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Some randomized controlled trials have shown the Paleo diet to produce greater short-term benefits than diets based on national nutrition guidelines, including greater weight loss, reduced waist circumference, decreased blood pressure, increased insulin sensitivity, and improved cholesterol. However these studies were of short duration (6 months or less) with a small number of participants (less than 40). [4-6]
The WHO trial (so named because the international team of principal investigators contained World Health Organization members) tested the potential of clofibrate, a “pre-statin” cholesterol-lowering agent, to reduce heart attack morbidity and mortality. The investigators ultimately concluded that clofibrate "cannot be recommended as a lipid-lowering drug for community-wide primary prevention of ischaemic heart disease.” Nevertheless, clofibrate remained in use until 2002, when it was pulled for increasing cancer rates. In their review of studies such as the WHO trial, Uffe Ravnskov and David Diamond observe, “Despite the largely disappointing findings from 50 years of cholesterol lower[ing] trials, the indictment and conviction of cholesterol as the causal agent in CVD [cardiovascular disease] has stood the test of time. … [Yet] the grand effort to reduce cholesterol as a strategy to improve health has failed.”