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Table 4 Biochemical parameters values at baseline and following 15 weeks of double-blind treatment

From: Safety of phosphatidylserine containing omega-3 fatty acids in non-demented elderly: a double-blind placebo-controlled trial followed by an open-label extension

 

PS-DHA

Placebo

Variable

Baseline (mean ± SD)

15 weeks (mean ± SD)

P value1 (within group)

Baseline (mean ± SD)

15 weeks (mean ± SD)

P value1 (within group)

P value2 (between groups)

   Glucose (mg/dL)

106.6 ± 34.0

105.9 ± 37.1

0.885

103.4 ± 30.7

111.1 ± 47.3

0.082

0.175

   Male

115.1 ± 42.0

110.4 ± 47.4

0.551

105.8 ± 33.6

118.3 ± 59.9

0.076

0.101

   Female

98.0 ± 20.7

101.5 ± 22.5

0.330

100.6 ± 27.3

102.9 ± 25.6

0.662

0.847

   Sodium (mmol/L)

140.6 ± 2.6

140.9 ± 2.7

0.316

140.9 ± 2.1

140.3 ± 2.3

0.014*

0.017*

   Male

140.6 ± 2.6

140.9 ± 2.7

0.352

141.2 ± 2.0

140.6 ± 2.1

0.092

0.061

   Female

140.5 ± 2.7

140.8 ± 2.7

0.582

140.6 ± 2.2

140.0 ± 2.5

0.079

0.136

   Calcium (mg/dL)

9.6 ± 0.6

9.6 ± 0.5

0.452

9.4 ± 0.6

9.6 ± 0.5

0.012*

0.038*

   Male

9.5 ± 0.4

9.5 ± 0.5

0.966

9.4 ± 0.3

9.5 ± 0.4

0.189

0.413

   Female

9.8 ± 0.7

9.6 ± 0.5

0.371

9.5 ± 0.8

9.7 ± 0.5

0.032*

0.051

   Phosphorus (mg/dL)

3.4 ± 0.6

3.3 ± 0.5

0.103

3.4 ± 0.5

3.3 ± 0.5

0.346

0.807

   Male

3.2 ± 0.6

3.1 ± 0.5

0.190

3.2 ± 0.5

3.2 ± 0.5

0.636

0.671

   Female

3.7 ± 0.5

3.6 ± 0.5

0.326

3.5 ± 0.6

3.4 ± 0.5

0.397

0.932

   Chloride (mmol/L)

101.6 ± 3.1

102.4 ± 3.0

0.010*

101.9 ± 3.1

101.8 ± 2.3

0.880

0.047*

   Male

101.9 ± 2.8

102.6 ± 3.0

0.094

102.1 ± 3.0

102.1 ± 2.2

1.000

0.262

   Female

101.2 ± 3.4

102.2 ± 2.9

0.053

101.6 ± 3.4

101.5 ± 2.4

0.819

0.104

   Potassium (mmol/L)

4.6 ± 0.5

4.5 ± 0.3

0.031*

4.6 ± 0.5

4.7 ± 0.7

0.703

0.128

   Male

4.8 ± 0.7

4.6 ± 0.4

0.095

4.7 ± 0.4

4.7 ± 0.6

0.977

0.221

   Female

4.5 ± 0.3

4.4 ± 0.3

0.173

4.6 ± 0.6

4.6 ± 0.8

0.638

0.345

   BUN (mg/dL)

18.5 ± 4.9

18.9 ± 4.8

0.321

18.6 ± 5.2

19.7 ± 6.7

0.039*

0.262

   Male

19.6 ± 4.8

19.9 ± 4.9

0.679

20.5 ± 5.3

21.7 ± 7.2

0.101

0.249

   Female**

17.4 ± 4.9

18.0 ± 4.7

0.345

16.3 ± 4.1

17.3 ± 5.3

0.225

0.680

   Creatinine (mg/dL)

0.9 ± 0.2

0.9 ± 0.2

0.223

0.9 ± 0.2

0.9 ± 0.2

0.416

0.953

   Male

1.0 ± 0.2

1.0 ± 0.2

0.507

1.0 ± 0.3

1.0 ± 0.3

0.617

0.420

   Female

0.8 ± 0.1

0.8 ± 0.2

0.237

0.7 ± 0.2

0.8 ± 0.2

0.041*

0.265

   Alkaline Phosphatase (U/L)

