Characteristics of included randomised controlled trials in adults
| Trial | Participants | Intervention* | Control* | Duration (years)†, country |
|---|---|---|---|---|
| Aukland reduced fat (Ley 2004)16 | 176 adults with impaired glucose tolerance | Reduced fat diet (no specific goal) | Usual diet | 4.1, New Zealand |
| BDIT pilot studies (Boyd 1996)17 | 295 women with dysplasia on mammography | Total fat 15%, replace fat by complex carbohydrates | Healthy diet (no advice on fat) | 6.8 intervention, 7.5 control, Canada |
| beFIT 199718-20 | 409 people with mild hypercholesterolaemia | Total fat <30%, saturated fat <7%, dietary cholesterol <200 mg/day | Delayed dietary changes | Unclear (maximum 0.5), USA |
| Bloemberg 199121 | 80 men with untreated raised total cholesterol levels | Total fat 30%, polyunsaturated fat to saturated fat ratio 1.0, dietary cholesterol 20 mg/MJ | Usual diet | 0.5, Netherlands |
| BRIDGES (Hebert 2001)22 | 106 women with recent stage I or II breast cancer | Total fat 20%, high fibre, plant based | No formal intervention | Unclear (1 maximum), USA |
| Canadian diet and breast cancer prevention (Boyd 1997)23 | ≥896 women with mammographic densities >50% | Total fat 15%, protein 20%, carbohydrates 65%, isocaloric | Usual diet | 2.0, Canada |
| CARMEN 200024 25 | 153 healthy people, body mass index 26-34 | Fat reduced by 10%, increased simple/complex carbohydrates | Attain national “normal” intake | Unclear (maximum 0.5), Europe |
| CARMEN (metabolic syndrome substudy) 200224 | 22 people with at least three risk factors for metabolic syndrome | As for CARMEN study | As for CARMEN study | 0.5 intervention, 0.4 control, as for CARMEN study |
| De Bont 198126 | 148 women with type 2 diabetes | Fat 30%, reducing intake of meat fat and dairy foods, improving saturated fat to polyunsaturated fat ratio, increasing intake of carbohydrates | Usual diet with carbohydrates ≤40% | 0.5, UK |
| DEER (Stefanick 1998)27 | 197 men and 180 postmenopausal women with raised low density lipoprotein and reduced high density lipoprotein cholesterol levels | National cholesterol education programme step 2 diet: fat <30%, saturated fat <7%, <200 mg/day dietary cholesterol | Usual diet | 1.0, USA |
| German fat reduced (Seppelt 1996)28 | 70 women with body mass index 24-29 | Buy low fat foods from trial shop | Buy usual fat foods from trial shop | 0.8 intervention, 0.7 control, Germany |
| Kentucky low fat (Anderson 1990)29 30 | 118 moderately hypercholesterolaemic, non-obese white people | Fats 25%, protein 20%, carbohydrates 55%, dietary cholesterol <200 mg/day | No diet intervention | 0.9, USA |
| Sarkkinen 199331 | 159 community dwelling people with serum total cholesterol levels 6.5-8.0 mmol/L | American Heart Association diet: total fat 30%, saturated fat <10%, monounsaturated fat 10%, polyunsaturated fat 10%. Low fat diet: total fat 28-30%, saturated fat <14%, monounsaturated fat 10%, polyunsaturated fat 4% | Monounsaturated fat diet: fat 38%, saturated fat <14%, monounsaturated fat 18%, polyunsaturated fat <6%. Control diet: fat 38%, saturated fat <18%, monounsaturated fat 15%, polyunsaturated fat <5% | 0.5, Finland |
| Mastopathy diet (Boyd 1988)32 | 21 women with severe cyclical mastopathy | Total fat 15%, carbohydrates 65% | Healthy diet, no advice on fat | 0.45, Canada |
| MeDiet (Castagnetta 2006)33 | 115 healthy postmenopausal women with high testosterone levels | Sicilian diet (reduced intake of total, saturated, and omega 6 fats, increased intake of fish, whole cereals, legumes, seeds, fruit, and vegetables) | Increase fruit and vegetable intake | 4.3, Italy |
| Moy 200134 | 267 siblings of people with early coronary heart disease, with one or more risk factors for cardiovascular disease | Nurse management, aim for total fat ≤40 g/day | Physician risk management | 1.9, USA |
| MSFAT (Van het Hof 1995)35 | 240 healthy people aged 20-55 | Trial shop - low fat products ad libitum | Trial shop - usual fat products ad libitum | 0.5, Netherlands |
