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Table 3 Descriptive statistics for plasma micronutrients, erythrocyte fatty acids and homocysteine following Fortasyn Connect supplementation

From: Effects of Souvenaid on plasma micronutrient levels and fatty acid profiles in mild and mild-to-moderate Alzheimer’s disease

 

Control

Active

p value

 

Baseline

End of study

Baseline

End of study

Uridine (μM)

     

 RCT1 (0–24 wk)

3.91 [1.74, 7.06] (72)

4.04 [1.16, 6.72] (68)

3.99 [1.01, 7.67] (77)

4.63 [1.47, 25.94] (72)

0.044*

 RCT2 (0–24 wk)

3.5 [0.8, 10.6] (129)

3.5 [0.6, 17.3] (119)

3.6 [0.5, 10.3] (128)

8.6 [1.8, 34.9] (116)

<0.001*

 OLE (24–48 wk), C-A, A-A

  

3.5 [0.6, 17.3] (103), 8.8 [1.8, 28.9] (96)

6.6 [1.6, 22.0] (95), 6.6 [1.4, 22.4] (85)

<0.001* (C-A), <0.001* (A-A)

 RCT3 (0–24 wk)

3.6 [0.4, 7.7] (248)

3.2 [0.6, 25.7] (230)

3.6 [1.1, 28.8] (253)

7.4 [1.5, 32.0] (237)

<0.001*

Choline (μM)

     

 RCT1 (0–24 wk)

8.54 [4.30, 19.90] (72)

8.59 [5.44, 16.00] (67)

9.64 [5.21, 22.50] (75)

11.30 [5.92, 28.10] (73)

<0.001*

 RCT2 (0–24 wk)

9.4 [4.4, 18.2] (128)

8.7 [4.5, 18.6] (117)

9.2 [4.5, 18.1] (128)

13.3 [5.8, 28.8] (116)

<0.001*

 OLE (24–48 wk), C-A, A-A

  

8.5 [4.5, 18.6] (101), 12.8 [5.8, 28.8] (96)

14.0 [3.6, 29.4] (91), 14.6 [7.4, 29.2]

<0.001* (C-A), 0.149* (A-A)

Erythrocyte DHA (%)

     

 RCT1 (0–24 wk)

3.6 [0.7, 7.2] (104)

3.6 [2.0-6.9] (74)

3.6 [2.1, 6.5] (103)

7.0 [1.4-9.2] (73)

<0.001**

 RCT2 (0–24 wk)

3.1 [0.0, 5.6] (128)

3.2 [0.7, 6.8] (119)

3.0 [0.3, 5.9] (129)

6.7 [1.3, 8.7] (114)

<0.001*

 OLE (24–48 wk), C-A, A-A

  

3.4 [0.7, 5.8] (103), 6.7 [1.3, 8.7] (94)

6.9 [0.4, 9.1] (93), 6.8 [1.1, 10.8] (87)

<0.001* (C-A), 0.853* (A-A)

 RCT3 (0–24 wk)

2.4 [0.0, 6.5] (257)

2.4 [0.2, 4.9] (232)

2.4 [0.0, 8.1] (259)

6.6 [0.9, 10.1] (239)

<0.001

Erythrocyte EPA (%)

     

 RCT1 (0–24 wk)

0.9 [0.1, 3.4] (104)

0.9 [0.1, 3.6] (74)

1.0 [0.1, 2.8] (103)

1.8 [0.0, 3.1] (73)

<0.001**

 RCT2 (0–24 wk)

0.8 [0.0, 3.3] (128)

0.8 [0.2, 2.7] (119)

0.8 [0.0, 2.9] (129)

1.6 [0.3, 4.0] (114)

<0.001*

 OLE (24–48 wk), C-A, A-A

  

0.8 [0.3, 2.7] (103), 1.6 [0.6, 4.0] (94)

1.7 [0.1, 4.8] (93), 1.6 [0.5, 3.6] (87)

<0.001* (C-A), 0.730* (A-A)

 RCT3 (0–24 wk)

0.4 [0.0, 3.6] (257)

0.5 [0.0, 2.0] (232)

0.4 [0.0, 2.6] (259)

1.2 [0.0, 4.3] (239)

<0.001

Plasma DHA (%)

     

 RCT1 (0–24 wk)

1.8 [0.8, 4.9] (91)

1.9 [1.0, 5.4] (54)

1.9 [0.8, 6.2](91)

3.8 [1.2, 6.6](66)

<0.001**

 RCT2 (0–24 wk)

1.7 [0.7, 3.4] (129)

1.6 [0.6, 3.4] (119)

1.7 [0.7, 4.3] (129)

4.7 [1.3, 7.7] (115)

<0.001

 OLE (24–48 wk), C-A, A-A

  

1.6 [0.8, 3.4] (103), 4.7 [1.3, 7.7] (95)

4.9 [1.1, 7.2] (95), 4.9 [1.4, 9.4] (87)

<0.001* (C-A), 0.357* (A-A)

Plasma EPA (%)

     

 RCT1 (0–24 wk)

0.8 [0.2, 4.0] (91)

0.8 [0.4, 3.4] (54)

0.8 [0.2, 2.9] (91)

1.4 [0.4, 3.8] (66)]

<0.001**

 RCT2 (0–24 wk)

0.8 [0.2, 3.9] (129)

0.7 [0.0, 2.8] (119)

0.8 [0.3, 4.5] (129)

1.7 [0.4, 4.9] (115)

<0.001*

 OLE (24–48 wk), C-A, A-A

  

0.7 [0.0, 2.8] (103), 1.7 [0.4, 4.9] (95)

