension, type-2 diabetes, cancer, autoimmune disease, osteoporosis, etc. which are virtually absent in hunter-gatherers and non-westernized populations.[7] Most of the human genome has ancestral genes that adapted for over millions of years to a caveman diet.

Low-carb ketogenic diets are effective for weight loss, seizure disorders, and a host of other neurological diseases. Attention has focused on the use of low carb diets and their efficacy in controlling metabolic diseases including obesity and fatty liver.[8] Moreover, a meta-analysis of prospective epidemiological studies showed that there is no significant evidence for concluding that dietary saturated fat is associated with an increased risk of cardiovascular disease.[9]

Even short-term consumption of a paleolithic type diet improves blood pressure and glucose tolerance, decreases insulin secretion, increases insulin sensitivity and improves lipid profiles without weight loss in healthy sedentary humans. [10]

I consider it essential to reproduce the results of these studies at a Primary Care Level which oversees the care of people and aims the prevention of metabolic syndrome, obesity and modern chronic diseases.

Hypothesis

The contemporary Western diet figures centrally in the pathogenesis of numerous chronic diseases-‘diseases of civilization’. The main hypothesis is that a diet similar to that consumed by our preagricultural hunter-gatherer ancestors (that is, a paleolithic type diet) confers health benefits in a healthy population.

Planned methods

The aim is to make an assessment of the effects in healthy volunteers by a 1 month intervention study with paleolithic diet on anthropometric and metabolic parameters. The diet concept will not be an attempt to copy stone-age eating habits in a historically correct manner, but rather to eliminate some of the harmful aspects of modern affluent diets including its rich content in fructose and processed foods, and extract some health benefits from readily available foods, using an evolutionary paradigm as a guide and encouraging traditional foods that are animal based.

Twenty volunteers aged 20–60 years will be recruited via a primary health care system. Subjects will either follow a normal diet (n=10 individuals) or a paleolithic diet (n=10 individuals). Exclusion criteria: Disease requiring hospital care or prescription drugs (exception: antihistamines), pregnancy, full-time breastfeeding, body mass index (BMI) above 30, eating disorder, special other diet. All subjects will be trained by the author on how to do the diet during domiciliary visits and the patients will register their entire food intake in a diary. Participants will be given a list of approximate weights of ingredients.

Subjects will be tested in two occasions, before starting the diet and after the intervention period (4 weeks). Weight, height, waist circumference and blood pressure will be measured in the horizontal position after 5 minutes rest. All of these parameters will be tested by the author. Fasting blood tests will be drawn (after 12 h fasting) for hemoglobin, high-sensitive C-reactive protein, fasting blood glucose, lipids, fibrinogen, uric acid and glycated hemoglobin. Capillary ketone levels will be tested by the author.

Allowed food ad libitum: All fresh or frozen vegetables except legumes, canned tomatoes without additives except for citric acid, fresh or frozen fish and seafood, fresh or frozen lean meats and minced meat, unsalted nuts (except peanuts), fresh squeezed lemon or lime juice (as dressing), olive oil (as dressing), coffee and tea (without sugar, honey, milk or cream), non-processed spices.

Allowed food in restricted quantity: Fat meat (two meals/week), potatoes (two medium sized/week), honey (used in marinade once/week), cured meats (as entre´s once/week), mineral water (only when drinkable tap water was not available). All fresh or frozen fruits and berries (four portions/week).

Prohibited food: All milk and dairy products, all grain products (including maize and rice), all legumes (including peanuts), charcuterie products (for example, sausages, pâte´s and so forth), canned food (except tomatoes, see above) and all forms of candy, ice cream, sorbet, soft drinks, juices, syrups, liquor, and sugar.

Statistical calculations will be performed by Stata version 9.0. Comparisons will be performed by Student’s paired t-test and Wilcoxon’s paired test.

Approval by an ethics committee will be mandatory.

Potential Impact

Optimal dietary recommendations are still a matter of debate. Since nutritional science is hampered by confounders, an evolutionary approach has been suggested. It is postulated that foods that were regularly eaten during human evolution, in particular during the Paleolithic (the ‘Old Stone Age,’ 2.5–0.01 million years BP), may be optimal to prevent insulin resistance and glucose intolerance. [11] Traditional Pacific Islanders of Kitava, Papua New Guinea, had no signs of ischemic heart disease, stroke or markers of the metabolic syndrome despite their animal based diet, possibly because of their traditional lifestyle [12]. Our evolutionary diet has been traditionally rich in animal based foods in times when obesity was not as prevalent as it is today.

With this study, I expect to find a decrease in mean weight, BMI, waist circumference, systolic blood pressure, glycated hemoglobin and fasting glucose levels. I hope to show favorable effects on cardiovascular risk factors.
My estimation is that the potential results will add up to the growing body of scientific evidence that modern foods are deteriorating our world’s overburdened health and that traditional foods are the most physiological lifestyle as it was for our ancestors.

Dissemination strategy

I think it is essential to become increasingly familiarized with the role of modern foods in our health and how alienated we have become to traditional foods that saw us thrive in the past. This subject is even more important to Primary Care Attention physicians who are the first line in preventing modern diseases that plague civilization. This study is very practical to make and the patients will be those whom the practitioner already sees in his or her clinical practice in any public health care system.

References

1. Lustig, R.H. et al. The toxic truth about sugar. Nature  2012 Feb 1;482(7383):27-9
2. Pérez-Rodrigo et al. Epidemiology of obesity in Spain. Dietary guidelines and strategies for prevention. Int J Vitam Nutr Res. 2006 Jul 76 (4):163-71.
3. Lustig, R.H. Fructose: Metabolic, Hedonic, and Societal Parallels with Ethanol J. Am. Diet. Assoc. 110, 1307-1321 (2010).
4. Rebollo et al. Way back for fructose and liver metabolism: bench side to molecular insights. World J Gastroenterol 2012 December 7; 18(45):6552-6559.
5. Lanaspa et al. Uric Acid Stimulates Fructokinase and Accelerates Fructose Metabolism in the Development of Fatty Liver. PLoS One. 2012; 7(10): e47948.
6. Welsh et al. Caloric Sweetener Consumption and Dyslipidemia Among US Adults. JAMA, April 21, 2010 – Vol 303, N. 15, 1490-1497.
7. Carrera-Bastos P., Fontes-Villalba M., et al. The western diet and lifestyle and diseases of civilization. Research Reports in Clinical Cardiology. 2011:2, 15-35.
8. Schugar et al. Low-carbohydrate ketogenic diets, glucose homeostasis, and nonalcoholic fatty liver disease. Curr Opin Clin Nutr Metab Care 2012, 15: 374-380.
9. Siri-Tarino PW, Sun Q, Hu FB, Krauss RM. Meta-analysis of prospective cohort studies evaluating the association of saturated fat with cardiovascular disease. Am J Cln Nutr. 2010 Mar;91(3):535-46
10. Frassetto L.A. et al. Metabolic and physiologic improvements from consuming a paleolithic, hunter-gatherer type diet. Eur J Clin Nutr. 2009 Aug;63(8):947-55.
11. Eaton S, Konner M (1985) Paleolithic nutrition. A consideration of its nature and current implications. N Engl J Med 1985 Jan 31; 312 (5): 283–289.
12. Lindeberg S, Lundh B. Apparent absence of stroke and ischaemic heart disease in a traditional Melanesian island: a clinical study in Kitava. J Intern Med. 1993 Mar;233(3):269-75.