The Disputed Science on Saturated Fats

EXECUTIVE SUMMARY

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In order to continue the limits on saturated fat, health officials must show ample and consistent evidence that these fats damage health. The principal allegation against them has been that they cause heart disease, according to  the diet-heart hypothesis which was first proposed in the 1950s.[1]

However, rigorous evidence for this hypothesis on saturated fats has long been lacking.

Summary of the data: The rigorous trial data do not support the allegation that saturated fats cause cardiovascular mortality or total mortality. While saturated fats can be shown to raise the “bad” LDL-cholesterol, this elevated risk factor does not result in higher mortality rates, very likely reflecting a more complicated pathway for cardiovascular disease than simply LDL-C (i.e., saturated fats also consistently raise the “good” HDL-cholesterol, which may be a compensating effect).

Regarding the observational evidence, meta-analyses of this data consistently find no association between saturated fat and cardiovascular disease. Moreover, there is a substantial observational finding that low consumption of saturated fats is associated with higher mortality and higher rates of stroke.

The only review of the data that did find a significant negative effect of saturated fats was by the American Heart Association (AHA), which did not look at the more definitive mortality data. It’s important to note that the AHA was the original author, in 1961, of the policy to limit saturated fats as a measure of protection against heart disease, and therefore has a significant interest in defending its longtime institutional position.

With the sole exception of the AHA review, the conclusions of more than a dozen review papers by independent teams of scientists all over the world overwhelmingly do not support continued caps on saturated fats.

Moreover, officials risk doing harm to populations by limiting saturated fats. These fats consistently raise the “good” HDL-C and are the only food known to do so. They are also part of many natural, unprocessed, “whole” foods, such as milk, meat, cheese, etc. that are not only rich in the nutrients considered necessary by health authorities to sustain human life, but also contain these nutrients in their most “bioavailable” form.

Broader perspective: For any naturally occurring food, the default judgement must be that it is innocent until proven guilty. Saturated fats were condemned in the 1950s based on what we now know to be weak and unreliable evidence. Large clinical trials have since failed to support the diet-heart hypothesis. Thus, despite being rigorously tested, this hypothesis cannot be confirmed. Saturated fats cannot be considered guilty, as charged, and therefore, the limits on them should be lifted.

For press reports and expert analyses challenging the hypothesis that saturated fats cause heart disease, click here.

Data on Saturated Fats: overview

There are two types of data that can be consulted on the question of whether saturated fats cause heart disease:

  • Randomized, controlled clinical trials (RCT), which can establish cause and effect and are therefore considered the more rigorous data
  • Epidemiological data, which only show associations and are therefore considered weaker. However, if an association contradicts a hypothesis, this is a strong piece of evidence that the hypothesis is unlikely to be true.

Summary of the RCT data

There have been eight reviews of the RCT evidence looking at mortality outcomes, or “hard outcomes,” and seven of the eight concluded that saturated fats have no effect on cardiovascular or total mortality. The eighth review found that saturated fats had an effect on CVD mortality, but this can be explained by its inclusion of a trial, called The Finnish Mental Health Study, which was non-randomized and poorly controlled (and had findings uniquely negative for saturated fats, thereby skewing the results of the reviews that included this study).

Mortality (death) is a reliable, indisputable outcome. Therefore, these outcomes are considered to be the most definitive.

However, these RCTs also looked at “soft outcomes,” such as heart attacks, chest pain (angina), LDL-C and HDL-C. Nine review papers examined these outcomes, with mixed findings: five found that saturated fats had some effect on CVD/CHD events and three did not. However, of the five ‘negative’ findings, two lost statistical significance when subjected  to more rigorous analyses by the review authors, and four questionably included the Finnish Mental Health Study, which was a non-randomized trial that had unusually negative skewed results against saturated fats.

The American Heart Association’s recent “Presidential Advisory” on saturated fats was an exception to other reviews of the same data. An article published in Medscape covered this issue.

