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. 2020 May 19;2020(5):CD011737. doi: 10.1002/14651858.CD011737.pub2
Study Reason for exclusion
Agewall 2001 Multifactorial intervention
Ammerman 2003 No appropriate control group (and not low fat vs modified fat)
Anderson 1990 Follow‐up less than 24 months
Aquilani 2000 No appropriate control group (and not low fat vs modified fat)
Arntzenius 1985 No appropriate control group (and not low fat vs modified fat)
Aro 1990 Intervention and randomised follow‐up less than 6 months
ASSIST 2001 Intervention was not dietary fat modification or low fat diet.
Australian Polyp Prev 95 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Azadbakht 2007 Follow‐up less than 24 months
Bakx 1997 Multifactorial intervention
Ball 1965 Study aim was to assess effects of a low‐fat diet and methods stated that the "nature of the fat consumed was not altered". Saturated fat content of diet was not reported.
Barnard 2009 Weight reduction encouraged in the conventional diet, but not in the vegan diet arm
Barndt 1977 No appropriate control group (and not low fat vs modified fat)
Baron 1990 Multifactorial intervention
Barr 1990 Intervention and randomised follow‐up less than 6 months
Barsotti 1991 Complex paper in Italian; unclear whether cardiovascular events occurred; contact with authors not established
Baumann 1982 Intervention and randomised follow‐up less than 6 months
BDIT Pilot Studies 1996 Study aim was to reduce total fat intake to 15%E with no specific intervention on saturated fat. Saturated fat in intervention group was more than 80% of that in the control group.
Beckmann 1995 Intervention was not dietary fat modification or low‐fat diet.
beFIT 1997 Follow‐up less than 24 months
Beresford 1992 Intervention and randomised follow‐up less than 6 months
Bergstrom 1967 Intervention and randomised follow‐up less than 6 months
Bierenbaum 1963 No appropriate control group (and not low fat vs modified fat)
Bloemberg 1991 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Bloomgarden 1987 Multifactorial intervention
Bonk 1975 Trial, unclear if randomised; contact could not be established with trialists
Bonnema 1995 No appropriate control group (and not low fat vs modified fat)
Bosaeus 1992 Intervention and randomised follow‐up less than 6 months
Boyd 1988 Follow‐up less than 24 months
BREACPNT Individual microbiome‐based dietary advice vs Mediterranean diet (no suggestion of saturated fat reduction in either arm)
Brehm 2009 Unclear whether any relevant events occurred, not able to contact trialists
Brensike 1982 No appropriate control group (and not low fat vs modified fat)
BRIDGES 2001 Follow‐up less than 24 months
Broekmans 2003 Intervention was not dietary fat modification or low fat diet.
Brown 1984 No appropriate control group (and not low fat vs modified fat)
Bruce 1994 No appropriate control group (and not low fat vs modified fat)
Bruno 1983 Multifactorial intervention
Butcher 1990 Intervention and randomised follow‐up less than 6 months
Byers 1995 No appropriate control group (and not low fat vs modified fat)
Caggiula 1996 No appropriate control group (and not low fat vs modified fat)
Canadian DBCP 1997 Unable to establish contact with authors to provide data on numbers of deaths and CV events
CARMEN 2000 Follow‐up less than 24 months
CARMEN substudy 2002 Follow‐up less than 24 months
Casas‐Agustench 2013 Less than 24 months duration
Cerin 1993 Intervention and randomised follow‐up less than 6 months
Chan 1993 Intervention and randomised follow‐up less than 6 months
Chapman 1950 Intervention and randomised follow‐up less than 6 months
Charbonnier 1975 Intervention and randomised follow‐up less than 6 months
Cheng 2004 Intervention and randomised follow‐up less than 6 months
Chiostri 1988 Intervention and randomised follow‐up less than 6 months
Choudhury 1984 Intervention and randomised follow‐up less than 6 months
Clark 1997 Multifactorial intervention
Clifton 1992 Intervention and randomised follow‐up less than 6 months
Cobb 1991 Intervention and randomised follow‐up less than 6 months
Cohen 1991 Intervention was not dietary fat modification or low fat diet.
