Table 4.
Initial and final data of clinical characteristics and plasma levels of main-study subjects
(Mean values and standard deviations; numbers of subjects)
| Group… | Test: GLUCODIA™ | Control: casein | ||||||
|---|---|---|---|---|---|---|---|---|
| Consumption period (week)… | 0 | 8 | 0 | 8 | ||||
| Mean | sd | Mean | sd | Mean | sd | Mean | sd | |
| Subjects (n) | 22 | 22 | ||||||
| Male | 10 | 9 | ||||||
| Female | 12 | 13 | ||||||
| Age (years) | ||||||||
| Mean | 41·6 | 42·8 | ||||||
| sd | 1·8 | 1·8 | ||||||
| Ethnicity (n) | ||||||||
| White | 15 | 19 | ||||||
| Hispanic | 3 | 1 | ||||||
| African-American | 0 | 0 | ||||||
| Asian | 2 | 2 | ||||||
| American Indian/Alaska Native | 2 | 0 | ||||||
| Native Hawaian/Pacific Islander | 0 | 0 | ||||||
| Other | 0 | 0 | ||||||
| Weight (kg) | 86·5 | 10·3 | 83·3 | 20·0 | 92·4 | 11·7 | 90·4 | 12·6 |
| BMI (kg/m2) | 30·5 | 3·0 | 31·0 | 3·3 | 30·7 | 2·9 | 30·6 | 3·0 |
| Body fat ratio (%) | 40·6 | 6·7 | 40·1 | 7·7 | 37·5 | 9·4 | 37·3 | 10·8 |
| Fat body mass (g) | 33 772 | 6446 | 33 509 | 7588 | 33 304 | 9197 | 33 057 | 10 853 |
| Lean body mass (g) | 49 616 | 8795 | 50 132 | 9465 | 55 565 | 11 059 | 55 418 | 11 605 |
| Fasting plasma glucose (mg/dl)§ | 102 | 9 | 99 | 10 | 97 | 8 | 98 | 12 |
| Insulin (μU/ml) | 14·9 | 6·0 | 10·8** | 4·7 | 12·2 | 4·8 | 13·7 | 7·6 |
| HOMA-IR | 3·8 | 1·8 | 2·9** | 1·9 | 2·8 | 1·2 | 3·3 | 2·5 |
| HbA1c (%) | 5·59 | 0·31 | 5·59 | 0·28 | 5·50 | 0·27 | 5·45 | 0·23 |
| TAG (mg/dl)ǁ | 153 | 70 | 142‡ | 70 | 136 | 45 | 146 | 48 |
| Total cholesterol (mg/dl)¶ | 197 | 37 | 190 | 40 | 197 | 22 | 195 | 31 |
| LDL-cholesterol (mg/dl)¶ | 122 | 33 | 114 | 31 | 119 | 21 | 119 | 23 |
| HDL-cholesterol (mg/dl)¶ | 50 | 12 | 47* | 14 | 51 | 9 | 48** | 9 |
| NEFA (mEq/l) | 530 | 311 | 460 | 213 | 383 | 199 | 428 | 238 |
| AST (IU/l) | 24·2 | 11·1 | 24·7 | 5·7 | 26·2 | 6·8 | 25·8 | 7·8 |
| ALT (IU/l) | 35·3 | 15·1 | 30·6* | 13·6 | 31·0 | 12·1 | 31·6 | 14·8 |
| γ-GTP (IU/l) | 29·2 | 19·8 | 28·9 | 17·6 | 26·2 | 27·8 | 26·2 | 21·3 |
| Adiponectin (μg/ml) | 8·31 | 4·90 | 13·52** | 9·19 | 13·09† | 5·82 | 11·44 | 5·48 |
HOMA-IR, homeostatic model assessment of insulin resistance; HbA1c, glycated Hb; AST, aspartate aminotransferase; ALT, alanine aminotransferase; γ-GTP, γ-glutamyltransferase.
Significant difference between baseline and 8-week data: * P < 0·05, ** P < 0·01.
† Significant difference between test and control data (P < 0·05).
‡ Significant tendency between test and control data (P < 0·1).
§ To convert glucose from mg/dl to mmol/l, multiply by 0·0555.
ǁ To convert TAG from mg/dl to mmol/l, multiply by 0·0113.
¶ To convert cholesterol from mg/dl to mmol/l, multiply by 0·0259.