Grape seed extract in combination with deferasirox ameliorates iron overload, oxidative stress, inflammation, and liver dysfunction in beta thalassemia children.

2023-11
Complementary therapies in clinical practice 53
- Sayeh Mottaghi
- Hassan Abbaszadeh

PubMed: 37832335
DOI: 10.1016/j.ctcp.2023.101804

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 30
Population: β-thalassemia major (β-TM) pediatric patients receiving deferasirox as a standard iron-chelation therapy
Methods: randomly allocated to either GSE group (n = 30) or control group (n = 30) to receive GSE (100 mg/day) or placebo capsules, respectively, for 4 weeks
Blinding: Double-blind
Duration: 4 weeks

Background and purpose

Iron overload in the body is associated with serious and irreversible tissue damage. This study aimed to investigate the iron-chelating, antioxidant, anti-inflammatory, and hepatoprotective activities of grape seed extract (GSE) supplement as well as its safety in β-thalassemia major (β-TM) pediatric patients receiving deferasirox as a standard iron-chelation therapy.

Materials and methods

The children were randomly allocated to either GSE group (n = 30) or control group (n = 30) to receive GSE (100 mg/day) or placebo capsules, respectively, for 4 weeks. The serum levels of iron, ferritin, total iron-binding capacity (TIBC), alanine transaminase (ALT), aspartate aminotransferase (AST), tumor necrosis factor alpha (TNF-α), high-sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA), and glutathione (GSH) as well as superoxide dismutase (SOD) activity and hemoglobin (Hb) concentration were measured pre-and post-intervention.

Results

GSE supplement significantly attenuated the serum levels of iron (p = 0.030), ferritin (p = 0.017), ALT (p = 0.000), AST (p = 0.000), TNF-α (p = 0.000), and hs-CRP (p = 0.001). The TIBC level (p = 0.020) significantly enhanced in the GSE group compared with the placebo group. Moreover, GSE supplement remarkably improved the oxidative stress markers, MDA (p = 0.000) and GSH (p = 0.001). The changes in the SOD activity (p = 0.590) and Hb concentration (p = 0.670) were not statistically different between the groups.

Conclusion

GSE supplement possesses several health beneficial influences on children with β-TM by alleviating iron burden, oxidative stress, inflammation, and liver dysfunction.

Research Insights

Red Grape→Improved Glutathione Level
GSE supplement remarkably improved the oxidative stress markers ... GSH (p = 0.001)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Red Grape→Improved Iron Levels
GSE supplement significantly attenuated the serum levels of iron (p = 0.030)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Red Grape→Improved Superoxide Dismutase Activity
The changes in the SOD activity (p = 0.590) ... were not statistically different between the groups.
Effect
Neutral
Effect size
Small
Dose
100 mg/day
Red Grape→Increased Hemoglobin Levels
The changes in the ... Hb concentration (p = 0.670) were not statistically different between the groups.
Effect
Neutral
Effect size
Small
Dose
100 mg/day
Red Grape→Increased Total Iron Binding Capacity
The TIBC level (p = 0.020) significantly enhanced in the GSE group compared with the placebo group.
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Red Grape→Reduced Alanine Transaminase Level
GSE supplement significantly attenuated the serum levels of ... ALT (p = 0.000)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Red Grape→Reduced Aspartate Aminotransferase Levels
GSE supplement significantly attenuated the serum levels of ... AST (p = 0.000)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Red Grape→Reduced Ferritin Level
GSE supplement significantly attenuated the serum levels of ... ferritin (p = 0.017)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Red Grape→Reduced High-Sensitivity C-Reactive Protein Level
GSE supplement significantly attenuated the serum levels of ... hs-CRP (p = 0.001)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Red Grape→Reduced Malondialdehyde Level
GSE supplement remarkably improved the oxidative stress markers, MDA (p = 0.000)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day
Red Grape→Reduced Tumor Necrosis Factor Alpha
GSE supplement significantly attenuated the serum levels of ... TNF-α (p = 0.000)
Effect
Beneficial
Effect size
Small
Dose
100 mg/day

Adverse Events Reported

Red Grape→Overall tolerability
The study aimed to investigate the iron-chelating, antioxidant, anti-inflammatory, and hepatoprotective activities of grape seed extract (GSE) supplement as well as its safety in β-thalassemia major (β-TM) pediatric patients receiving deferasirox as a standard iron-chelation therapy.
Finding
Reported