Cole 1988 Intervention and randomised follow‐up less than 6 months
Colquhoun 1990 Intervention and randomised follow‐up less than 6 months
Consolazio 1946 Intervention and randomised follow‐up less than 6 months
Cox 1996 Multifactorial intervention
Croft 1986 Intervention was not dietary fat modification or low fat diet.
Curzio 1989 Follow‐up less than 24 months
Da Qing IGT 1997 Intervention was not dietary fat modification or low‐fat diet.
Dalgard 2001 No appropriate control group (and not low fat vs modified fat)
DAS 2000 No appropriate control group (and not low fat vs modified fat)
DASH 1997 Intervention and randomised follow‐up less than 6 months
Davey Smith 2005 Multifactorial intervention
De Boer 1983 Intervention and randomised follow‐up less than 6 months
De Bont 1981 Neither mortality nor cardiovascular morbidity data available as study data have been lost
DeBusk 1994 Multifactorial intervention
DEER 1998 Duration 1 year only
Delahanty 2001 No appropriate control group (and not low fat vs modified fat)
Delius 1969 Intervention was not dietary fat modification or low fat diet.
Demark 1990 Intervention and randomised follow‐up less than 6 months
Dengel 1995 No appropriate control group (and not low fat vs modified fat)
Denke 1994 Intervention and randomised follow‐up less than 6 months
Diabetes CCT 1995 Intervention was not dietary fat modification or low fat diet.
Diet & Hormone Study 2003 Duration 1 year only
DIET 1998 Multifactorial intervention
Ding 1992 Intervention and randomised follow‐up less than 6 months
DIPI 2018 Less than 24 months duration
DIRECT 2009 Unable to establish contact with authors to establish whether relevant events occurred; multiple publications checked and no relevant outcomes found
DO IT 2006 Intervention aim was for a "mediterranean diet" with total fat 27 ‐ 30%E, protein 15 ‐ 18%E, CHO 50 ‐ 55%E, no specific aim to reduce saturated fat (though polyunsaturated margarine given to intervention group), and intervention group saturated fat was more than 80% of that in the control.
Dobs 1991 No appropriate control group (and not low fat vs modified fat)
Due 2008 Follow‐up less than 24 months
Duffield 1982 Multifactorial intervention
Dullaart 1992 Study authors confirmed that no deaths or cardiovascular events occurred during the study.
Eating Patterns 1997 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Ehnholm 1982 Intervention and randomised follow‐up less than 6 months
Ehnholm 1984 Intervention and randomised follow‐up less than 6 months
Eisenberg 1990 Intervention and randomised follow‐up less than 6 months
Elder 2000 No appropriate control group (and not low fat vs modified fat)
Ellegard 1991 Intervention and randomised follow‐up less than 6 months
Esposito 2003 No appropriate control group (and not low fat vs modified fat)
Esposito 2004 Unable to establish contact with authors to assess whether any relevant events occurred
EUROACTION 2008 Multifactorial intervention
FARIS 1997 Multifactorial intervention
Fasting HGS 1997 No appropriate control group (and not low fat vs modified fat)
Ferrara 2000 No appropriate control group (and not low fat vs modified fat)
Fielding 1995 Intervention and randomised follow‐up less than 6 months
Finnish Diabet Prev 2000 Multifactorial intervention
Finnish Mental Hosp 1972 Not randomised (cluster‐randomised, but < 6 clusters)
Fisher 1981 Intervention and randomised follow‐up less than 6 months
FIT Heart 2011 Authors confirmed that differences between intervention and control groups included smoking and physical activity, as well as dietary changes.
