Comparison of delta-tocotrienol and alpha-tocopherol effects on hepatic steatosis and inflammatory biomarkers in patients with non-alcoholic fatty liver disease: A randomized double-blind active-controlled trial
Objective: We aimed to compare the efficacy of δ-tocotrienol with α-tocopherol in the treatment of patients with non-alcoholic fatty liver disease (NAFLD). Design and interventions: This study was a double-blinded, active-controlled trial. The patients with NAFLD were randomly assigned to receive ei...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2022-11-01
|
| Series: | Complementary Therapies in Medicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0965229922000681 |
| _version_ | 1817998682584252416 |
|---|---|
| author | Muhammad Amjad Pervez Dilshad Ahmed Khan Shakeel Ahmed Mirza Atiq Ur Rehman Slehria Uzma Nisar Mohammad Aamir |
| author_facet | Muhammad Amjad Pervez Dilshad Ahmed Khan Shakeel Ahmed Mirza Atiq Ur Rehman Slehria Uzma Nisar Mohammad Aamir |
| author_sort | Muhammad Amjad Pervez |
| collection | DOAJ |
| description | Objective: We aimed to compare the efficacy of δ-tocotrienol with α-tocopherol in the treatment of patients with non-alcoholic fatty liver disease (NAFLD). Design and interventions: This study was a double-blinded, active-controlled trial. The patients with NAFLD were randomly assigned to receive either δ-tocotrienol 300 mg or α-tocopherol 268 mg twice daily for 48 weeks. Endpoints: The primary endpoints were change from baseline in fatty liver index (FLI), liver-to-spleen attenuation ratio (L/S ratio), and homeostatic model assessment for insulin resistance (HOMA-IR) at 48 weeks. Key secondary endpoints were change in markers of inflammation, oxidative stress, and hepatocyte apoptosis. Clinical assessment, biochemical analysis, and computed tomography scan of the liver were conducted at baseline, 24 and 48 weeks. Results: A total of 100 patients (δ-tocotrienol = 50, α-tocopherol = 50) were randomized and included in the intention to treat analysis. Compared with baseline, there was a significant improvement (p < .001) in FLI, L/S ratio, HOMA-IR, and serum malondialdehyde in both groups at 48 weeks that was not significant between the two groups. However, there was a significantly greater decrease in body weight, serum interleukin-6, tumor necrosis factor-alpha, leptin, cytokeratin-18, and increase in adiponectin in the δ-tocotrienol group compared to the α-tocopherol group at 48 weeks (p < .05). No adverse events were reported. Conclusion: δ-tocotrienol and α-tocopherol exerted equally beneficial effects in terms of improvement in hepatic steatosis, oxidative stress, and insulin resistance in patients with NAFLD. However, δ-tocotrienol was more potent than α-tocopherol in reducing body weight, inflammation, and apoptosis associated with NAFLD. Trial Registration: Sri Lankan Clinical Trials Registry (https://slctr.lk/SLCTR/2019/038). |
| first_indexed | 2024-04-14T02:56:43Z |
| format | Article |
| id | doaj.art-3a43079ba50140f895fafedf744364b3 |
| institution | Directory Open Access Journal |
| issn | 0965-2299 |
| language | English |
| last_indexed | 2024-04-14T02:56:43Z |
| publishDate | 2022-11-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Complementary Therapies in Medicine |
| spelling | doaj.art-3a43079ba50140f895fafedf744364b32022-12-22T02:16:03ZengElsevierComplementary Therapies in Medicine0965-22992022-11-0170102866Comparison of delta-tocotrienol and alpha-tocopherol effects on hepatic steatosis and inflammatory biomarkers in patients with non-alcoholic fatty liver disease: A randomized double-blind active-controlled trialMuhammad Amjad Pervez0Dilshad Ahmed Khan1Shakeel Ahmed Mirza2Atiq Ur Rehman Slehria3Uzma Nisar4Mohammad Aamir5Armed Forces Institute of Pathology, National University of Medical Sciences, Rawalpindi, PakistanArmed Forces Institute of Pathology, National University of Medical Sciences, Rawalpindi, Pakistan; Correspondence to: National University of Medical Sciences, Rawalpindi 46000, Pakistan.Mega Medical Complex Hospital, Rawalpindi, PakistanArmed Forces Institute of Radiology and Imaging, National University of Medical Sciences, Rawalpindi, PakistanArmed Forces Institute of Radiology and Imaging, National University of Medical Sciences, Rawalpindi, PakistanArmed Forces Institute of Pathology, National University of Medical Sciences, Rawalpindi, PakistanObjective: We aimed to compare the efficacy of δ-tocotrienol with α-tocopherol in the treatment of patients with non-alcoholic fatty liver disease (NAFLD). Design and interventions: This study was a double-blinded, active-controlled trial. The patients with NAFLD were randomly assigned to receive either δ-tocotrienol 300 mg or α-tocopherol 268 mg twice daily for 48 weeks. Endpoints: The primary endpoints were change from baseline in fatty liver index (FLI), liver-to-spleen attenuation ratio (L/S