Table 3.
Outcome measures for the WHOLEheart study*
(Median values and standard deviations)
| Baseline |
Week 8 |
Week 16 |
||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control |
Intervention 1 |
Intervention 2 |
Control |
Intervention 1 |
Intervention 2 |
Control |
Intervention 1 |
Intervention 2 |
||||||||||
| Median | SD | Median | SD | Median | SD | Median | SD | Median | SD | Median | SD | Median | SD | Median | SD | Median | SD | |
| Minimisation | ||||||||||||||||||
| Age | 45·6 | 10 | 45·9 | 10·1 | 45·7 | 9·9 | – | – | – | – | – | – | – | – | – | – | – | – |
| Percentage male | 49·0 | 50·0 | 51·2 | – | – | – | – | – | – | – | – | – | – | – | – | |||
| BMI (kg/m2) | 30·0 | 4·0 | 30·0 | 3·7 | 30·3 | 4·5 | – | – | – | – | – | – | – | – | – | – | – | – |
| Anthropometry | ||||||||||||||||||
| Weight (kg) | 86·7 | 14·0 | 86·7 | 14·2 | 86·0 | 13·2 | 87·1 | 14·0 | 86·9 | 14·5 | 86·3 | 13·2 | 86·7 | 13·8 | 87·4 | 14·8 | 86·2 | 13·0 |
| Body fat (%) | 34·6 | 9·1 | 34·0 | 8·3 | 33·3 | 9·4 | 34·2 | 9·1 | 34·8 | 8·5 | 33·4 | 9·1 | 34·9 | 9·0 | 35·0 | 8·2 | 33·6 | 9·5 |
| Systolic BP (mmHg) |
127·3 | 14·8 | 125·5 | 16·1 | 129·5 | 15·5 | 126·0 | 15·0 | 125·5 | 16·9 | 127·3 | 16·3 | 124·3 | 14·9 | 123·5 | 17·4 | 126·8 | 16·2 |
| Diastolic BP (mmHg) |
79·8 | 10·2 | 79·0 | 9·8 | 79·0 | 9·3 | 78·5 | 10·5 | 78·8 | 10·6 | 77·5 | 10·3 | 77·0 | 9·7 | 76·5 | 10·0 | 77·8 | 10·1 |
| Lipid profile | ||||||||||||||||||
| Total cholesterol (mmol/l) |
5·2 | 1·0 | 5·1 | 0·8 | 5·3 | 1·0 | 5·2 | 1·1 | 5·2 | 0·8 | 5·4 | 1·0 | 5·4 | 1·0 | 5·2 | 0·9 | 5·5 | 1·1 |
| HDL-cholesterol (mmol/l) |
1·3 | 0·3 | 1·3 | 0·3 | 1·3 | 0·2 | 1·3 | 0·3 | 1·3 | 0·3 | 1·3 | 0·3 | 1·4 | 0·3 | 1·3 | 0·3 | 1·3 | 0·3 |
| LDL-cholesterol (mmol/l) |
3·2 | 0·9 | 3·2 | 0·7 | 3·3 | 0·8 | 3·1 | 0·9 | 3·2 | 0·7 | 3·3 | 0·8 | 3·2 | 0·9 | 3·3 | 0·8 | 3·4 | 0·9 |
| TAG (mmol/l) | 1·5 | 1·0 | 1·4 | 0·8 | 1·4 | 0·8 | 1·4 | 0·9 | 1·4 | 1·0 | 1·3 | 0·9 | 1·4 | 0·8 | 1·3 | 0·9 | 1·5 | 0·8 |
| NEFA (mmol/l) | 0·52 | 0·23 | 0·55 | 0·19 | 0·51 | 0·2 | 0·50 | 0·18 | 0·54 | 0·21 | 0·48 | 0·19 | 0·50 | 0·2 | 0·51 | 0·17 | 0·44 | 0·20 |
| Insulin sensitivity | ||||||||||||||||||
| Glucose (mmol/l) | 5·5 | 0·5 | 5·6 | 0·7 | 5·4 | 0·7 | 5·5 | 0·6 | 5·5 | 0·8 | 5·5 | 0·8 | 5·5 | 0·6 | 5·4 | 1·0 | 5·4 | 0·5 |
| Insulin (pmol/l) | 59·2 | 34·3 | 53·7 | 53·4 | 49·6 | 33·0 | 62·3 | 47·2 | 55·8 | 58·1 | 54·2 | 30·8 | 59·6 | 66·1 | 50·5 | 46·0 | 57·7 | 32·1 |
| Modified QUICKI | 0·38 | 0·06 | 0·38 | 0·05 | 0·40 | 0·05 | 0·39 | 0·05 | 0·39 | 0·04 | 0·39 | 0·05 | 0·38 | 0·05 | 0·39 | 0·04 | 0·39 | 0·05 |
| Endothelial function | ||||||||||||||||||
| ICAM-1 (ng/ml) | 222 | 52·1 | 215 | 41·4 | 221 | 46·3 | 222 | 59·2 | 223·0 | 39·0 | 225 | 50·6 | 231 | 58·4 | 219 | 45·8 | 229 | 57·8 |
| VCAM-1 (ng/ml) | 661 | 135 | 686 | 141 | 711 | 131 | 663 | 130 | 667 | 139 | 687 | 138 | 667 | 140 | 670 | 146 | 687 | 143 |
| E-selectin (ng/ml) | 32·3 | 13·3 | 30·3 | 13·7 | 30·2 | 13·0 | 32·0 | 11·9 | 32·0 | 11·9 | 29·7 | 13·6 | 35·1 | 12·8 | 35·1 | 12·8 | 30·5 | 14·0 |
| Inflammatory status | ||||||||||||||||||
| Sialic acid (mg/l) | 671 | 83 | 683 | 82 | 701 | 93 | 668 | 89 | 691 | 75 | 704 | 89 | 671 | 92 | 676 | 78 | 691 | 102 |
| CRP (mg/l) | 2·4 | 2·3 | 2·4 | 9·9 | 3·2 | 4·6 | 2·7 | 2·8 | 2·6 | 2·5 | 3·5 | 7·2 | 2·9 | 3·5 | 3·1 | 4·3 | 3·2 | 5·9 |
| Fibrinogen (g/l) | 3·1 | 0·6 | 3·1 | 0·7 | 3·2 | 0·8 | 3·0 | 0·7 | 3·2 | 0·7 | 3·3 | 0·9 | 3·1 | 0·6 | 3·2 | 0·7 | 3·2 | 0·9 |
| PAI-1 (ng/ml) | 18·1 | 42·9 | 14·4 | 40·9 | 11·6 | 27·9 | 18·3 | 35·8 | 16·1 | 34·3 | 15·0 | 35·2 | 17·0 | 31·2 | 13·9 | 30·6 | 12·7 | 31·4 |
BP, blood pressure; QUICKI, quantitative insulin sensitivity check index; ICAM-1, intercellular adhesion molecule 1; VCAM-1, vascular cell adhesion molecule 1; CRP, C-reactive protein; PAI-1, plasminogen activator inhibitor-1.
*
Age, sex (percentage male) and BMI were used in participant randomisation.