Table 3.
Study design and population characteristics of clinical trials of plant-based diets and plasma lipids
| Reference, country | Study design and duration | Jadad score | N | Mean age (y) | Percent male | Mean BMI (kg/m2) | Mean baseline plasma lipids (mg/dL) |
Medication use | Intervention diet | Control diet | Comorbidities | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TC | LDL-C | HDL-C | TG | |||||||||||
| Kestin et al (1989),44 Australia | RCT (CO), 6 wk | 2 | 26 | 44.0 | 100 | 25.5 | 234.7 | 157.8 | 56.5 | 113.4 | None | Lacto-ovo | Omnivorous | Not on hyperlipoproteinemia or hypertension medication |
| Ling et al (1992),54 Finland | RCT (PL), 4 wk | 2 | 18 | 42.8 | 22.2 | 26.6 | 213.3 | 141.5 | 50.1 | 102.3 | NR | Vegan | Omnivorous | 2 coronary heart disease, 1 obesity, 1 hypertension |
| Ornish et al (1998),42 USA | RCT (PL), 48 wk | 3 | 35 | 59.3 | 91.4 | 27.1 | 234.9 | 153.5 | 45.3 | 225.9 | None | Ornish (low-fat lacto-ovo) | Omnivorous | Coronary heart disease |
| Nicholson et al (1999),53 USA | RCT (PL), 12 wk | 2 | 11 | 54.3 | 54.5 | NR | 207.6 | NR | 44.0 | 193.2 | 36.4 % | Low-fat vegan | Omnivorous | Non–insulin-dependent diabetes mellitus |
| Barnard et al (2000),45 USA | RCT (CO), 8 wk | 3 | 35 | 36.1 | 0 | 25.5 | 163.0 | 97.0 | 49.0 | 81.0 | None | Low-fat vegan | Omnivorous | Healthy premenopausal women |
| Agren et al (2001),46 Finland | RCT (PL), 12 wk | 2 | 29 | 50.8 | 3.4 | 24.3 | 190.3 | 126.8 | 45.5 | 89.7 | None | Vegan | Omnivorous | Rheumatoid arthritis |
| Dansinger et al (2005),58 USA | RCT (PL), 48 wk | 3 | 80 | 49.0 | 50.0 | 35.0 | 217.5 | 139.0 | 46.0 | 164.0 | Mean of 2.4 medications per person | Ornish (low-fat lacto-ovo) | Calorie restriction | Presence of at least 1 of the metabolic cardiac risk factors |
| Gardner et al (2005),43 USA | RCT (PL), 4 wk | 3 | 120 | 48.5 | 50.0 | 26.5 | 224.3 | 148.9 | 48.3 | 128.5 | None | Lacto-ovo | Omnivorous (low-fat) | No heart disease or diabetes |
| de Mello et al (2006),40 Brazil | RCT (CO), 4 wk | 2 | 17 | 59.0 | 82.4 | 26.2 | 206.5 | 132.3 | 45.2 | 139.1 | None | Lacto (low-protein) | Omnivorous | T2D |
| Aldana et al (2007),55 USA | RCT (PL), 48 wk | 2 | 93 | 61.6 | 56.3 | 31.0 | 170.2 | 95.4 | 43.4 | 157.1 | Yes, unknown percentage | Ornish (low-fat lacto-ovo) | Omnivorous | Coronary heart disease |
| Burke et al (2007),50 USA | RCT (PL), 72 wk | 2 | 176 | 44.0 | 13.1 | 34.0 | 204.0 | NR | NR | 134.0 | None | Lacto-ovo (calorie- and fat-restricted) | Omnivorous (calorie- and fat-restricted) | Overweight and obese |
| Gardner et al (2007),57 USA | RCT (PL), 48 wk | 2 | 155 | 41.0 | 0.0 | 31.5 | NR | 107.4 | 50.5 | 118.5 | None | Ornish (low-fat lacto-ovo) | Calorie restriction | Overweight in premenopause |
| Elkan et al (2008),41 Sweden | RCT (PL), 12 wk | 2 | 58 | 50.3 | 10.3 | 24.0 | 191.7 | 118.1 | 52.3 | 97.4 | None | Vegan | Omnivorous | Rheumatoid arthritis |
| Barnard et al (2009),49 USA | RCT (PL), 74 wk | 3 | 99 | 55.6 | 39.4 | 34.9 | 193.0 | 111.1 | 51.0 | 153.2 | 54.5 % | Low-fat vegan | ADA diet | T2D |
| Miller et al (2009),56 USA | RCT (CO), 4 wk | 2 | 18 | 30.6 | 50.0 | 22.6 | 184.9 | 107.2 | 62.2 | 78.1 | None | Ornish (low-fat lacto-ovo) | Mediterranean South Beach | Healthy (no history of metabolic, hepatic, renal, or systemic disease) |
| Ferdowsian et al (2010),51 USA | CT (PL), 22 wk | 1 | 107 | 21–65 | 17.7 | NR | 186.5 | 105.4 | 51.8 | 147.2 | Yes, unknown percentage | Low-fat vegan | Omnivorous | BMI ≥ 25 and/or T2D |
| Kahleova et al (2013),48 Czech Republic | RCT (PL), 24 wk | 2 | 74 | 56.2 | 47.3 | 35.1 | 166.3 | 98.8 | 41.8 | 186.0 | 51.4 % | Lacto | EASD diet | T2D |
| Mishra et al (2013),52 USA | RCT (PL), 18 wk | 3 | 291 | 45.2 | 17.2 | 35.0 | 187.6 | 108.2 | 55.2 | 121.4 | NR | Low-fat vegan | Omnivorous | BMI ≥ 25 and/or T2D |
| Bunner et al (2014),47 USA | RCT (CO), 16 wk | 3 | 42 | 45.7 | 7.1 | 27.6 | 187.1 | 106.0 | 61.5 | 96.1 | NR | Low-fat vegan | Omnivorous | Migraine |
Abbreviations: ADA, American Diabetes Association; BMI, body mass index; CT, clinical trial; CO, crossover; EASD, European Association for the Study of Diabetes; NR, not reported; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; PL, parallel; RCT, randomized controlled trial; TC, total cholesterol; TG, triglycerides; T2D, type 2 diabetes.