Fleming 2002 No appropriate control group (and not low fat vs modified fat)
Fortmann 1988 Intervention was not dietary fat modification or low fat diet.
Foster 2003 Weight reduction in 1 arm but not the other
Frenkiel 1986 Follow‐up less than 24 months
FRESH START 2007 Participants were newly diagnosed with cancer.
Gambera 1995 Intervention and randomised follow‐up less than 6 months
Gaullier 2007 No appropriate control group (and not low fat vs modified fat)
Ginsberg 1988 Intervention and randomised follow‐up less than 6 months
Gjone 1972 Intervention and randomised follow‐up less than 6 months
Glatzel 1966 No appropriate control group (and not low fat vs modified fat)
Goodpaster 1999 No appropriate control group (and not low fat vs modified fat)
Grundy 1986 Intervention and randomised follow‐up less than 6 months
Hardcastle 2008 Multifactorial intervention
Harris 1990 Intervention and randomised follow‐up less than 6 months
Hartman 1993 No appropriate control group (and not low fat vs modified fat)
Hartwell 1986 No appropriate control group (and not low fat vs modified fat)
Hashim 1960 Intervention and randomised follow‐up less than 6 months
Haufe 2011 Aim was to reduce total fat or reduce carbohydrate, but no saturated fat aims were stated, and effects of the diets on saturated fat intakes were unclear.
Haynes 1984 Intervention was not dietary fat modification or low fat diet.
Heber 1991 Intervention and randomised follow‐up less than 6 months
Heine 1989 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Hellenius 1995 The study aimed for weight loss in 1 arm and not in the comparison arm.
Heller 1993 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Hildreth 1951 No appropriate control group (and not low fat vs modified fat)
Holm 1990 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Horlick 1957 Intervention and randomised follow‐up less than 6 months
Horlick 1960 Intervention and randomised follow‐up less than 6 months
Howard 1977 Intervention and randomised follow‐up less than 6 months
Hunninghake 1990 Intervention and randomised follow‐up less than 6 months
Hutchison 1983 No appropriate control group (and not low fat vs modified fat)
Hyman 1998 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Iacono 1981 Not randomised; Intervention and randomised follow‐up less than 6 months
IMPACT 1995 Multifactorial intervention
Iso 1991 No appropriate control group (and not low fat vs modified fat)
Ives 1993 Multifactorial intervention
Jalkanen 1991 Multifactorial intervention
Jerusalem Nut 1992 Intervention and randomised follow‐up less than 6 months
Jula 1990 Multifactorial intervention
Junker 2001 Intervention and randomised follow‐up less than 6 months
Karmally 1990 Intervention and randomised follow‐up less than 6 months
Karvetti 1992 Multifactorial intervention
Kastarinen 2002 Multifactorial intervention
Kather 1985 Intervention and randomised follow‐up less than 6 months
Katzel 1995 Intervention was not dietary fat modification or low fat diet.
Kawamura 1993 Intervention and randomised follow‐up less than 6 months
Keidar 1988 Intervention and randomised follow‐up less than 6 months
Kempner 1948 No appropriate control group (and not low fat vs modified fat)
Keys 1957a Intervention and randomised follow‐up less than 6 months
Keys 1957b Intervention and randomised follow‐up less than 6 months
Keys 1957c Intervention and randomised follow‐up less than 6 months
Khan 2003 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
King 2000 Intervention and randomised follow‐up less than 6 months
Kingsbury 1961 Intervention and randomised follow‐up less than 6 months
KNOTA Numerous publications checked, but no relevant outcome data found. Trialists not contacted.
Koopman 1990 Intervention and randomised follow‐up less than 6 months
Koranyi 1963 Unclear whether randomised, unable to contact authors to discuss
Korhonen 2003 Multifactorial intervention
Kriketos 2001 Intervention and randomised follow‐up less than 6 months
Kris 1994 Intervention and randomised follow‐up less than 6 months
Kristal 1997 Multifactorial intervention
Kromhout 1987 No appropriate control group (and not low fat vs modified fat)
Kummel 2008 Intervention was not dietary fat modification or low‐fat diet.
