Seven Countries Study
The Seven Countries Study is an epidemiological longitudinal study directed by Ancel Keys at what is today the University of Minnesota Laboratory of Physiological Hygiene & Exercise Science (LPHES). Begun in 1956 with a yearly grant of US$200,000 from the U.S. Public Health Service, the study was first published in 1970 and then followed up on its subjects every five years thereafter.
As the world's first multicountry epidemiological study, it systematically examined the relationships between lifestyle, diet, coronary heart disease and stroke in different populations from different regions of the world. It directed attention to the causes of coronary heart disease and stroke, but also showed that an individual’s risk can be changed.
As of 2016, heated scientific debate continues. Project officer Henry Blackburn wrote in 1975, "Two strikingly polar attitudes persist on this subject, with much talk from each and little listening between." Describing online comments on his review of a book about the Atkins diet, T. Colin Campbell wrote in 2014 that "...an irrationality...infuses both sides of this debate (better characterized as a shouting match)." Ian Leslie quotes a sympathetic colleague at the University of Minnesota who said Keys was "critical to the point of skewering”.
In the 1940s, a University of Minnesota researcher, Ancel Keys, postulated that the apparent epidemic of heart attacks in middle-aged American men was related to their mode of life and possibly modifiable physical characteristics. He first explored this idea in a group of Minnesota business and professional men (executives aged 45 to 55) that he recruited into a prospective study in 1947, the first of many cohort studies eventually mounted internationally. The U.S. Public Health Service agreed to fund the study (and then set up and proceeded to fund the Framingham Heart Study on a larger scale). The Minnesota men were followed through 1981 and the first major report appeared in 1963 after the fifteen-year follow-up study.
The study contributed much to survey methods and confirmed the results of larger studies that reported earlier on the predictive value for heart attack of several characteristics measured in health, the now-traditional risk factors of blood pressure and blood cholesterol level and cigarette smoking. Keys traveled widely with his wife Margaret who tested people's serum cholesterol. They sent their samples back to Minnesota for analysis. In 1952, Keys's hypothesis that coronary heart disease could be related to diet was first published in Voeding in The Netherlands. Keys's work in post-wartime Naples led him to seek organization and funding for studies of different populations, as did his subsequent work in Uganda; Cape Town, South Africa; Sardinia; Bologna; and Ilomantsi, Finland; and with Japanese men living in Hawaii and in Japan. He decided to concentrate on men living in villages, rather than those in cities where the population moved around frequently.
In the mid-1950s, with improved methods and design, Keys recruited collaborating researchers in seven countries to mount the first cross-cultural comparison of heart attack risk in populations of men engaged in traditional occupations in cultures contrasting in diet, especially in the proportion of fat calories of different composition, the Seven Countries Study still under observation today.
The Seven Countries Study was formally started in fall 1958 in Yugoslavia. In total, 12,763 males, 40–59 years of age, were enrolled as 16 cohorts, in seven countries, in four regions of the world (United States, Northern Europe, Southern Europe, Japan). One cohort is in the United States, two cohorts in Finland, one in the Netherlands, three in Italy, five in Yugoslavia (two in Croatia, and three in Serbia), two in Greece, and two in Japan. The entry examinations were performed between 1958 and 1964 with an average participation rate of 90%, lowest in the USA, with 75% and highest in one of the Japanese cohorts, with 100%. The Seven Countries Study has continued for more than 50 years.
The Seven Countries Study showed that the risk and rates of heart attack and stroke cardiovascular risk both at the population level and at the individual level was directly and independently related to the level of total serum cholesterol. It demonstrated that the association between blood cholesterol level and coronary heart disease (CHD) risk from 5 to 40 years follow-up is found consistently across different cultures. Cholesterol and obesity were associated with increased mortality from cancer.
Objective data on CVD health in relation to the Mediterranean diet originated from the Seven Countries Study. Coronary deaths in the United States and Northern Europe greatly exceeded those in Southern Europe, even when controlled for age, cholesterol, blood pressure, smoking, physical activity, and weight. When investigated further, the importance of the eating pattern characterized as the Mediterranean diet became clear. What exactly is meant by "Mediterranean Diet" today, and its benefits, was detailed by Antonia Trichopoulou and Anna Ferro-Luzzi. The diet was publicized and popularized by Greg Drescher of the Oldways Preservation and Exchange Trust and by Walter Willett of the Harvard School of Public Health.