68.3 ± 22.5

67.3 ± 22.6

0.331

69.9 ± 30.0

69.4 ± 27.8

0.578

0.726

   Male

69.6 ± 24.9

68.0 ± 25.7

0.380

73.3 ± 36.2

72.1 ± 33.0

0.286

0.842

   Female

67.1 ± 20.1

66.7 ± 19.4

0.693

66.0 ± 20.8

66.3 ± 20.3

0.862

0.724

   ALT/SGPT (U/L)

23.9 ± 26.4

20.7 ± 8.4

0.282

19.3 ± 6.4

19.5 ± 5.8

0.733

0.262

   Male

28.9 ± 36.3

22.3 ± 9.7

0.273

19.2 ± 5.9

19.2 ± 5.8

1.000

0.276

   Female

18.9 ± 6.8

19.0 ± 6.6

0.869

19.5 ± 7.1

19.9 ± 5.8

0.655

0.794

   AST/SGOT (U/L)

25.2 ± 20.8

22.4 ± 6.1

0.250

21.9 ± 6.2

21.8 ± 5.3

0.879

0.280

   Male

28.6 ± 28.6

23.3 ± 7.1

0.276

21.8 ± 5.7

21.3 ± 5.5

0.536

0.329

   Female

21.9 ± 6.5

21.5 ± 5.0

0.685

21.9 ± 6.8

22.3 ± 5.0

0.704

0.577

   Total Bilirubin (mg/dL)

0.6 ± 0.2

0.6 ± 0.3

0.361

0.6 ± 0.3

0.6 ± 0.3

0.673

0.747

   Male

0.6 ± 0.3

0.6 ± 0.3

0.097

0.7 ± 0.3

0.7 ± 0.3

0.325

0.753

   Female

0.5 ± 0.2

0.5 ± 0.2

0.699

0.5 ± 0.2

0.5 ± 0.2

0.423

0.826

   Total Protein (g/dL)

7.3 ± 0.4

7.3 ± 0.4

0.190

7.3 ± 0.5

7.4 ± 0.5

0.188

0.936

   Male

7.3 ± 0.4

7.3 ± 0.5

0.358

7.3 ± 0.4

7.3 ± 0.5

0.990

0.489

   Female

7.3 ± 0.4

7.3 ± 0.4

0.362

7.4 ± 0.6

7.5 ± 0.4

0.091

0.443

   Triglycerides (mg/dL)

141.6 ± 61.4

133.0 ± 70.0

0.133

128.9 ± 54.8

131.6 ± 58.5

0.677

0.186

   Male

138.2 ± 68.1

133.8 ± 79.6

0.577

131.6 ± 54.9

121.7 ± 42.2

0.198

0.611

   Female

145.1 ± 54.8

132.2 ± 60.0

0.132

125.9 ± 55.4

142.8 ± 71.9

0.103

0.025*

   HDL (mg/dL)

54.8 ± 12.4

56.4 ± 13.4

0.118

53.7 ± 14.1

54.4 ± 14.1

0.430

0.505

   Male

48.8 ± 9.6

50.4 ± 10.5

0.044*

48.3 ± 10.2

49.2 ± 11.2

0.348

0.604

   Female

60.9 ± 12.1

62.4 ± 13.4

0.404

59.9 ± 15.4

60.3 ± 14.9

0.785

0.635

   LDL (mg/dL)

97.6 ± 31.4

98.6 ± 31.7

0.745

98.9 ± 30.9

99.1 ± 25.6

0.940

0.853

   Male

88.6 ± 30.4

91.0 ± 31.8

0.287

94.4 ± 28.9

92.9 ± 21.2

0.656

0.332

   Female

106.6 ± 30.2

106.2 ± 30.2

0.946

104.1 ± 32.8

106.2 ± 28.5

0.672

0.743

   Total cholesterol (mg/dL)

177.5 ± 38.2

181.1 ± 35.2

0.402

178.0 ± 37.2

179.4 ± 33.7

0.650

0.687

   Male

164.6 ± 31.2

167.6 ± 33.1

0.283

168.5 ± 33.2

166.0 ± 26.3

0.487

0.226

   Female

190.3 ± 40.6

194.5 ± 32.4

0.613

188.7 ± 39.0

194.6 ± 35.1

0.284

0.856

  1. 1 Based on two-sided t test for dependent samples. 2 Based on two-sided t test for independent samples
  2. * Statistical significance was not maintained following Bonferonni correction
  3. In the treatment arm, 33 males and 33 females had biochemical blood measurements at baseline and endpoint.
  4. In the placebo arm, 34 males and 30 females had biochemical blood measurements at baseline and endpoint.
  5. ** In the placebo arm 29 females had BUN measurements at baseline and endpoint.
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BMC Neurology

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