Laitinen 1993 Multifactorial intervention
Laitinen 1994 Multifactorial intervention
Lean 1997 Follow‐up less than 24 months
Leduc 1994 Multifactorial intervention
Lewis 1958 Intervention and randomised follow‐up less than 6 months
Lewis 1981 Intervention and randomised follow‐up less than 6 months
Lewis 1985 Multifactorial intervention
Lichtenstein 2002 Intervention and randomised follow‐up less than 6 months
Lim 2010 Unable to establish contact with authors to gain access to data on health outcomes (none reported in paper)
Linko 1957 Intervention and randomised follow‐up less than 6 months
Lipid Res Clinic 1984 No appropriate control group (and not low fat vs modified fat)
Little 1990 Intervention and randomised follow‐up less than 6 months
Little 2004 Intervention was not dietary fat modification or low‐fat diet.
Lottenberg 1996 Intervention and randomised follow‐up less than 6 months
Luszczynska 2007 No appropriate control group (and not low fat vs modified fat)
Lyon Diet Heart 1994 Intervention was not dietary fat modification or low‐fat diet.
Lysikova 2003 Intervention and randomised follow‐up less than 6 months
Macdonald 1972 Intervention and randomised follow‐up less than 6 months
Mansel 1990 Intervention was not dietary fat modification or low‐fat diet
MARGARIN 2002 No appropriate control group (and not low fat vs modified fat)
Marniemi 1990 Both intervention groups aimed to lose weight, while the control group did not.
Mattson 1985 Intervention and randomised follow‐up less than 6 months
McAuley 2005 Follow‐up less than 24 months
McCarron 1997 Intervention and randomised follow‐up less than 6 months
McCarron 2001 Intervention was not dietary fat modification or low‐fat diet.
McKeown‐Eyssen 1994 Intervention aim was to reduce total fat and increase dietary fibre (saturated fat not mentioned), and no saturated fat intakes during trial reported.
McManus 2001 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
McNamara 1981 Intervention and randomised follow‐up less than 6 months
Medi‐RIVAGE 2004 Weight reduction for some low‐fat diet participants (those with BMI > 25) but not in Mediterranean group
MeDiet 2002 Follow‐up less than 24 months
MEDINA Less than 24 months duration
Mensink 1987 Intervention and randomised follow‐up less than 6 months
Mensink 1989 Intervention and randomised follow‐up less than 6 months
Mensink 1990a Intervention and randomised follow‐up less than 6 months
Mensink 1990b Intervention and randomised follow‐up less than 6 months
Metroville Health 2003 Unable to establish contact with authors to assess whether any relevant events occurred
Michalsen 2006 Diet plus stress management vs no intervention
Miettinen 1994 Intervention and randomised follow‐up less than 6 months
Millar 1973 No appropriate control group (and not low fat vs modified fat)
Miller 1998 Intervention and randomised follow‐up less than 6 months
Miller 2001 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Milne 1994 No appropriate control group (and not low fat vs modified fat) ‐ the high CHO diet was neither 'usual' or 'low fat' to compare with the modified fat diet.
Minnesota Coronary 1989 Although the study proceeded for over 4 years, participants (patients) came and went and mean follow‐up was only 1 year.
