TABLE 1.
Characteristics of randomized controlled clinical trials included in the systematic review1
| Study (ref.) | Country | Group: n and sex (F/M) | Mean age, y | RCT design | Period, d | Intervention diet | Control diet | Participants | Estimated effect sizes: WMD (95% CI) |
|---|---|---|---|---|---|---|---|---|---|
| Irish et al. (33) | United States | Intervention: 7 F/1 M Control: 8 F/1 M |
Intervention: 35.4 Control: 37.1 |
Parallel | 90 | Modified Paleolithic diet | Usual diet | Relapsing-remitting multiple sclerosis | CRP (mg/L): −1.69 (−3.73, 0.35) |
| Genoni et al. (57) | Australia | Intervention: 22 F Control: 17 F |
Intervention: 47 Control: 47 |
Parallel | 28 | Paleolithic diet: CHO: 27.8% Fat: 39.8% Pro: 26.8% |
AGHE: CHO: 40.6% Fat: 32.6% Pro: 21.7% |
Healthy women | Weight (kg): −1.99 (−2.94, −1.04) WC (cm): −1.90 (−3.09, −0.71) Body fat (%): −1.34 (−2.48, −0.20) |
| SBP (mm Hg): −2.61 (−10.11, 4.89) DBP (mm Hg): −3.51 (−9.01, 1.99) CRP (mg/L): −0.57 (−1.62, 0.48) TC (mmol/L): −0.13 (−0.48, 0.22) TGs (mmol/L): −0.14 (−0.44, 0.16) HDL cholesterol (mmol/L): 0.04 (−0.06, 0.14) LDL cholesterol (mmol/L): −0.11 (−0.31, 0.09) |
|||||||||
| Masharani et al. (59) | United States | Intervention: 14 NR Control: 10 NR |
Intervention: 58 Control: 56 |
Parallel | 21 | Paleolithic diet: CHO: 58.2% Fat: 27% Pro: 18.5% |
ADA diet: CHO: 54.4% Fat: 28.8% Pro: 20.3% |
Patients with type 2 diabetes | Weight (kg): −0.30 (−1.38, 0.78) SBP (mm Hg): −2.00 (−12.08, 8.08) DBP (mm Hg): −1.00 (−8.27, 6.27) TC (mmol/L): −0.44 (−0.99, 0.11) TGs (mmol/L): −0.20 (−0.69, 0.29) HDL cholesterol (mmol/L): −0.05 (−0.21, 0.11) LDL cholesterol (mmol/L): −0.21 (−0.63, 0.21) |
| Stomby et al. (58) | Sweden | Intervention: 27 F Control: 22 F |
NR | Parallel | 180 | Paleolithic diet: CHO: 30% Fat: 40% Pro: 30% |
NNR: CHO: 55–60% Fat: 25–30% Pro: 15% |
Overweight postmenopausal women | Body fat (%): −1.90 (−3.64, −0.16) |
| Mellberg et al. (31) | Sweden | Intervention: 34 F Control: 27 F |
Intervention: 59.5 Control: 60.3 |
Parallel | 180 | Paleolithic diet: CHO: 30% Fat: 40% Pro: 30% |
NNR: CHO: 55–60% Fat: 25–30% Pro: 15% |
Postmenopausal nonsmoking women with a BMI ≥ 27 | Weight (kg): −4.90 (−8.30, −1.50) WC (cm): −5.30 (−8.52, −2.08) BMI: −1.80 (−2.61, −0.99) SBP (mm Hg): −3.70 (−9.57, 2.17) DBP (mm Hg): −1.60 (−5.16, 1.96) CRP (mg/L): −0.20 (−0.73, 0.33) TC (mmol/L): −0.28 (−0.67, 0.11) TGs (mmol/L): −0.26 (−0.46, −0.06) HDL cholesterol (mmol/L): −0.01 (−0.14, 0.12) LDL cholesterol (mmol/L): −0.14 (−0.43, 0.15) |
| Boers et al. (30) | Netherlands | Intervention: 13 F/5 M Control: 12 F/4 M |
Intervention: 52 Control: 55.4 |
Parallel | 14 | Paleolithic diet: CHO: 32% Fat: 41% Pro: 24% |
Guidelines for a healthy diet of the DHC: CHO: 50% Fat: 29% Pro: 17% |
Subjects with characteristics of the metabolic syndrome | Weight (kg): −1.00 (−7.82, 5.82) WC (cm): −0.10 (−4.66, 4.46) BMI: −0.80 (−3.14, 1.54) SBP (mm Hg): −4.00 (−10.21, 2.21) DBP (mm Hg): −5.00 (−9.55, −0.45) CRP (mg/L): −0.50 (−2.13, 1.13) TC (mmol/L): −0.60 (−1.09, −0.11) TGs (mmol/L): −1.00 (−1.52, −0.48) HDL cholesterol (mmol/L): 0.20 (0.03, 0.37) LDL cholesterol (mmol/L): −0.30 (−0.75, 0.15) |
| Jönsson et al. (19) | Sweden | 3 F/10 M | 64 | Crossover | 90 | Paleolithic diet: CHO: 32% Fat: 39% Pro: 24% |
Diabetes diet designed in accordance with current diabetes dietary guidelines: CHO: 42% Fat: 34% Pro: 20% |
Patients with type 2 diabetes | Weight (kg): −3.00 (−6.53, 0.53) WC (cm): −4.00 (−6.94, −1.06) BMI: −1.00 (−2.45, 0.45) SBP (mm Hg): −9.00 (−13.66, −4.34) DBP (mm Hg): −4.00 (−6.14, −1.86) CRP (mg/L): −0.60 (−1.05, −0.15) TC (mmol/L): −0.20 (−0.45, 0.05) TGs (mmol/L): −0.50 (−0.65, −0.35) HDL cholesterol (mmol/L): 0.08 (0.02, 0.14) LDL cholesterol (mmol/L): −0.10 (−0.32, 0.12) |
| Lindeberg et al. (25) | Sweden | Intervention: 14 M Control: 15 M |
Intervention: 65 Control: 57 |
Parallel | 84 | Paleolithic diet: CHO: 40.2% Fat: 26.9% Pro: 27.9% |
Mediterranean-like diet: CHO: 51.7% Fat: 24.7% Pro: 20.5% |
Ischemic heart disease patients with WC > 94 cm and increased blood glucose or known diabetes | Weight (kg): −1.20 (−3.29, 0.89) WC (cm): −2.70 (−4.86, −0.54) Body fat (%): −1.00 (−2.20, 0.20) SBP (mm Hg): 0.81 (−8.47, 10.09) DBP (mm Hg): 1.07 (−5.71, 7.85) TC (mmol/L): 0.39 (−0.27, 1.05) TGs (mmol/L): 0.28 (−0.19, 0.75) HDL cholesterol (mmol/L): 0.07 (−0.07, 0.21) |
1
BMI measured in kg/m2. ADA, American Diabetes Association; AGHE, Australian Guide to Healthy Eating; CHO, carbohydrate; CRP, C-reactive protein; DBP, diastolic blood pressure; DHC, Dutch Health Council; NNR, Nordic Nutrition Recommendations; NR, not reported; Pro, protein; RCT, randomized controlled trial; ref., reference; SBP, systolic blood pressure; TC, total cholesterol; TG, triglyceride; WC, waist circumference; WMD, weighted mean difference.