This chart is a summary of this RCT evidence (Note: It includes all the RCT reviews except one. by Ramsden et al)

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 Summary of the observational data

At least three meta-analyses, 3 systematic reviews, and 2 non-systematic reviews, have examined  all the epidemiological data (the kind of evidence that can show association but not causation) and found that saturated fats are not associated with heart disease.

Moreover, the largest and most global epidemiological study, recently published in The Lancet, found that those who ate the largest amount of saturated fats had significantly reduced rates of mortality and that a low consumption of these fats (6-7% of calories, as commonly recommended for people with heart disease) was associated with increased risk of stroke.

 

REVIEWS OF DATA FROM RANDOMIZED CONTROLLED TRIALS:

Meta-analyses and systematic reviews (in chronological order):

Dietary Fat and Coronary Heart Disease: Summary of Evidence From Prospective Cohort and Randomised Controlled Trials” (review of observational data and clinical trials)

Annals of Nutrition and Metabolism (2009)

Skeaff CM, PhD, Professor, Dept. of Human Nutrition, the University of Otago, Miller J.

Conclusions: “Intake of SFA was not significantly associated with CHD mortality, with a RR of 1.14 (95% CI 0.82–1.60, p = 0.431) for those in the highest compared with the lowest category of SFA intake (fig. 6). Similarly SFA intake was not significantly associated CHD events (RR 0.93, 95% CI 0.83–1.05, p = 0.269 for high vs. low categories). Moreover, there was no significant association with CHD death (RR 1.11, 95% CI 0.75–1.65, p = 0.593) per 5% TE increment in SFA intake.”

 

Effects on Coronary Heart Disease of Increasing Polyunsaturated Fat in Place of Saturated Fat: A Systematic Review and Meta-analysis of Randomized Controlled Trials

PLOS Medicine (2010)

Mozaffarian D, Department of Epidemiology, Harvard School of Public Health, Micha R, Department of Epidemiology, Harvard School of Public Health, and Wallace S, Department of Epidemiology, Harvard School of Public Health.

Conclusions: “These findings provide evidence that consuming PUFA in place of SFA reduces CHD events in RCTs. This suggests that rather than trying to lower PUFA consumption, a shift toward greater population PUFA consumption in place of SFA would significantly reduce rates of CHD”

 

Reduced or Modified Dietary Fat For Preventing Cardiovascular Disease” (Systematic Review and Meta-analysis) (Analysis of clinical trials)

Cochrane Database Syst Review (2012), An independent organization of scientists who specialize in systematic reviews. This review is an update on one conducted in 2011.

Hooper L, Norwich Medical School, University of East Anglia, Summerbell CD, Thompson R, et al.

Conclusions: There were no clear effects of dietary fat changes on total mortality, cardiovascular mortality, stroke, total MIs or non-fatal MIs. Reducing saturated fat by reducing and/or modifying dietary fat reduced the risk of cardiovascular events by 14%,” This finding was for men only and disappeared upon the authors “Removing studies with systematic differences in care between intervention and control groups, or other dietary differences.”

 

Association of Dietary, Circulating, and Supplement Fatty Acids with Coronary Risk: A Systematic Review and Meta-analysis” (on observational data on all fatty acids and RCTs on supplementation with polyunsaturated fats, o3s or o6s)

Annals of Internal Medicine (2014)

Rajiv Chowdhury, MD, PhD, University of Cambridge, Samantha Warnakula, University of Cambridge, et al.

Details: RCT data reviewed is on 105,085 participants; observational data is on roughly 550,000 participants. The RCT analysis combined trials that increased either omega 3s or omega 6s.

Conclusion: “Current evidence does not clearly support cardiovascular guidelines that encourage high consumption of polyunsaturated fatty acids and low consumption of total saturated fats.”

