Effects of Alpha-Lipoic Acid Supplementation on Cardiovascular Disease Risk Factors in β-Thalassemia Major Patients: A Clinical Trial Crossover Study

Figures & data

Figure 1 Flowchart of study progress.

Table 1 Baseline Characteristics of All Study Participants at Entry (N= 20)

Variable	Mean ± SD
Age (y)	23.5 ± 5.47
Height (cm)	161.52 ± 13.02
Weight (kg)	55.55 ± 12.22
BMI (kg/m^2)	21.04 ± 2.4
OPG (ng/mL)	4.87 ± 3.04
HCY (µmol/L)	12.12 ± 5.42
Lp-PLA2 (ng/mL)	23.14 ± 8.96
TMAO (pg/mL)	30.42 ± 14.57

Abbreviations: OPG, osteoprotegerin; HCY, homocysteine; Lp-PLA₂, lipoprotein-associated phospholipase A₂; TMAO, trimethylamine N-oxide.

Table 2 Dietary Intakes of Individuals in ALA and Placebo Groups

Variable	ALA Group (N=20)	Placebo Group (N= 20)	P-value
Energy (kcal)	1715.5 ± 296.0	1703.4 ± 271.47	0.724
Protein (g)	69.6 ± 15.8	68.19 ± 22.83	0.774
Carbohydrate (g)	229.5 ± 43.6	240.8 ± 33.6	0.284
Fat (g)	60.2 ± 18.9	54.04 ± 20.91	0.08
Saturated fat (g)	19.4 ± 8.3	17.0 ± 7.77	0.097
MUFA (g)	18.5 ± 7.4	15.9 ± 7.4	0.017*
PUFA (g)	14.6 ± 7.9	14.64 ± 9.06	0.973
Cholesterol (mg)	219.7 ± 30.1	235.42 ± 30.29	0.691
DHA (g)	0.2 ± 0.1	0.11 ± 0.03	0.15
EPA (g)*	0.1 ± 0.1	0.1 ± 0.0	0.092
Calcium (mg)	625.6 ± 52.4	668.9 ± 52.5	0.477
Vitamin E (mg)	2.6 ± 0.5	4.7 ± 1.0	0.037*
Vitamin B6 (mg)	1.2 ± 0.4	1.4 ± 0.5	0.017*
Folate (µg)	236.8 ± 21.3	223.3 ± 25.4	0.645

Notes: Data are presented as Mean  ± SD. P-values are obtained from paired t-test or Wilcoxon signed-rank test*.

Abbreviations: MUFA, monounsaturated fatty acid; PUFA, polyunsaturated fatty acid; DHA, docosahexaenoic acid; EPA, eicosapentaenoic acid.

Table 3 Baseline and End Values of CVD Risk Factors After 8-Wk of ALA Consumption

Variable	All (N= 20)		P-value	Men (N= 13)		P-value	Women (N= 7)		P-value
	ALA Group	Placebo Group		ALA Group	Placebo Group		ALA Group	Placebo Group
OPG
Baseline	5.38 ± 2.79	4.09 ± 2.64	0.096^a	5.24 ± 2.56	5.06 ± 2.54	0.783	5.65 ± 3.39	2.28 ± 1.86	0.069
End point	3.27 ±2.43	4.54 ± 2.89	0.013^b	3.13 ± 2.5	5.03 ± 3.1	0.032	3.54 ± 2.45	3.64 ± 2.41	0.547
P-value^a	0.003	0.411		0.015	0.957		0.122	0.287
HCY
Baseline	12.29 ± 5.55	13.02 ± 5.86	0.303	13.06 ± 4.86	13.37 ± 5.04	0.651	10.85 ± 6.83	12.38 ± 7.56	0.373
End point	11.72 ± 6.92	10.52 ± 7.19	0.329	11.85 ± 6.71	10.47 ± 6.79	0.526	11.47 ± 7.83	10.6 ± 8.44	0.376
P-value	0.665	0.061		0.511	0.126		0.739	0.314
Lp-PLA2
Baseline	24.93 ± 7.61	21.23 ± 9.3	0.076	24.8 ± 5.75	23.73 ± 5.92	0.619	25.18 ± 10.82	16.58 ± 12.84	0.053
End point	22.42 ± 9.94	22.72 ± 9.11	0.311	23.85 ± 8.2	25.37 ± 7.21	0.402	19.76 ± 12.88	17.81 ± 10.76	0.647
P-value	0.186	0453		0.649	0.363		0.18	0.807
TMAO
Baseline	31.66 ± 13.89	27.72 ± 14.29	0.085	31.74 ± 13.4	30.26 ± 10.51	0.526	31.5 ± 15.87	23 ± 19.65	0.093
End point	29.52 ± 12.64	29.54 ± 14.51	0.602	29.37 ± 11.84	30.85 ± 13.17	0.783	29.78 ± 15.02	27.1 ±1 7.59	0.734
P-value	0.418	0.551		0.514	0.855		0.667	0.554

Notes: Data are presented as Mean ± SD. Data were analyzed using ^apaired t-test and ^banalysis of covariance.

Abbreviations: OPG, osteoprotegerin; HCY, homocysteine; Lp-PLA₂, lipoprotein-associated phospholipase A₂; TMAO, trimethylamine N-oxide.

Table 4 Changes of CVD Risk Factors After 8-Wk of ALA Consumption

Variable	ALA Group (N= 20)	Placebo Group (N= 20)	P-value^a	P-value^b
				Group	Time	Time×Group
OPG	−2.11 ± 2.76	0.45 ± 2.42	0.006	0.984	0.058	0.987
Men (N= 13)	−2.11 ± 2.7	−0.03 ± 1.95	0.059	0.263	0.36	0.059
Women (N= 7)	−2.11 ± 3.11	1.35 ± 3.07	0.06	0.093	0.688	0.06
HCY	−0.56 ± 5.79	−2.5 ± 5.63	0.332	0.784	0.078	0.332
Men (N= 13)	−1.2 ±6 .4	−2.9 ± 6.37	0.541	0.669	0.11	0.541
Women (N= 7)	0.61 ± 4.64	−1.77 ± 4.28	0.413	0.715	0.582	0.413
Lp-PLA2	−2.51 ± 8.19	1.49 ± 8.73	0.145	0.252	0.712	0.145
Men (N= 13)	−0.95 ± 7.35	1.63 ± 6.24	0.272	0.903	0.825	0.272
Women (N= 7)	−5.41 ± 9.44	1.2 3 ±12.79	0.347	0.081	0.472	0.347
TMAO	−2.14 ± 11.56	1.82 ± 13.43	0.335	0.387	0.936	0.335
Men (N= 13)	−2.36 ± 12.72	0.59 ± 11.45	0.583	0.999	0.678	0.583
Women (N= 7)	−1.71 ± 10.04	4.1 ± 17.32	0.402	0.349	0.789	0.402

Notes: Data were analyzed using ^apaired t-test and ^brepeated measures analysis of variance.

Abbreviations: OPG, osteoprotegerin; HCY, homocysteine; Lp-PLA₂, lipoprotein-associated phospholipase A₂; TMAO, trimethylamine N-oxide.