Effect of Alpha Lipoic Acid on Non-alcoholic Fatty Liver Diseases

NCT04475276 | Completed Phase 4

• 1 other identifier: T/IM-F/19-20/16
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In developed counties Non-alcoholic fatty liver disease (NAFLD) becomes the most common cause of chronic liver disease , but its prevalence in developing countries like India is also increasing (10 -20%).Till date, there is no US-FDA approved therapy for NAFLD but drugs like metformin, pioglitazone, sitagliptin, vildagliptin Vitamin E, silymarin, statins and ezetimibe have been studied along with life style modification. Life style modifications is the current modality of treatment of NAFLD. All the above-mentioned drugs have some beneficial effects with limited use due to its adverse effects in patients of NAFLD and the study results are non-conclusive. In this scenario, a safe hepatoprotective drug to be evaluated in NAFLD.Alpha-lipoic acid (ALA) or 6,8-thioctic acid, is an endogenous molecule which functions as an important co-factor for various enzyme complexes in mitochondria and plays an important role in energy metabolism. ALA is a nutraceutical agent which also has hepatoprotective and anti-inflammatory effects.ALA is a nutraceutic having anti-inflammatory and antioxidant effects and also increasing insulin sensitivity with lesser adverse effects. The relative scarcity of a promising therapy and non-conclusiveness of the previous studies open up an arena of further research using a nutraceutic in non-diabetic NAFLD. So, the present study is designed to evaluate safety and efficacy of ALA in non-diabetic NAFLD patients.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Non alcoholic fatty liver; Alphalipoic acid; Nutraceutic; Insulin resistance; Cytokeratin 18; Life style modification; Vitamin E

Outcome Measures

Primary Outcomes (1)

• Abdominal ultrasound

  the change in fatty liver grading in NAFLD assessed by abdominal ultrasound

  12 weeks

Secondary Outcomes (12)

• Insulin resistance

  12 weeks

• Lipid profile

  12 weeks

• Levels of glutathione reductase

  12 weeks

• levels of Cytokeratin-18

  12 weeks

• Levels of Alanine transaminase (ALT)

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Life style modification with the placebo will be given for 12 weeks

Drug: Placebo

Alphalipoic acid

EXPERIMENTAL

Life style modification with Alpha lipoic acid in a dose of 600mg twice daily will be prescribed orally for 12 weeks

Drug: Alphalipoic acid

Interventions

Placebo DRUG

Lifestyle modification with placebo for 12 weeks

Placebo

Alphalipoic acid DRUG

Lifestyle modification with Alphalipoic acid for 12 weeks

Alphalipoic acid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients diagnosed to have fatty liver grading 1, 2, 3 on abdominal ultrasound, mild to moderate elevation (\<5 times elevated upper limit) of serum aminotransferase level.
• Patients aged 18-65 years of either sex.

You may not qualify if:

• History of diabetes mellitus, decompensated liver disease, ascites, oesophageal varices.
• Drug abusers and Alcoholics.
• HBs Ag positive, Anti HCV and HIV, hereditary defects of iron, copper and alpha- 1 antitrypsin deficient patients.
• Hypothyroidism, obstructive sleep apnoea, total parenteral nutrition, short bowel syndrome, pancreatoduodenal resection which are secondary causes of NAFLD.
• Drug users such as corticosteroids, antiviral (nucleoside analogue), tetracycline, methotrexate, tamoxifen and amiodarone.
• Patients who are taking any antihyperlipidemic and anti-diabetic agents.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

AIIMS

Bhubaneswar, Odisha, 751019, India

Location

Related Publications (14)

• Hussain M, Majeed Babar MZ, Hussain MS, Akhtar L. Vildagliptin ameliorates biochemical, metabolic and fatty changes associated with non alcoholic fatty liver disease. Pak J Med Sci. 2016 Nov-Dec;32(6):1396-1401. doi: 10.12669/pjms.326.11133.

  PMID: 28083033 BACKGROUND

• Patel SS, Siddiqui MS. Current and Emerging Therapies for Non-alcoholic Fatty Liver Disease. Drugs. 2019 Jan;79(1):75-84. doi: 10.1007/s40265-018-1040-1.

  PMID: 30588564 BACKGROUND

• Cavestro C, Bedogni G, Molinari F, Mandrino S, Rota E, Frigeri MC. Alpha-Lipoic Acid Shows Promise to Improve Migraine in Patients with Insulin Resistance: A 6-Month Exploratory Study. J Med Food. 2018 Mar;21(3):269-273. doi: 10.1089/jmf.2017.0068. Epub 2017 Oct 4.

