Introduction
Subjects and methods
Design and study population
RSV+Fib | RSV | SIM/EZE+Fib | SIM+EZE | P-value | |
---|---|---|---|---|---|
N = 28 | N = 30 | N = 28 | n = 30 | ||
Age, years1
| 57 (1) | 60 (2) | 62 (1) | 58 (1) | 0.21 |
Female, n (%)2
| 21 (75) | 20 (67) | 19 (68) | 22 (73) | 0.87 |
Hypertension, n (%)2
| 22 (79) | 24 (80) | 18 (64) | 26 (87) | 0.22 |
Diabetes, n (%)2
| 5 (18) | 7 (23) | 6 (21) | 9 (30) | 0.73 |
Smoking, n (%)2
| 2 (7) | 3 (10) | 1 (4) | 2 (7) | 0.82 |
Metabolic Syndrome, n (%)2
| 17 (61) | 18 (60) | 13 (46) | 14 (47) | 0.53 |
Study drugs and fiber
Blood sample collection and assays
Lipids and biochemistry
Phytosterols and desmosterol
Statistical analyses
Results
Dietary intake, weight and body mass index
RSV+Fib | RSV | SIM/EZE+Fib | SIM+EZE | P-value | |
---|---|---|---|---|---|
N = 28 | N = 30 | N = 28 | n = 30 | ||
MUFA%1
| |||||
Baseline | 13.8 (0.7) | 12.8 (0.7) | 13.4 (1.0) | 11.8 (0.7) | 0.374 |
12 weeks | 12.9 (0.6) | 13.6 (0.8) | 13.4 (0.5) | 11.5 (0.6) | 0.094 |
PUFA%1
| |||||
Baseline | 9.1 (0.6) | 11.9 (1.0) | 10.3 (0.8) | 10.3 (1.0) | 0.329 |
12 weeks | 8.3 (0.8) | 10.7 (1.1) | 9.6 (0.6) | 8.2 (0.7) | 0.098 |
SAFA%1
| |||||
Baseline | 9.7 (0.6) | 9.5 (0.6) | 9.5 (0.5) | 9.1 (0.6) | 0.833 |
12 weeks | 9.3 (0.5) | 9.4 (0.5) | 9.5 (0.7) | 8.9 (0.7) | 0.717 |
Trans FA%1
| |||||
Baseline | 0.3 (0.1) | 0.4 (0.1) | 0.3 (0.1) | 0.3 (0.1) | 0.608 |
12 weeks | 0.3 (0.1) | 0.4 (0.1) | 0.4 (0.2) | 0.4 (0.1) | 0.237 |
Energy Kcal/day2
| |||||
Baseline | 1762 (116) | 1766 (100) | 1828 (156) | 1741 (136) | 0.001a
|
12 weeks | 1653 (116) | 1520 (85) | 1585 (129) | 1599 (102) | 0.990b
|
Lipids%1
| |||||
Baseline | 36.1 (1.4) | 37.3 (1.9) | 36.3 (1.7) | 34.3 (1.8) | 0.941 |
12 weeks | 33.9 (1.4) | 36.9 (1.8) | 35.7 (1.2) | 31.4 (1.6) | 0.041 |
Carbohydrates%1
| |||||
Baseline | 46.4 (1.9) | 46.9 (2.1) | 46.7 (2.3) | 49.2 (2.1) | 0.869 |
12 weeks | 46.3 (1.5) | 46.5 (1.6) | 46.7 (1.7) | 52.1 (1.8) | 0.034 |
Proteins%1
| |||||
Baseline | 18 (1.3) | 16.5 (1.0) | 17.7 (1.3) | 17.3 (0.9) | 0.79 |
12 weeks | 20 (1.0) | 17.6 (0.9) | 18.5 (1.2) | 17.8 (0.8) | 0.268 |
Cholesterol mg/day2
| |||||
Baseline | 214 (29) | 200 (21) | 197 (33) | 210 (29) | 0.203a
|
12 weeks | 222 (29) | 157 (12) | 201 (34) | 171 (22) | 0.683b
|
Fibers g/day2
| |||||
Baseline | 20 (3) | 17 (1) | 22 (3) | 16 (2) | 0.853a