| National Diet Heart Study (Open 1st and 2nd) 196836 | 821 community dwelling men | Diet B: fat 30%, saturated fat <9%, dietary cholesterol 400 mg/day, polyunsaturated fat 15%, polyunsaturated to saturated fat ratio 1.5. Diet X: fat 30%, saturated fat <9%, dietary cholesterol 400 mg/day, polyunsaturated fat 15%, polyunsaturated to saturated fat ratio 1.5 | Fat 40%, saturated fat 16-18%, dietary cholesterol 700 mg/day, polyunsaturated to saturated fat ratio 0.4 | 0.9, USA |
| National Diet Heart Study (Open 2nd) 196836 | 498 community dwelling men | Diet BC fat 30-40%, saturated fat reduced, dietary cholesterol 400 mg/day, polyunsaturated to saturated fat ratio 1.5-2.0 | Fat 40%, saturated fat 16-18%, dietary cholesterol 700 mg/day, polyunsaturated to saturated fat ratio 0.4 | 0.6, USA |
| Nutrition and breast health (Djuric 2002)37 | 122 premenopausal women at increased risk of breast cancer | Total fat 15% | Daily food guide pyramid | 0.8 intervention, 1.0 control, USA |
| Pilkington 196038 | 35 men with angina or who had a myocardial infarction | Fat 20 g/day, avoid dairy except skimmed milk and one egg or 21 g cheese daily. Lean meat and fish each once daily, carbohydrates unlimited | Aims for fat intake unclear, only skimmed milk, 90 mL/day soya oil, lean meat, unsaturated margarine | 1.1, UK |
| Polyp Prevention Trial 199639 40 | 2079 people with one or more large bowel polyps | Fat 20%, 18 g fibre/1000 kcal, 5-8 servings daily of fruit and vegetables | General dietary guidelines | 3.1, USA |
| Rivellese 199441 | 63 adults with primary hyperlipoproteinaemia | Fat 25%, saturated fat 8%, monounsaturated fat 15%, polyunsaturated fat 2%, dietary cholesterol <300 mg/day, carbohydrates 58% | Fat 38%, saturated fat <10%, monounsaturated fat 20%, polyunsaturated fat 10%, dietary cholesterol <300 mg/day, carbohydrates 47% | 0.4, Italy |
| Simon low fat breast cancer 199042 | 194 women at high risk of breast cancer | Total fat 15% | Usual diet | 1.7 intervention, 1.8 control, USA |
| Sondergaard 200343 | 115 people with ischaemic heart disease plus total cholesterol ≥5 mmol/L | Fat and saturated fat reduced, replace fats with oils, 600 g fruit and vegetables daily, fatty fish once or more weekly, carbohydrates freely | Unclear | 1.0, Denmark |
| Strychar 200944 | 30 people with well controlled type 1 diabetes mellitus | Fat 27-30%, saturated fat ≤10%, monounsaturated fat 10%, carbohydrates 54-57% | Fat 38%, saturated fat ≤10%, monounsaturated fat 20%, carbohydrates 45% | 0.5, Canada |
| Swedish breast cancer 199045-47 | 169 women after breast cancer surgery | Fat 20-25%, replace energy with carbohydrates | Usual diet | 1.5 intervention, 1.9 control, Sweden |
| Veterans dermatology (Black 1994)48 | 115 people with non-melanoma skin cancer | Fat 20%, protein 15%, carbohydrates 65% | No dietary advice | 1.9, USA |
| Women’s Healthy Eating and Living (Pierce 2007)49 | 3088 women with breast cancer treated early | Fat 15-20%, increase intake of fruit and vegetables plus 16 oz vegetable juice daily | Fat 30% | 11, USA |
| Women’s Health Initiative (Howard 2006)50 | 48 835 postmenopausal women | Fat 20%, with increased intake of fruit, vegetables, and grains | Unclear, diet related education | 8.1, USA |
| Women’s Health Trial: Feasibility 199051 | 261 women at risk of breast cancer | Fat 20% | Usual diet | 1.9, USA |
| Women’s Health Trial: Feasibility Study in Minority Populations 200351 | 1720 postmenopausal women, diverse ethnic and socioeconomic status | Fat ≤20%, reduced saturated fat and dietary cholesterol, increased fruit, vegetables, and whole grains | Usual diet | Unclear (1.5 maximum), USA |
| Women’s Intervention Nutrition Study (Chlebowski 1993)52 | 2437 women with resected breast cancer | Fat 15-20% | Nutritional adequacy | 5.0, USA |
*Percentages refer to proportion of total energy intake.
†Mean years in trial (not maximal duration).