Minnesota HHP 1990 No appropriate control group (and not low fat vs modified fat)
Mojonnier 1980 Unable to establish contact with authors to assess whether any relevant events occurred
Mokuno 1988 Intervention and randomised follow‐up less than 6 months
Mortensen 1983 Intervention and randomised follow‐up less than 6 months
Mottalib 2018 Less than 24 months duration
MRFIT substudy 1986 Intervention and randomised follow‐up less than 6 months
MSDELTA 1995 Intervention and randomised follow‐up less than 6 months
MSFAT 1997 Follow‐up less than 24 months
Mujeres Felices 2003 Diet and breast self‐examination vs no intervention
Mutanen 1997 Intervention and randomised follow‐up less than 6 months
Muzio 2007 Intervention and randomised follow‐up less than 6 months
Naglak 2000 Unable to establish contact with authors to assess whether any relevant events occurred
NAS 1987 Intervention and randomised follow‐up less than 6 months
National Diet Heart 1968 Follow‐up less than 24 months
NCEP weight 1991 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
NCT01954472 Study withdrawn (not completed)
NCT03068078 Less than 24 months duration
Neil 1995 No appropriate control group (and not low fat vs modified fat)
Neverov 1997 Multifactorial intervention
Next Step 1995 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Nordoy 1971 Intervention and randomised follow‐up less than 6 months
Norway Veg Oil 1968 No appropriate control group (and not low fat vs modified fat)
Nutri‐AGEs 2015 Less than 24 months duration
Nutrition Breast Health Follow‐up less than 24 months
O'Brien 1976 Intervention and randomised follow‐up less than 6 months
ODES 2006 The study aimed for weight loss in 1 arm and not in the other arm.
Oldroyd 2001 Multifactorial intervention
Ole Study 2002 Follow‐up less than 24 months
OLIVE 1997 Unable to establish contact with authors to assess whether any relevant events occurred
ORIGIN 2008 Intervention was not dietary fat modification or low‐fat diet.
Oslo Study 2004 Multifactorial intervention
Pascale 1995 Multifactorial intervention
PEP 2001 Multifactorial intervention
PHYLLIS 1993 No appropriate control group (and not low fat vs modified fat)
Pilkington 1960 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Polyp Prevention 1996 Intervention aim was to reduce total fat and increase dietary fibre, fruit and vegetables (saturated fat not mentioned), and no saturated fat intakes during trial reported.
POUNDS LOST 2009 All study arms (low or high total fat) prescribed low saturated fat intake (8%E); no usual fat comparator.
PREDIMED 2008 Total fat goals in the low‐fat arm were unclear and authors confirmed that aims were nonspecific (if aims < 30%E, this study would be included).
PREMIER 2003 Follow‐up less than 24 months
Pritchard 2002 The study aimed for weight loss in 1 arm and not in the comparison arm.
Puget Sound EP 2000 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Rabast 1979 Intervention and randomised follow‐up less than 6 months
Rabkin 1981 Intervention and randomised follow‐up less than 6 months
Radack 1990 Intervention and randomised follow‐up less than 6 months
Rasmussen 1995 Intervention and randomised follow‐up less than 6 months
Reaven 2001 Intervention and randomised follow‐up less than 6 months
Reid 2002 No appropriate control group (and not low fat vs modified fat)
Renaud 1986 Not randomised
Rivellese 1994 Follow‐up less than 24 months
Rivellese 2003 Intervention and randomised follow‐up less than 6 months
Roderick 1997 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Roman CHD prev 1986 Multifactorial intervention
Rose 1987 No appropriate control group (and not low fat vs modified fat)
Sarkkinen 1995 Follow‐up less than 24 months
Schaefer 1995a Intervention and randomised follow‐up less than 6 months
Schaefer 1995b Intervention and randomised follow‐up less than 6 months
Schectman 1996 Multifactorial intervention
Schlierf 1995 Multifactorial intervention
Seppanen‐Laakso 1992 Intervention and randomised follow‐up less than 6 months
Seppelt 1996 Follow‐up less than 24 months
Singh 1991 Multifactorial intervention
Singh 1992 No appropriate control group (and not low fat vs modified fat)
Sirtori 1992 Intervention and randomised follow‐up less than 6 months
SLIM 2008 Multifactorial intervention
Sopotsinskaia 1992 The study aimed for weight loss in 1 arm and not in the comparison arm.