  PMID: 28976801 BACKGROUND

• Fayez AM, Zakaria S, Moustafa D. Alpha lipoic acid exerts antioxidant effect via Nrf2/HO-1 pathway activation and suppresses hepatic stellate cells activation induced by methotrexate in rats. Biomed Pharmacother. 2018 Sep;105:428-433. doi: 10.1016/j.biopha.2018.05.145. Epub 2018 Jun 5.

  PMID: 29879626 BACKGROUND

• Sadek KM, Saleh EA, Nasr SM. Molecular hepatoprotective effects of lipoic acid against carbon tetrachloride-induced liver fibrosis in rats: Hepatoprotection at molecular level. Hum Exp Toxicol. 2018 Feb;37(2):142-154. doi: 10.1177/0960327117693066. Epub 2017 Feb 21.

  PMID: 29233029 BACKGROUND

• Singh SP, Misra B, Kar SK, Panigrahi MK, Misra D, Bhuyan P, Pattnaik K, Meher C, Agrawal O, Rout N, Swain M. Nonalcoholic fatty liver disease (NAFLD) without insulin resistance: Is it different? Clin Res Hepatol Gastroenterol. 2015 Sep;39(4):482-8. doi: 10.1016/j.clinre.2014.08.014. Epub 2014 Dec 17.

  PMID: 25543522 BACKGROUND

• Ahuja S, Uniyal A, Akhtar A, Sah SP. Alpha lipoic acid and metformin alleviates experimentally induced insulin resistance and cognitive deficit by modulation of TLR2 signalling. Pharmacol Rep. 2019 Aug;71(4):614-623. doi: 10.1016/j.pharep.2019.02.016. Epub 2019 Feb 23.

  PMID: 31176103 BACKGROUND

• He L, Deng L, Zhang Q, Guo J, Zhou J, Song W, Yuan F. Diagnostic Value of CK-18, FGF-21, and Related Biomarker Panel in Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis. Biomed Res Int. 2017;2017:9729107. doi: 10.1155/2017/9729107. Epub 2017 Feb 23.

  PMID: 28326329 BACKGROUND

• Tomic D, Kemp WW, Roberts SK. Nonalcoholic fatty liver disease: current concepts, epidemiology and management strategies. Eur J Gastroenterol Hepatol. 2018 Oct;30(10):1103-1115. doi: 10.1097/MEG.0000000000001235.

  PMID: 30113367 BACKGROUND

• Wu G, Li H, Fang Q, Zhang J, Zhang M, Zhang L, Wu L, Hou X, Lu J, Bao Y, Jia W. Complementary Role of Fibroblast Growth Factor 21 and Cytokeratin 18 in Monitoring the Different Stages of Nonalcoholic Fatty Liver Disease. Sci Rep. 2017 Jul 11;7(1):5095. doi: 10.1038/s41598-017-05257-5.

  PMID: 28698650 BACKGROUND

• Schurks M, Glynn RJ, Rist PM, Tzourio C, Kurth T. Effects of vitamin E on stroke subtypes: meta-analysis of randomised controlled trials. BMJ. 2010 Nov 4;341:c5702. doi: 10.1136/bmj.c5702.

  PMID: 21051774 BACKGROUND

• Dulai PS, Singh S, Patel J, Soni M, Prokop LJ, Younossi Z, Sebastiani G, Ekstedt M, Hagstrom H, Nasr P, Stal P, Wong VW, Kechagias S, Hultcrantz R, Loomba R. Increased risk of mortality by fibrosis stage in nonalcoholic fatty liver disease: Systematic review and meta-analysis. Hepatology. 2017 May;65(5):1557-1565. doi: 10.1002/hep.29085. Epub 2017 Mar 31.

  PMID: 28130788 BACKGROUND

• Khalaf AA, Zaki AR, Galal MK, Ogaly HA, Ibrahim MA, Hassan A. The potential protective effect of alpha-lipoic acid against nanocopper particle-induced hepatotoxicity in male rats. Hum Exp Toxicol. 2017 Sep;36(9):881-891. doi: 10.1177/0960327116674526. Epub 2016 Nov 12.

  PMID: 27827802 BACKGROUND

• Abdel-Daim MM, Taha R, Ghazy EW, El-Sayed YS. Synergistic ameliorative effects of sesame oil and alpha-lipoic acid against subacute diazinon toxicity in rats: hematological, biochemical, and antioxidant studies. Can J Physiol Pharmacol. 2016 Jan;94(1):81-8. doi: 10.1139/cjpp-2015-0131. Epub 2015 Jul 19.

  PMID: 26550680 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Insulin Resistance

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rituparna Maiti, MD

  Additional Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The patients and the physician will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A randomized, parallel design placebo-controlled clinical trial

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 17, 2020
• Study Start: February 23, 2021
• Primary Completion: December 31, 2023
• Study Completion: January 1, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)