ratio), and homeostatic model assessment for insulin resistance (HOMA-IR) at 48 weeks. Key secondary endpoints were change in markers of inflammation, oxidative stress, and hepatocyte apoptosis. Clinical assessment, biochemical analysis, and computed tomography scan of the liver were conducted at baseline, 24 and 48 weeks. Results: A total of 100 patients (δ-tocotrienol = 50, α-tocopherol = 50) were randomized and included in the intention to treat analysis. Compared with baseline, there was a significant improvement (p < .001) in FLI, L/S ratio, HOMA-IR, and serum malondialdehyde in both groups at 48 weeks that was not significant between the two groups. However, there was a significantly greater decrease in body weight, serum interleukin-6, tumor necrosis factor-alpha, leptin, cytokeratin-18, and increase in adiponectin in the δ-tocotrienol group compared to the α-tocopherol group at 48 weeks (p < .05). No adverse events were reported. Conclusion: δ-tocotrienol and α-tocopherol exerted equally beneficial effects in terms of improvement in hepatic steatosis, oxidative stress, and insulin resistance in patients with NAFLD. However, δ-tocotrienol was more potent than α-tocopherol in reducing body weight, inflammation, and apoptosis associated with NAFLD. Trial Registration: Sri Lankan Clinical Trials Registry (https://slctr.lk/SLCTR/2019/038).http://www.sciencedirect.com/science/article/pii/S0965229922000681Non-alcoholic fatty liver diseaseδ-tocotrienolα-tocopherolFatty liver indexLiver-to-spleen attenuation ratioInflammatory biomarkers |
| spellingShingle | Muhammad Amjad Pervez Dilshad Ahmed Khan Shakeel Ahmed Mirza Atiq Ur Rehman Slehria Uzma Nisar Mohammad Aamir Comparison of delta-tocotrienol and alpha-tocopherol effects on hepatic steatosis and inflammatory biomarkers in patients with non-alcoholic fatty liver disease: A randomized double-blind active-controlled trial Complementary Therapies in Medicine Non-alcoholic fatty liver disease δ-tocotrienol α-tocopherol Fatty liver index Liver-to-spleen attenuation ratio Inflammatory biomarkers |
| title | Comparison of delta-tocotrienol and alpha-tocopherol effects on hepatic steatosis and inflammatory biomarkers in patients with non-alcoholic fatty liver disease: A randomized double-blind active-controlled trial |
| title_full | Comparison of delta-tocotrienol and alpha-tocopherol effects on hepatic steatosis and inflammatory biomarkers in patients with non-alcoholic fatty liver disease: A randomized double-blind active-controlled trial |
| title_fullStr | Comparison of delta-tocotrienol and alpha-tocopherol effects on hepatic steatosis and inflammatory biomarkers in patients with non-alcoholic fatty liver disease: A randomized double-blind active-controlled trial |
| title_full_unstemmed | Comparison of delta-tocotrienol and alpha-tocopherol effects on hepatic steatosis and inflammatory biomarkers in patients with non-alcoholic fatty liver disease: A randomized double-blind active-controlled trial |
| title_short | Comparison of delta-tocotrienol and alpha-tocopherol effects on hepatic steatosis and inflammatory biomarkers in patients with non-alcoholic fatty liver disease: A randomized double-blind active-controlled trial |
| title_sort | comparison of delta tocotrienol and alpha tocopherol effects on hepatic steatosis and inflammatory biomarkers in patients with non alcoholic fatty liver disease a randomized double blind active controlled trial |
| topic | Non-alcoholic fatty liver disease δ-tocotrienol α-tocopherol Fatty liver index Liver-to-spleen attenuation ratio Inflammatory biomarkers |
| url | http://www.sciencedirect.com/science/article/pii/S0965229922000681 |
| work_keys_str_mv | AT muhammadamjadpervez comparisonofdeltatocotrienolandalphatocopheroleffectsonhepaticsteatosisandinflammatorybiomarkersinpatientswithnonalcoholicfattyliverdiseasearandomizeddoubleblindactivecontrolledtrial AT dilshadahmedkhan comparisonofdeltatocotrienolandalphatocopheroleffectsonhepaticsteatosisandinflammatorybiomarkersinpatientswithnonalcoholicfattyliverdiseasearandomizeddoubleblindactivecontrolledtrial AT shakeelahmedmirza comparisonofdeltatocotrienolandalphatocopheroleffectsonhepaticsteatosisandinflammatorybiomarkersinpatientswithnonalcoholicfattyliverdiseasearandomizeddoubleblindactivecontrolledtrial AT atiqurrehmanslehria comparisonofdeltatocotrienolandalphatocopheroleffectsonhepaticsteatosisandinflammatorybiomarkersinpatientswithnonalcoholicfattyliverdiseasearandomizeddoubleblindactivecontrolledtrial AT uzmanisar comparisonofdeltatocotrienolandalphatocopheroleffectsonhepaticsteatosisandinflammatorybiomarkersinpatientswithnonalcoholicfattyliverdiseasearandomizeddoubleblindactivecontrolledtrial AT mohammadaamir comparisonofdeltatocotrienolandalphatocopheroleffectsonhepaticsteatosisandinflammatorybiomarkersinpatientswithnonalcoholicfattyliverdiseasearandomizeddoubleblindactivecontrolledtrial |