The Seven Countries Study also showed that the slowly changing habits of a population in the Mediterranean region, from a healthy, active lifestyle and diet, to a less active lifestyle and a diet influenced by the Western pattern diet, significantly increases risk of heart disease. Meanwhile, it has been confirmed by other researchers that there is an inverse association between adherence to the Mediterranean diet and the incidence of fatal and non- fatal heart disease in initially healthy middle-aged adults in the Mediterranean region.
The Seven Countries Study, along with other important large studies, e.g. the Framingham Heart Study, Nurses' Health Study, Women's Health Initiative, confirmed not only the importance of healthy diet, but also of not being overweight or obese, and of regular exercise, in maintaining good general health. It also showed that regular exercise and dietary fibre strongly influence body fat levels. These and other research findings made it possible to calculate the probability of an individual developing coronary heart disease in the future.
The Seven Countries Study demonstrated that elevated blood pressure (hypertension) increases risk of coronary heart disease and stroke. It showed that the mortality rate after a coronary heart disease event or stroke can be influenced by the level of hypertension. In several cohorts of the study, stroke deaths exceeded deaths from coronary heart disease.
The Seven Countries Study showed that differences in overall mortality between the different regions of the world are largely accounted for by the variation in cardiovascular mortality.
The Seven Countries Study confirmed that cigarette smoking is a highly significant predictor of the development of coronary heart disease, leading to excess rates of angina pectoris, myocardial infarction (MI), and coronary death, along with other important studies about smoking, e.g. the Framingham Heart Study and the British Doctors Study.
The Seven Countries Study revealed the importance of good cardiovascular health in avoiding dementia in the general population. It also showed that cardiovascular risk factors in mid life are significantly associated with increased risk of dementia death later in life.
Scientists differed on the best predictors of heart disease. In the history according to Gary Taubes, in 1950 in Science, John Gofman described separating lipoproteins into different densities in the University of California, Berkeley, ultracentrifuge. In 1952 as part of a panel with Keys, Gofman agreed that reducing fat in the diet might help some heart patients (and in this same issue of Circulation Keys explained that dietary cholesterol is not a factor in humans). In 1956 Gofman wrote that an atherogenic index (the combined levels of LDL and VLDL) predicted atherosclerosis and heart disease. In 1958 he wrote, "The serum cholesterol measurement can be a dangerously misleading guide in evaluation of the effect of diet upon the serum lipids."
Some offered hypotheses opposed to Keys. In 1966, based on their work and writing since 1956, George Campbell and Thomas L. Cleave published Diabetes, Coronary Thrombosis and the Saccharine Disease. They argued that the chronic Western diseases such as diabetes, heart disease, obesity, peptic ulcers and appendicitis are caused by one thing: "refined carbohydrate disease". In 1957 a distinguished pioneer in lipid research, Edward H. "Pete" Ahrens, Jr., warned of oversimplifying the problem of diet and heart disease, saying the cause could be fat and cholesterol or it could be carbohydrates and triglycerides. Until evidence was produced, he questioned "the wisdom of prescribing low-fat diets for the general population."
Even before the study had begun, there had been criticism of its methods. Jacob Yerushalmy and Herman E. Hilleboe pointed out that, for an earlier study demonstrating this association, Keys had selected six countries out of 21 for which data were available. Analysis of the full dataset made the analysis between fat intake and heart disease less clear. In 1957 when they published their critique, Yerushalmy and Hilleboe seemed to some to be lecturing, "the association between the percentage of fat calories... and mortality from... heart disease is not valid" and then they call Keys's work a "tenuous association". Keys, who was one of the first nutrition epidemiologists, wrote in every journal article that "causal relationships are not claimed". His reaction was to mount the Seven Countries Study, the first multicountry epidemiological study ever done.