 

“Dietary fatty acids in the secondary prevention of coronary heart disease: a systematic review, meta-analysis and meta-regression,” (on clinical trials)

BMJ Open (2014)

Lukas Schwingshackl and Georg Hoffman, Faculty of Life Sciences, Department of Nutritional Sciences, University of Vienna, Vienna, Austria

Details: This paper compares low-fat trials to high-fat trials and only includes those with detailed reporting on cholesterol risk factors. A total of 32 trials on nearly 9,000 participants analyzed.

Conclusion: (looking only at subjects with existing CVD) The present systematic review provides no evidence (moderate quality evidence) for the beneficial effects of reduced/modified fat diets in the secondary prevention of coronary heart disease. Recommending higher intakes of polyunsaturated fatty acids in replacement of saturated fatty acids was not associated with risk reduction.

 

Reduction in saturated fat intake for cardiovascular disease,” (systematic review and meta-analysis of randomized, controlled clinical trials)

Cochrane Database Systematic Review, 2015

Hooper, L. et al.

Details: This is a systematic review and meta-analysis of randomized controlled trials, performed by the Cochrane collaboration – an independent organization of scientists. The trials reviewed include more than 59,000 participants.

Findings: The study found no statistically significant effects of reducing saturated fat on the following outcomes: all-cause mortality, cardiovascular mortality, fatal MIs (myocardial infarctions), non-fatal MIs, stroke, coronary heart disease mortality, coronary heart disease events. The one significant finding was an effect for saturated fats on cardiovascular events. However this finding lost significance when subjected to a sensitivity analysis (Table 8, page 137).

Conclusion: People who reduced their saturated fat intake were just as likely to die, or get heart attacks or strokes, compared to those who ate more saturated fat.

 

Evidence from prospective cohort studies does not support current dietary fat guidelines: a systematic review and meta-analysis

British Journal of Sports Medicine (2016)

Harcombe, Z., Baker, JS, Davies B.

Results: Across 7 studies, involving 89 801 participants (94% male), there were 2024 deaths from CHD during the mean follow-up of 11.9±5.6 years. The death rate from CHD was 2.25%. Eight data sets were suitable for inclusion in meta-analysis; all excluded participants with previous heart disease. Risk ratios (RRs) from meta-analysis were not statistically significant for CHD deaths and total or saturated fat consumption. The RR from meta-analysis for total fat intake and CHD deaths was 1.04 (95% CI 0.98 to 1.10). The RR from meta-analysis for saturated fat intake and CHD deaths was 1.08 (95% CI 0.94 to 1.25).
Conclusions: Epidemiological evidence to date found no significant difference in CHD mortality and total fat or saturated fat intake and thus does not support the present dietary fat guidelines. The evidence per se lacks generalisability for population-wide guidelines.

 

“Re-evaluation of the traditional diet-heart hypothesis: analysis of recovered data from Minnesota Coronary Experiment (1968-73)”

The BMJ  (2016) starting p. 7. (on RCT data)

Details: This paper contains, as a separate piece of research, a systematic review and meta-analysis of clinical trials in which saturated fats were replaced by “oils rich in linoleic acid (such as corn oil, sunflower oil, safflower oil, cottonseed oil, or soybean oil).” (5 trials, 10,808 participants)

Results: “There was no evidence of benefit on mortality from coronary heart disease (hazard ratio 1.13, 95% confidence interval 0.83 to 1.54).”

Conclusion: “Although limited, available evidence from randomized controlled trials provides no indication of benefit on coronary heart disease or all cause mortality from replacing saturated fat with linoleic acid rich vegetable oils.”

 

‘The effect of replacing saturated fat with mostly n-6 polyunsaturated fat on coronary heart disease: a meta-analysis of randomized, controlled trials.”

