Study | Population | Dietary Intervention | Duration | Cholesterol reduction | Mortality benefit? | CVE benefit? | Comments |
Ball, 1965 Research Committee | 264 men<65 years s/p MI | Reduce total fat to 40 g/d | 3 years | TC −7%* | No (RR 0.87, 95% CI 0.51 to 1.50) | No (RR 1.01, 95% CI 0.73 to 1.38) | CVE=CHD death or mi |
Rose, 1965 | 54 subjects<70 years, CHD | Corn oil 80 g/d | 2 years | TC −0.58 mmol/L | No (RR 5.31, 95% CI 0.32 to 89.44) | No (RR 1.16, 95% CI 0.59 to 2.29) | Small population Cholesterol reduction NS |
Rose, 1965 | 52 subjects<70 years, CHD | Olive oil 80 g/d | 2 years | TC unchanged | No (RR 1.50, 95% CI 0.17 to 13.05) | No (RR 1.10, 95% CI 0.48 to 2.50) | Small population |
Leren, 1966 Oslo Diet Heart | 412 men s/p MI | Reduced animal fat and cholesterol, replaced with vegetable oil | 4.3 years | TC −1.07 mmol/L* | No (RR 0.82, 95% CI 0.54 to 1.26) | Yes (RR 0.71, 95% CI 0.55 to 0.92) | |
Morris, 1968 Medical Research Council | 393 men s/p MI | Replace saturated fat with three ounces soy bean oil/d | 4 years | TC −0.64 mmol/L* | No (RR 0.88, 95% CI 0.55 to 1.41) | No (RR 0.82, 95% CI 0.62 to 1.07) | |
Dayton, 1969 Los Angeles VA | 883 men | Replace SFA with mainly PUFA | 8 years | TC −0.37 mmol/L | No (RR 0.98, 95% CI 0.83 to 1.15) | No (RR 0.79, 95% CI 0.94 to 1.0) | Cholesterol reduction NS |
Miettinen, et al,
6 1972 Finnish Mental Hospital | 10 612 patients with psychological illness | Replace SFA with PUFA | 6–12 years | TC −14%* | Yes (RR 0.71, 95% CI 0.64 to 0.79) | Not reported | Not truly randomised (cluster randomised) |
Houtsmuller, 1979 | 102 DM retinopathy | Replace SFA with mainly PUFA | 6 years | TC –0.47 mmol/L* | Not reported | Yes (RR 0.27, 95% CI 0.14 to 0.52) | Small population |
Hjermann, 1981 Oslo Cardiovascular Study | 1232 high-risk men | Smoking cessation+replace SFA with PUFA | 5 years | Not reported | No (RR 0.69, 95% CI 0.37 to 1.29) | Yes (RR 0.57, 95% CI 0.35 to 0.93) | Multiple simultaneous interventions Cholesterol not reported |
Burr et al,
11 1989 DART | 2033 men <70 years s/p MI | Replace SFA with PUFA, carbohydrate and protein | 2 years | TC −0.26 mmol/L* | No (RR 1.0, 95% CI 0.77 to 1.30) | No (RR 0.91, 95% CI 0.72 to 1.16) | |
Burr et al,
11 1989 DART-fish | 2033 men <70 years s/p MI | Fish two times/week | 2 years | TC unchanged | Yes (RR 0.71, 95% CI 0.54 to 0.93) | No (RR 0.84, 95% CI 0.66 to 1.07) | |
Burr et al,
11 1989 DART-fibre | 2033 men <70 years s/p MI | Fibre 18 g/day | 2 years | TC unchanged | No (RR 1.27, 95% CI 0.99 to 1.65) | No (RR 1.23, 95% CI 0.97 to 1.57) | |
Watts, 1992 STARS | 50 men s/p MI | Reduced fat, replaced with PUFA, high fibre | 2 years | TC −14%* LDL −16%* | No (RR 0.35, 95% CI 0.04 to 3.12) | No (RR 0.31, 95% CI 0.10 to 1.01) | Small population |
Watts, 1992 STARS | 48 men s/p MI | Reduced fat, replaced with PUFA, high fibre+cholestyramine | 2 years | TC −25%* LDL −36%* | No (RR 0.15, 95% CI 0.01 to 2.83)* | Yes (RR 0.11, 95% CI 0.01 to 0.78)* | Small population Drug+diet used to lower cholesterol |
Black, 1994 | 133 non-melanoma skin cancer | Replace SFA with carbohydrate and protein | 2 years | Not reported | No (RR 0.51, 95% CI 0.05 to 5.46) | No (RR 0.20, 95% CI 0.01 to 4.15) | Small population Cholesterol not reported |
de Lorgeril et al,
10 1999 Lyon Diet Heart Study | 605 s/p MI | Mediterranean diet | 5 years | TC unchanged | Yes (RR 0.44, 95% CI 0.21 to 0.94) | Yes (RR 0.28, 95% CI 0.15 to 0.53) | |