1.9 [0.4, 5.4] (95), 1.7 [0.4, 5.0] (87)

<0.001* (C-A), 0.688* (A-A)

Folate (nM)

     

 RCT1 (0–24 wk)

15.04 [0.31, 66.70] (71)

16.45 [2.91, 154.8] (63)

14.55 [2.85, 68.46] (76)

44.40 [14.02, 182.0] (66)

<0.001*

 RCT2 (0–24 wk)

12.6 [2.4, 45.3] (129)

13.5 [2.7, 45.3] (119)

12.3 [3.6, 45.3] (128)

37.3 [12.2, 45.3] (115)

<0.001*

 OLE (24–48 wk), C-A, A-A

  

13.5 [4.8, 45.3] (103), 37.3 [12.2, 45.3] (95)

37.2 [16.2, 83.4] (95), 39.4 [6.4, 77.1] (87)

<0.001* (C-A), 0.405* (A-A)

Vitamin B12 (pM)

     

 RCT1 (0–24 wk)

282.0 [71.0, 971.0] (71)

266.5 [68.0, 1265.0] (66)

250.0 [87.0, 676.0] (75)

311.0 [97.0, 856.0] (71)

<0.001*

 RCT2 (0–24 wk)

300.0 [90, 1476] (129)

308.0 [156, 1476] (119)

289.5 [127, 1476] (128)

322.0 [177, 1476] (116)

<0.001*

 OLE (24–48 wk), C-A, A-A

  

310.0 [163, 1476] (103), 323.0 [117, 1476] (96)

328.0 [166, 1476] (95), 312.0 [154, 1476] (87)

0.030* (C-A), <0.001* (A-A)

Vitamin B6 (nM)

     

 RCT2 (0–24 wk)

45.6 [11.5, 182.3] (45)

42.6 [9.4, 128.0] (41)

37.2 [13.5, 257.2] (37)

59.5 [27.1, 377.4] (36)

<0.001*

 OLE (24–48 wk), C-A, A-A

  

43.0 [12.9, 128.0] (38), 60.3 [27.1, 377.4] (33)

84.9 [44.8, 173.8] (17), 76.8 [33.0, 121.9] (13)

<0.001* (C-A), 0.244* (A-A)

Vitamin E (μM)

     

 RCT1 (0–24 wk)

31.9 [12.3, 66.2] (104)

30.9 [14.3, 78.5] (74)

33.1 [19.2, 75.2] (104)

39.6 [13.1, 83.6] (74)

<0.001**

 RCT2 (0–24 wk)

32.0 [9.2, 70.6] (129)

33.2 [14.4, 61.6] (119)

32.1 [18.0, 71.4] (129)

41.6 [25.7, 73.6] (116)

<0.001*

 OLE (24–48 wk), C-A, A-A

  

32.8 [14.4, 61.6] (103), 41.7 [25.7, 73.6] (96)

40.2 [20.7, 72.4] (93), 41.5 [20.1, 68.6] (88)

<0.001* (C-A), 0.319* (A-A)

 RCT3 (0–24 wk)

29.9 [8.5, 99.8] (255)

30.6 [6.0, 78.4] (233)

29.6 [1.8, 84.3] (260)

38.5 [17.1, 109.4] (239)

<0.001

Selenium (μM)

     

 RCT1 (0–24 wk)

1.1 [0.6-1.8] (73)

1.0 [0.6-1.5] (68)

1.1 [0.6, 2.1] (75)

1.3 [0.7, 2.0] (72)

<0.001**

 RCT2 (0–24 wk)

1.1 [0.3, 1.6] (129)

1.1 [0.5, 1.8] (119)

1.1 [0.6, 1.9] (129)

1.4 [0.7, 2.0] (116)

<0.001*

 OLE (24–48 wk), C-A, A-A

  

1.1 [0.5, 1.8] (103), 1.4 [0.7, 2.0] (96)

1.3 [0.8, 1.7] (15), 1.3 [1.1, 1.5] (15)

0.007* (C-A), 0.017* (A-A)

Homocysteine (μM)

     

 RCT1 (0–24 wk)

11.7 [5.0, 83.0] (104)

12.0 [6.8, 42.1] (74)

12.5 [6.6, 36.7] (104)

9.7 [4.0, 19.1] (74)

<0.001**

 RCT2 (0–24 wk)

11.7 [3.9, 28.3] (129)

13.4 [3.3, 38.8] (119)

12.1 [4.4, 37.3] (129)

10.5 [2.3, 20.3] (116)

<0.001*

 OLE (24–48 wk), C-A, A-A

  

13.9 [3.3, 38.8] (103), 10.3 [2.3, 20.3] (96)

9.2 [4.7, 17.1] (93), 9.3 [4.3, 19.0] (86)

<0.001* (C-A), <0.001* (A-A)

 RCT3 (0–24 wk)

10.6 [3.9, 100.5] (256)

11.0 [3.5, 102.5] (234)

10.4 [12.8, 50.5] (260)

9.8 [2.0, 46.1] (239)

0.004*

  1. A-A active-active, C-A control-active; DHA docosahexaenoic acid; EPA eicosapentaenoic acid; OLE open-label extension; RCT randomized clinical trial
  2. Data are median [min, max] (n) for all parameters and RCTs to present comparable data
  3. *Mann–Whitney U test, change from baseline at week 24, control vs. active (RCT1, RCT2 and RCT3); Wilcoxon signed-rank test, 24 weeks vs. 48 weeks within control-active (C-A) and active-active (A-A) group (OLE)
  4. **Independent samples t test, change from baseline at week 24, control vs. active
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Alzheimer's Research & Therapy

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