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

Abstract

Aim

Thalassemia is one of the most common genetic diseases, and cardiovascular disease (CVD) has been considered as the leading cause of mortality in more than 50% of β-thalassemia patients. The aim of this study was to determine the effects of alpha-lipoic acid (ALA) on CVD risk factors in β-thalassemia major patients.

Methods

Twenty β-thalassemia major patients participated in this randomized crossover clinical trial study. Participants were randomly assigned to ALA (600 mg/day) or placebo groups for two 8-wk interventions that were separated by a 3-wk washout period. The CVD risk factors including serum osteoprotegerin (OPG), homocysteine, lipoprotein-associated phospholipase A₂ and trimethylamine N-oxide were measured at the beginning and the end of each intervention phase according to the standard protocol.

Results

Serum OPG reduced significantly in the ALA group in all participants (5.38 ± 2.79 to 3.27 ± 2.43 ng/mL, P= .003) and in the male subgroup (5.24 ± 2.56 to 3.13 ± 2.5 ng/mL, P= .015); this reduction was significant in comparison with the placebo group (P= .013). The changes in other CVD risk factors were not significant.

Conclusion

The results of this study showed that after 8-wk of ALA consumption, the serum OPG reduced significantly in β-thalassemia major patients. Therefore, controlling the serum OPG level with ALA consumption can be an important complementary therapeutic option to prevent the progression of CVD in β-thalassemia major patients.

Keywords:

• β-thalassemia major
• alpha-lipoic acid
• CVD risk factors

Acknowledgments

This study was extracted from an MSc dissertation which was approved by School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences with the code number 97212. We hereby express our gratitude to all the staff working in the Mohammad Kermanshahi Hospital in the city of Kermanshah and the participants for their cooperation.

Abbreviations

ALA, alpha-lipoic acid; CVD, cardiovascular disease; OPG, osteoprotegerin; HCY, homocysteine; Lp-PLA₂, lipoprotein-associated phospholipase A₂; TMAO, trimethylamine N-oxide; BMI, body mass index; ELISA, enzyme-linked immunosorbent assay; ANCOVA, analysis of covariance; MUFA, monounsaturated fatty acids; TNF-α, tumor necrosis factor-α; RCT, randomized clinical trials; CRP, C-reactive protein; IL-6, interleukin-6; LDL, low-density lipoprotein; LysoPC, lysophosphatidylcholine; OxNEFA, oxidized nonesterified free fatty acids; Ox-LDL, oxidized-LDL; CAD, coronary artery disease; FMO3, flavin-containing monooxygenase-3.

Registration Number

This study was approved by the research deputy of Kermanshah University of Medical Sciences (Code No: IR.KUMS.REC.1397.192) and registered in the Iranian Clinical Trials Registry (registration number IRCT2017061714237N2).

Data Sharing Statement

The data sets used during the current study are available from the corresponding author on reasonable request.

Disclosure

The authors declare that they have no conflict of interest.

Additional information

Funding

This study was funded by the Vice-Chancellor of Research in Kermanshah University of Medical Sciences.