Several scientists stepped forward at the time to disagree with Keys's conclusions. Published in 1973 and including his critique of Keys's work, Raymond Reiser found methodological and interpretational errors in a review of forty trials. Ahrens found separately with Margaret Albrink that triglycerides mattered in coronary disease more than total cholesterol, and came to think that carbohydrates cause heart disease and not fats. Although he is widely misquoted to this day (for example in Breitbart), George V. Mann did not say in the New England Journal of Medicine (NEJM) in 1977 that the lipid theory is "the greatest scam in the history of medicine". Mann studied the mainly meat diet of Alaskan Eskimos, Congolese pygmies, and the Maasai of Tanzania and Kenya, and thought other factors like lack of exercise were responsible for heart disease. In NEJM in 1977, he dismissed Keys's work of 1953, "The naïveté... is now a classroom demonstration."
John Yudkin thought that sugar, not fat, was at the root of heart disease and other human ills. Keys wrote and promoted his disagreement in 1971. The next year Yudkin retired to write Pure, White and Deadly.
Debate since 2000
In his 2009 video Sugar: The Bitter Truth, Robert Lustig says his purpose is to debunk the prior thirty years of nutrition research, specifically Keys. Lustig gave details in his book Fat Chance: that Keys cherry-picked seven of 22 countries; consumption of trans-fat peaked in the 1960s and Keys failed to separate them out; results for Japan and Italy could be explained by either low saturated fat consumption or by low sugar consumption; and Keys wrote that sucrose and saturated fat were intercorrelated but failed to perform the sucrose half of his multivariate correlation analysis.
Controversy continues about the study itself, and about the strength and causality of the association between dietary fat and heart mortality, particularly as the study of cholesterol has become more sophisticated. Reigniting the debate was a meta-analysis in 2014 finding that "current evidence does not clearly support cardiovascular guidelines that encourage high consumption of polyunsaturated fatty acids and low consumption of total saturated fats". However, this meta-study has also met with controversy and was corrected, with Willett continuing to defend reduced saturated fat in the diet.
James J DiNicolantonio, one of the associate editors of BMJ's Open Heart, authored or co-authored a number of papers in 2014 with scientists who believe a diet including saturated fat does no harm to human hearts. Lustig, Yudkin, and DiNicolantonio mention Keys by name and most mention the Seven Countries Study, as do recent books by two journalists, Gary Taubes and Nina Teicholz.
Taubes wrote two bestsellers, Good Calories, Bad Calories in 2007 followed by Why We Get Fat in 2010–2011. Part I of Good Calories, Bad Calories relates how we came to believe dietary fat causes heart disease (Part II offers that carbohydrates cause the chronic diseases of civilization, and Part III explains obesity and calories). Adding interviews, Teicholz's The Big Fat Surprise closely follows Taubes Part I, urging a second look at the idea that saturated fat causes heart disease.
Taubes became a regular contributor to The New York Times opinion pages and twice the paper gave Taubes a lead feature story in its Sunday magazine: "What if It's All Been a Big Fat Lie?" (2002) and "Is Sugar Toxic?" (2011).
Campbell, who mentions the Seven Countries Study and recounts meeting Keys twice, calls Taubes "by far, the most eloquent and influential present-day spokesperson for the low-carb movement." In his book, The Low-Carb Fraud (2014), Campbell says that Taubes was right to "demolish" the counting calories myth, and that his history of the past five decades of nutrition science is well done (although later termed a distortion). An advocate for a whole food plant-based (WFPB) diet, Campbell points out that Taubes uses "a bit of sleight of hand" to say that, "refined sugar is bad, therefore all foods that contain sugars (i.e. carbs) are bad."
In September 2014, Frank Hu led the 2015 Dietary Guidelines Advisory Committee's report on saturated fat and cardiovascular disease. Alice H. Lichtenstein said that the consensus is that a low-fat diet is "probably not a good idea" and that it might induce dyslipidemia. She said that the guidelines had changed (formerly recommending low fat, and now moderate fat) in 2000, and that the American Heart Association and the National Heart, Lung, and Blood Institute had revised guidelines as of 2000. The group's Scientific Report of the 2015 Dietary Guidelines Advisory Committee says the average person in the U.S. consumes too much saturated fat. "Sources of saturated fat should be replaced with unsaturated fat, particularly polyunsaturated fatty acids."
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