Soul Food Light Less than 24 months duration
Stanford NAP 1997 Intervention and randomised follow‐up less than 6 months
Stanford Weight 1994 The study aimed for weight loss in 1 arm and not in the comparison arm.
Starmans 1995 Intervention and randomised follow‐up less than 6 months
Steinbach 1996 Multifactorial intervention
Steptoe 2001 No appropriate control group (and not low fat vs modified fat)
Stevens 2002 Diet plus breast self examination vs no intervention
Stevenson 1988 No appropriate control group (and not low fat vs modified fat)
Strychar 2009 Follow‐up less than 24 months
Sweeney 2004 Intervention was not dietary fat modification or low fat diet.
Søndergaard 2003 Follow‐up less than 24 months
TAIM 1992 Intervention was not dietary fat modification or low fat diet.
Tapsell 2004 Unable to establish contact with authors to assess whether any relevant events occurred
THIS DIET 2008 All study arms prescribed low saturated fat intake, no usual fat comparator
TOHP I 1992 Multifactorial intervention
TONE 1997 Intervention was not dietary fat modification or low‐fat diet.
Toobert 2003 Multifactorial intervention
Towle 1994 Intervention and randomised follow‐up less than 6 months
TRANSFACT 2006 Intervention and randomised follow‐up less than 6 months
Treatwell 1992 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Tromsø Heart 1989 Multifactorial intervention
Troyer 2010 Longest duration only 12 months
UK PDS 1996 No appropriate control group (and not low fat vs modified fat)
Urbach 1952 No appropriate control group (and not low fat vs modified fat)
Uusitupa 1993 Multifactorial intervention
VASTKOST 2012 Publications reported than no participants died or experienced CVD during the trial.
Vavrikova 1958 Intervention and randomised follow‐up less than 6 months
Verheiden 2003 Unable to establish contact with authors to assess whether any relevant events occurred
WAHA 2016 15%E from walnuts vs usual diet (neither arm aimed to reduce saturated fat intake)
Wass 1981 Intervention and randomised follow‐up less than 6 months
Wassertheil 1985 Intervention was not dietary fat modification or low fat diet.
WATCH 1999 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Watts 1988 Intervention and randomised follow‐up less than 6 months
Weintraub 1992 No appropriate control group (and not low fat vs modified fat)
Westman 2006 Intervention was not dietary fat modification or low fat diet.
Weststrate 1998 Intervention and randomised follow‐up less than 6 months
WHEL 2007 Study aimed to reduce total fat, but saturated fat goals were not mentioned, and saturated fat intake in the intervention group was more than 80% of that in the control (81%).
WHO primary prev 1979 Multifactorial intervention
WHT 1990 Neither mortality nor cardiovascular morbidity data available as such data were not collected in the study
WHT Feasibility 2003 Neither mortality nor cardiovascular morbidity data available (only decided after contact with at least 1 author)
Wilke 1974 Intervention and randomised follow‐up less than 6 months
Williams 1990 Intervention was not dietary fat modification or low‐fat diet.
Williams 1992 Intervention was not dietary fat modification or low‐fat diet.
Williams 1994 Intervention was not dietary fat modification or low‐fat diet.
Wilmot 1952 No appropriate control group (and not low fat vs modified fat)
Wing 1998 No appropriate control group (and not low fat vs modified fat)
WINS UK 2011 Stated aim was to reduce total fat by 50%; no saturated fat aims
WOMAN 2007 Lifestyle intervention included exercise and weight as well as diet.
Wood 1988 Intervention was not dietary fat modification or low‐fat diet.
Woollard 2003 Multifactorial intervention including smoking, weight, exercise and alcohol components
Working Well 1996 Multifactorial intervention
Zock 1995 Intervention and randomised follow‐up less than 6 months

CHO: carbohydrate
CV: cardiovascular 
E: energy
vs: versus