Moy, 2001 | 327 siblings of patients with CHD | Nurse supervised reduced total fat, replacement unclear | 2 years | LDL −0.29 mmol/L* | Not reported | No (RR 1.68, 95% CI 0.41 to 6.87) | |
Burr et al,
8 2003 DART-2-fish | 1528 men angina <70 years | ≥2 fish portions/week and/or fish oil 3 g/d | 3–9 years | Not reported | No (RR 1.29, 95% CI 1.03 to 1.63) | Not reported | Cholesterol not reported Increased mortality among fish oil users Trial interrupted for 1 year |
Burr et al,
8 2003 DART-2-vegetable | 1543 men angina <70 years | 4–5 portions fruits+vegetables/d+OJ + >8 g/d of soluble fibre | 3–9 years | Not reported | No (RR 1.20, 95% CI 0.95 to 1.51) | Not reported | Cholesterol not reported Trial interrupted for 1 year |
Burr et al,
8 2003 DART-2-fish+vegetable | 1571 men angina <70 years | Both fish and fruits/vegetables as above | 3–9 years | Not reported | No (RR 1.23, 95% CI 0.98 to 1.55) | Not reported | Cholesterol not reported Trial interrupted for 1 year |
Ley, 2004 | 176 glucose intolerant | Replace SFA with carbohydrate and protein | 5 years | TC −0.05 mmol/L | No (RR 0.33, 95% CI 0.67 to 1.61) | No (RR 0.69, 95% CI 0.34 to 1.40) | Cholesterol reduction NS |
Howard, 2006 WHI | 48 835 post-menopausal women, 50–79 years | Reduced total fat, replaced with increased fruits, vegetables, grains | 8.1 years | TC −3.26 mg/dL* LDL –3.55 mg/dL* | No (HR 1.02, 95% CI 0.84 to 1.25) | No (HR 0.98, 95% CI 0.88 to 1.09) | |
Chlebowski, 2006 WINS | 2437 women with breast cancer | Reduced SFA replaced with carbohydrate and protein | 5 years | TC –0.14 mmol/L | No (RR 1.18, 95% CI 0.60 to 2.32) | Not reported | Cholesterol reduction NS |
Tuttle, 2008 THIS-DIET | 101 s/p first MI | Low fat Mediterranean diet (>0.75% of calories from omega-3) versus low fat | 2 years | LDL −3 mg/dL | No (RR 0.98, 95% CI 0.02 to 48.50) | No (RR 0.98, 95% CI 0.40 to 2.41) | Small population Both groups counselled low fat+low cholesterol Cholesterol reduction NS |
Ramsden, 2013 Sydney Diet Heart Study | 458 men recent coronary event, 30–59 years | Replace SFA with omega-6 linoleic acid (safflower oil) | 3.25 years | TC −8%* | No (HR 1.62, 95% CI 1.0 to 2.64) | No (HR 1.7, 95% CI 1.03 to 2.8) | Increased CVE and mortality with intervention |
Brancati, 2013 Look-AHEAD | 5145 obese T2DM | Reduced calories and increased exercise versus DM support+education | 9.6 years | LDL –1.2 mg/dL in control group* | No (HR 0.85, 95% CI 0.69 to 1.04) | No (HR 0.95, 95% CI 0.83 to 1.09) | Multiple simultaneous interventions |
Ramsden, 2016 Minnesota Coronary Experiment | 9423 institutionalised | Replace SFA with linoleic acid (corn oil) | >1 year (2355 subjects) | TC −13%* | No (HR 1.22, 95% CI 1.14 to 1.32) | Not reported | Many patients lost to follow-up Increased mortality with intervention |
Estruch et al,
9 2018 PREDIMED | 7447 subjects | Mediterranean diet | 4.8 years | Not reported | No (RR 0.89, 95% CI 0.71 to 1.12) | Yes (RR 0.70, 95% CI 0.55 to 0.89) | Article retracted and republished Cholesterol not reported |
*Statistically significant p<0.05.
CHD, coronary heart disease; CVE, cardiovascular event; DM, diabetes mellitus; LDL, low-density lipoprotein-cholesterol; MI, myocardial infarction; NS, not significant; OJ, orange juice; PUFA, polyunsaturated fatty acid; RR, risk ratio; s/p, status post; SFA, saturated fatty acid; T2DM, type 2 diabetes mellitus; TC, total cholesterol; VA, Veterans Administration.