|
12 weeks | 20 (2) | 16 (1) | 18 (2) | 19 (2) | 0.666a
|
Laboratory results
Lipids and apolipoproteins
RSV+Fib | RSV | SIM/EZE+Fib | SIM+EZE | P-value1
| P-value2
| |
---|---|---|---|---|---|---|
N = 28 | N = 30 | N = 28 | n = 30 | |||
Weight kg | ||||||
Baseline | 74 (3) | 72 (2) | 73 (3) | 70 (2) | 0.001 | 0.803 |
12 weeks | 73 (3) | 72 (3) | 72 (3) | 70 (2) | ||
BMI kg/m2
| ||||||
Baseline | 28 (1) | 30 (1) | 30 (1) | 28 (1) | 0.005 | 0.246 |
12 weeks | 27 (1) | 30 (1) | 29 (1) | 28 (1) | ||
Glucose mg/dL | ||||||
Baseline | 97 (2) | 104 (4) | 103 (5) | 108 (7) | 0.754 | 0.257 |
12 weeks | 95 (2) | 104 (4) | 100 (4) | 109 (6) | ||
HbA1c % | ||||||
Baseline | 5.7 (0.1) | 6.3 (0.2) | 6.0 (0.2) | 6.2 (0.2) | 0.02 | 0.215 |
12 weeks | 5.8 (0.1) | 6.2 (0.2) | 6.1 (0.2) | 6.3 (0.2) | ||
hsCRP mg/L | ||||||
Baseline | 4.2 (1.1) | 3.7 (0.5) | 3.3 (0.4) | 4.5 (1.3) | <0.001 | 0.976 |
12 weeks | 2.4 (0.5) | 2.5 (0.4) | 2.3 (0.4) | 2.3 (0.4) | ||
Cholesterol mg/dL | ||||||
Baseline | 256 (10) | 244 (8) | 247 (8) | 241 (9) | <0.0001 | 0.639 |
12 weeks | 149 (6) | 140 (5) | 155 (9) | 147 (8) | ||
LDL-C mg/dL | ||||||
Baseline | 167 (8) | 154 (7) | 162 (6) | 158 (8) | <0.001 | 0.436 |
12 weeks | 70 (5) | 64 (4) | 80 (8) | 72 (4) | ||
HDL-C mg/dL | ||||||
Baseline | 57 (3) | 52 (2) | 52 (2) | 54 (2) | 0.392 | 0.351 |
12 weeks | 57 (3) | 50 (3) | 53 (3) | 52 (2) | ||
Triglycerides mg/dL | ||||||
Baseline | 160 (13) | 187 (16) | 158 (14) | 144 (10) | <0.001 | 0.291 |
12 weeks | 110 (9) | 123 (8) | 110 (7) | 108 (9) | ||
Apoliprotein A1 mg/dL | ||||||
Baseline | 153 (6) | 145 (6) | 141 (4) | 147 (3) | 0.035 | 0.482 |
12 weeks | 155 (6) | 149 (6) | 145 (5) | 152 (4) | ||
Apoliprotein B mg/dL | ||||||
Baseline | 133 (6) | 133 (5) | 133 (5) | 134 (6) | <0.001 | 0.775 |
12 weeks | 68 (3) | 67 (3) | 73 (5) | 70 (4) | ||
Campesterol mg/dL | ||||||
Baseline | 1.2 (0.2) | 1.1 (0.1) | 0.9 (0.1) | 1.3 (0.2) | <0.001 | 0.005 |
12 weeks | 0.9 (0.1) | 1.0 (0.1) | 0.5 (0.1) | 0.8 (0.1) | ||
β-sitosterol mg/dL | ||||||
Baseline | 0.7 (0.1) | 0.8 (0.1) | 0.6 (0.1) | 0.9 (0.1) | 0.03 | 0.072 |
12 weeks | 0.6 (0.6) | 0.7 (0.1) | 0.5 (0.1) | 0.6 (0.1) | ||
Desmosterol mg/dL | ||||||
Baseline | 0.7 (0.1) | 1.9 (1.6) | 0.9 (0.3) | 0.5 (0.1) | 0.005 | 0.373 |
12 weeks | 0.6 (0.1) | 0.9 (0.5) | 1.0 (0.3) | 1.6 (0.5) |