Nutrition Journal (2017)

Steve Hamley

Results: When pooling results from only the adequately controlled trials there was no effect for major CHD events (RR = 1.06, CI = 0.86–1.31), total CHD events (RR = 1.02, CI = 0.84–1.23), CHD mortality (RR = 1.13, CI = 0.91–1.40) and total mortality (RR = 1.07, CI = 0.90–1.26). Whereas, the pooled results from all trials, including the inadequately controlled trials, suggested that replacing SFA with mostly n-6 PUFA would significantly reduce the risk of total CHD events (RR = 0.80, CI = 0.65–0.98, P = 0.03), but not major CHD events (RR = 0.87, CI = 0.70–1.07), CHD mortality (RR = 0.90, CI = 0.70–1.17) and total mortality (RR = 1.00, CI = 0.90–1.10).

Conclusion: “Available evidence from adequately controlled randomised controlled trials suggest replacing SFA with mostly n-6 PUFA is unlikely to reduce CHD events, CHD mortality or total mortality. The suggestion of benefits reported in earlier meta-analyses is due to the inclusion of inadequately controlled trials. These findings have implications for current dietary recommendations.”

 

Dietary Fats and Cardiovascular Disease: A Presidential Advisory From the American Heart Association.

Circulation (the journal of the American Heart Association, original authors of the diet-heart policy for Americans)

Sacks FM, Lichtenstein AH, Wu JHY et al., for the American Heart Association.

Conclusions:  In summary, randomized controlled trials that lowered intake of dietary saturated fat and replaced it with polyunsaturated vegetable oil reduced CVD by ≈30%...,Prospective observational studies in many populations showed that lower intake of saturated fat coupled with higher intake of polyunsaturated and monounsaturated fat is associated with lower rates of CVD and of other major causes of death and all-cause mortality….Replacement of saturated with unsaturated fats lowers low-density lipoprotein cholesterol, a cause of atherosclerosis, linking biological evidence with incidence of CVD in populations and in clinical trials….[W]e conclude strongly that lowering intake of saturated fat and replacing it with unsaturated fats, especially polyunsaturated fats, will lower the incidence of CVD.

 

Non-systematic reviews:

Saturated Fat, Carbohydrate, and Cardiovascular Disease” (Review of clinical trials)

American Journal of Clinical Nutrition (2010)

Siri-Tarino PW, Children’s Hospital, Oakland Research Institute Oakland, Sun Q, MD, Departments of Nutrition and Epidemiology, Harvard School of Public Health, Hu FB, MD, Departments of Nutrition and Epidemiology, Harvard School of Public Health, et al.

Conclusions: “Although substitution of dietary polyunsaturated fat for saturated fat has been shown to lower CVD risk, there are few epidemiologic or clinical trial data to support a benefit of replacing saturated fat with carbohydrate.”

 

DATA FROM OBSERVATIONAL STUDIES:

Meta-analyses and systematic reviews (in chronological order):

A Systematic Review of the Evidence Supporting a Causal Link Between Dietary Factors and Coronary Heart Disease” (review of observational data and clinical trials)

Archives of Internal Medicine (2009)

Andrew Mente, MA, PhD, Associate Professor, Department of Clinical Epidemiology & Biostatistics, McMaster University, Lawrence de Koning, Clinical Assistant Professor, Department of Pathology and Laboratory Medicine, Pediatrics, University of Calgary, et al.

Conclusions: “The evidence supports a valid association of a limited number of dietary factors and dietary patterns with CHD…. Insufficient evidence (< or =2 criteria) of association is present for intake of supplementary vitamin E and ascorbic acid (vitamin C); saturated and polyunsaturated fatty acids;…”

 

Meta-analysis of Prospective Cohort Studies Evaluating the Association of Saturated Fat with Cardiovascular Disease

American Journal of Clinical Nutrition (2010)

Siri-Tarino PW, Children’s Hospital, Oakland Research Institute Oakland, Sun Q, MD, Departments of Nutrition and Epidemiology, Harvard School of Public Health, Hu FB, MD, Departments of Nutrition and Epidemiology, Harvard School of Public Health, et al.

