Veterans Admin 1969.

Study characteristics
Methods	RCT Summary risk of bias: moderate to high
Participants	Men living at the Veterans Administration Center (USA) CVD risk: low Control: randomised 422, analysed 422 Intervention: randomised 424, analysed 424 Mean years in trial: control 3.7, intervention 3.7 % male: 100 Age: mean control 65.6, intervention 65.4 (all 54 ‐ 88) Ethnicity: White 90%, African‐American 7%, Asian 1%, Mexican 1%, other 1% Statins use allowed? Unclear (only 4 participants were taking nicotinic acid, 17 diuretics, 56 digitalis, none on heparin) % taking statins: Not reported (probably none as too early, pre‐1980)
Interventions	Modified fat vs usual diet Control aims: provided, total fat 40%E Intervention aims: total fat 40%E, ⅔ of SFA replaced by unsaturated fats, dietary chol reduced Control methods: whole diet provided Intervention methods: whole diet provided Total fat intake, %E (during trial): int 38.9 (SD unclear), cont 40 (SD unclear) (mean difference ‐1.10, 95% CI ‐2.45 to 0.25 assuming SDs of 10) no significant difference Saturated fat intake, %E (during trial): int 8.3 (SD unclear), cont 18.5 (SD unclear) (mean difference ‐10.20, 95% CI ‐10.87 to ‐9.53 assuming SDs of 5) significant reduction PUFA intake, %E (during trial)§: int 16.0 (SD ?), cont 4.9 (SD 0.10) (mean difference 11.10, 95% CI 10.62 to 11.58 assuming missing SD was 5) significant increase PUFA n‐3 intake: not reported PUFA n‐6 intake: not reported MUFA intake, %E (during trial)⁑: not reported, approx int 14.0, cont 17.2 (mean difference ‐3.20, 95% CI ‐3.87 to ‐2.53) significant reduction CHO intake, %E (during trial)⁑: not reported, approx int 45.9, cont 44.8 (mean difference 1.10, 95% CI ‐1.60 to 3.80 assuming SDs of 20) no significant difference Protein intake, %E (during trial)§: int 15.2 (SD ?), cont 15.2 (SD ?) (mean difference 0.00, 95% CI ‐0.67 to 0.67 assuming SDs of 5) no significant difference Trans fat intake: not reported Replacement for saturated fat: mainly PUFA (based on dietary aims and achievements) Style: diet provided Setting: residential institution §Dayton 1965 ⁑Estimated by subtraction (assuming total fat = SFA + PUFA + MUFA or energy intake = energy from fat + CHO + protein)
Outcomes	Stated trial outcomes: mortality, heart disease Data available on total mortality? yes Cardiovascular mortality? yes Events available for combined cardiovascular events: sudden death, definite MI, definite stroke, angina, PVD events Secondary outcomes: cancer deaths, cancer diagnoses, stroke, non‐fatal MI, total MI, CHD deaths (fatal MI and sudden death due to CHD), CHD events (any MI or sudden death due to CHD) Tertiary outcomes: none (some data on total cholesterol, but no variance info)
Notes	Study duration over 8 years Study aim was to replace 66% of saturated fat by unsaturated fats, and saturated fat intake in the intervention group was significantly lower than in control SFA reduction aimed and achieved Total serum cholesterol, difference between intervention and control, mmol/L: ‐0.37 (95% CI ‐0.77 to 0.03), NO statistically significant reduction but reduction > 0.20 Trial dates: Recruitment 1959 to 1967 Funding: Veterans Administration, Arthur Dodd Fuller Foundation, National Heart Institute, Los Angeles County Heart Association, plus gifts of foods from Mazola corn oil and Mazola margarine, the National Soybean Processors Association, Pitman‐Moore Company (Emdee margarine) and Hi‐Saff Imitation Ice‐cream from Frozen Desserts Company. Edgmar Farms donated milk refrigeration equipment. Declarations of Interest of primary researchers: none stated, all authors worked for academic or health institutions.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "table of random numbers used"
Allocation concealment (selection bias)	Low risk	Extensive baseline assessment before randomisation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Institution provided diet in a masked fashion.
Blinding of outcome assessment (detection bias) CVD outcomes	Low risk	Physician knowledge of allocation was assessed and found similar to random.
Blinding of outcome assessment (detection bias) All‐cause mortality	Low risk	Blinding is not relevant in assessment of mortality.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All followed up via Veterans Admin system
Selective reporting (reporting bias)	Low risk	Not relevant for primary and secondary outcomes as all trialists were asked for data
Free of systematic difference in care?	Low risk	All ate centre food as usual. See control and intervention methods in the Interventions section of the table of Characteristics of included studies
Stated aim to reduce SFA	Low risk	Aim to reduce SFA stated
Achieved SFA reduction	Low risk	SFA reduction achieved
Achieved TC reduction	High risk	No statistically significant TC fall, though fall was > 0.20 mmol/L
Other bias	Low risk	None noted