A 2-Week Course of Enteral Treatment with a Very Low-Calorie Protein-Based Formula for the Management of Severe Obesity
Table 3
Changes in hematological and biochemical safety parameters after the intervention (per-protocol population; ).
Variable
Baseline
Day 14
Mean difference
valuea
Laboratory range
New cases
Mean (SD)
Mean (SD)
95% CI
Below the lower limit (%)a
Above the upper limit (%)
Hemoglobin, g/L
14.0 (1.5)
14.1 (1.4)
0.1 0.03, 0.19
0.005
12.0–15.5 (13.5–17.0)
12 (3.6)
5 (1.5)
Lymphocytes, /mm3
2334 (651)
1946 (587)
−388 −446, −330
<0.001
1300–3600
23 (6.8)
2 (0.6)
Blood urea nitrogen, mg/dL
31 (8)
26.7 (7.5)
−3.9 −4.8, −3.0
<0.001
10–50
0
1 (0.3)
Creatinine, mg/dL
0.71 (0.15)
0.77 (0.16)
0.06 0.05, 0.08
<0.001
0.55–1.2
7 (2.1)
1 (0.3)
Uric acid, mg/dL
5.6 (1.2)
8.1 (2.3)
2.5 2.2, 2.8
<0.001
3.5–7.0
0
178 (52.7)
Albumin, g/L
44.4 (0.5)
45.9 (0.5)
1.5 −1.0, 2.1
<0.001
35.0–52.0
2 (0.6)
8 (2.4)
Cholinesterase, UI/dL
9839 (1906)
9617 (1893)
−222 −351, −94
<0.001
4250–11250
2 (0.6)
21 (6.2)
AST, UI/dL
23 (10)
34 (17)
11 10, 13
<0.001
6–39
0
34 (10.1)
ALT, UI/dL
32 (21)
47 (32)
15 13, 18
<0.001
6–34
0
90 (26.6)
γ-GT, UI/dL
30 (31)
22 (13)
8 −10, −5
<0.001
6–42
0
4 (1.2)
CPK, UI/dL
121 (75)
134 (88)
13 5, 22
0.003
24–190
0
37 (10.9)
LDH, UI/dL
424 (87)
438 (98)
14 5, 23
0.002
125–600
0
21 (6.2)
Sodium, mEq/L
139 (2.2)
138 (2.5)
−1.0 −1.5, −0.9
<0.001
135–153
21 (6.2)
0
Potassium, mEq/L
4.4 (0.3)
4.5 (0.3)
0.1 0.04, 0.14
<0.001
3.5–5.3
1 (0.3)
3 (0.9)
Magnesium, mg/dL
1.98 (0.17)
1.93 (0.18)
−0.05 −0.08, −0.04
<0.001
1.7–2.6
5 (1.5)
0
Calcium, mg/dL
9.3 (0.4)
9.6 (0.4)
0.4 0.3, 0.4
<0.001
8.6–10.5
1 (0.3)
4 (1.2)
Phosphorus, mg/dL
3.4 (0.5)
3.7 (0.5)
0.3 0.3, 0.4
<0.001
2.7–4.5
3 (0.9)
15 (4.4)
BMI: body mass index; AST: aspartate aminotransferase; ALT: alanine aminotransferase; -GT: gamma glutamyl transferase; CPK: creatine phosphokinase; LDH: lactate dehydrogenase. aBaseline versus end of study (by Student’s -test for paired data or Fisher’s exact test).