Conclusions: “A meta-analysis of prospective epidemiologic studies showed that there is no significant evidence for concluding that dietary saturated fat is associated with an increased risk of CHD or CVD. More data are needed to elucidate whether CVD risks are likely to be influenced by the specific nutrients used to replace saturated fat.”

 

Association of Dietary, Circulating, and Supplement Fatty Acids with Coronary Risk: A Systematic Review and Meta-analysis” (on observational data on all fatty acids and RCTs on supplementation with polyunsaturated fats, o3s or o6s)

Annals of Internal Medicine (2014)

Rajiv Chowdhury, MD, PhD, University of Cambridge, Samantha Warnakula, University of Cambridge, et al.

Details: RCT data reviewed is on 105,085 participants; observational data is on roughly 550,000 participants. The RCT analysis combined trials that increased either omega 3s or omega 6s.

Conclusion: “Current evidence does not clearly support cardiovascular guidelines that encourage high consumption of polyunsaturated fatty acids and low consumption of total saturated fats.”

 

“Intake of Saturated and Trans Unsaturated Fatty Acids and Risk of All Cause Mortality, Cardiovascular Disease, and Type 2 Diabetes: Systematic Review and Meta-Analysis of Observational Studies.” (on observational data)

The BMJ (Clinical Research ed.) (2015)

R.J. de Souza, Department of Clinical Epidemiology and Biostatistics, McMaster University, Chanchlani Research Centre, McMaster University, A. Mente, Population Health Research Institute, McMaster University, et al.

Conclusion: “Saturated fats are not associated with all cause mortality, CVD, CHD, ischemic stroke, or type 2 diabetes, but the evidence is heterogeneous with methodological limitations.”

 

Non-systematic reviews:

“Saturated Fats Versus Polyunsaturated Fats Versus Carbohydrates for Cardiovascular Disease Prevention and Treatment”

Annual Review of Nutrition (2015)

Patty W. Siri-Tarino, PhD, Sally Chiu, PhD, Nathalie Bergeron, PhD, and Ronald M. Krauss, PhD, Atherosclerosis Research Program, Children’s Hospital Oakland Research Institute, Oakland, California

Conclusions: “Replacement of SFAs with polyunsaturated fatty acids has been associated with reduced CVD risk, although there is heterogeneity in both fatty acid categories. In contrast, replacement of SFAs with carbohydrates, particularly sugar, has been associated with no improvement or even a worsening of CVD risk…

Replacement of SFAs with CHOs [carbohydrates] has not been associated with benefit and may be associated with increased CVD risk….The effects of various SFA replacement scenarios on CVD risk factors other than lipids and lipoproteins are ambiguous…

 

 

The PURE Study,: largest-ever epidemiological study, contradicts diet-heart hypothesis

Associations of fats and carbohydrate intake with cardiovascular disease and mortality in 18 countries from five continents (PURE): a prospective cohort study
The Lancet (2017)
Mahshid Dehghan, Andrew Mente, Xiaohe Zhang, et al., on behalf of the Prospective Urban Rural Epidemiology (PURE) study investigators*
Interpretation of findings: “High carbohydrate intake was associated with higher risk of total mortality, whereas total fat and individual types of fat were related to lower total mortality. Total fat and types of fat were not associated with cardiovascular disease, myocardial infarction, or cardiovascular disease mortality, whereas saturated fat had an inverse association with stroke. Global dietary guidelines should be reconsidered in light of these findings.”

 

This summary prepared by Nina Teicholz.

[1] The “diet-heart hypothesis,” proposed principally by Ancel Benjamin Keys, holds that saturated fats and dietary cholesterol cause heart disease. Authorities in the U.S., including the American Heart Association and the U.S. Dietary Guidelines for Americans, have recently dropped their caps on dietary cholesterol, exonerating it from Keys’ original claim. However these authorities continue their caps on saturated fats.