Impact Of Choline in Patients With NAFLD

NCT05200156 | Unknown

• 1 other identifier: Choline in NAFLD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be assessing the impact of choline supplementation in Non-alcoholic fatty liver disease patients using ultrasonography to show change in liver echogenicity, various laboratory tests as liver function, lipid profile and glucose control tests and finally on markers of oxidative stress as Thiobarbituric acid reactive substances and Leptin.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Choline and Leptin/Thiobarbituric acid reactive substances

Outcome Measures

Primary Outcomes (1)

• effect on Oxidative stress marker as the mean change of Thiobarbituric acid reactive substances level

  Measured as the mean change in Thiobarbituric acid reactive substances serum level (mmol/μg) at baseline and after 12 weeks of choline supplementation

  12 weeks

Secondary Outcomes (1)

• effect on Inflammatory status as the mean change in leptin levels

  12 weeks

Other Outcomes (2)

• Clinical outcome as measured by Hepatic ultrasonography

  12 weeks

• Clinical outcome as measured by Hepatic US

  12 weeks

Study Arms (2)

Choline supplement group

EXPERIMENTAL

Phosphatidyl choline tablets at a dose of 1200 mg twice per day plus conventional management for 12 weeks

Dietary Supplement: Phosphatidyl Choline

Control group

NO INTERVENTION

conventional management only for 12 weeks

Interventions

Phosphatidyl Choline DIETARY_SUPPLEMENT

conventional management + phosphatidyl choline tablets

Choline supplement group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Patients from 18 to 65 years.
• Gender: both males and females (age and sex matched in both groups).
• Patients diagnosed with NAFLD via ultrasound (hepatic steatosis observation on ultrasound).
• Treatment free from choline supplementation for the past 3 months prior starting the therapeutic regimen.

You may not qualify if:

• Other liver diseases as viral hepatitis (B or C)
• Alcohol consumption more than 40 g per week for the past 12 months, and life-time cumulative consumption more than 100 kg.
• Autoimmune liver disease
• Malignancy of any nature.
• Any systemic failure (cardiovascular, renal or respiratory)
• Patients with major psychiatric illness.
• Pregnant or lactating women.
• Diabetes mellitus .

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Tropical Medicine Department

Cairo, Egypt

RECRUITING

Related Publications (17)

• Lockman KA, Baren JP, Pemberton CJ, Baghdadi H, Burgess KE, Plevris-Papaioannou N, Lee P, Howie F, Beckett G, Pryde A, Jaap AJ, Hayes PC, Filippi C, Plevris JN. Oxidative stress rather than triglyceride accumulation is a determinant of mitochondrial dysfunction in in vitro models of hepatic cellular steatosis. Liver Int. 2012 Aug;32(7):1079-92. doi: 10.1111/j.1478-3231.2012.02775.x. Epub 2012 Mar 19.

  PMID: 22429485 BACKGROUND

• Bahrami M, Cheraghpour M, Jafarirad S, Alavinejad P, Asadi F, Hekmatdoost A, Mohammadi M, Yari Z. The effect of melatonin on treatment of patients with non-alcoholic fatty liver disease: a randomized double blind clinical trial. Complement Ther Med. 2020 Aug;52:102452. doi: 10.1016/j.ctim.2020.102452. Epub 2020 May 23.

  PMID: 32951715 BACKGROUND

• Buchman AL. The addition of choline to parenteral nutrition. Gastroenterology. 2009 Nov;137(5 Suppl):S119-28. doi: 10.1053/j.gastro.2009.08.010.

  PMID: 19874943 BACKGROUND

• Canbakan B, Tahan V, Balci H, Hatemi I, Erer B, Ozbay G, Sut N, Hacibekiroglu M, Imeryuz N, Senturk H. Leptin in nonalcoholic fatty liver disease. Ann Hepatol. 2008 Jul-Sep;7(3):249-54.

  PMID: 18753993 BACKGROUND

• Corbin KD, Zeisel SH. Choline metabolism provides novel insights into nonalcoholic fatty liver disease and its progression. Curr Opin Gastroenterol. 2012 Mar;28(2):159-65. doi: 10.1097/MOG.0b013e32834e7b4b.

  PMID: 22134222 BACKGROUND

• Guo WX, Pye QN, Williamson KS, Stewart CA, Hensley KL, Kotake Y, Floyd RA, Broyles RH. Mitochondrial dysfunction in choline deficiency-induced apoptosis in cultured rat hepatocytes. Free Radic Biol Med. 2005 Sep 1;39(5):641-50. doi: 10.1016/j.freeradbiomed.2005.04.013.

  PMID: 16085182 BACKGROUND

• Hassan K, Bhalla V, El Regal ME, A-Kader HH. Nonalcoholic fatty liver disease: a comprehensive review of a growing epidemic. World J Gastroenterol. 2014 Sep 14;20(34):12082-101. doi: 10.3748/wjg.v20.i34.12082.

  PMID: 25232245 BACKGROUND

• Lee JH, Kim D, Kim HJ, Lee CH, Yang JI, Kim W, Kim YJ, Yoon JH, Cho SH, Sung MW, Lee HS. Hepatic steatosis index: a simple screening tool reflecting nonalcoholic fatty liver disease. Dig Liver Dis. 2010 Jul;42(7):503-8. doi: 10.1016/j.dld.2009.08.002. Epub 2009 Sep 18.

  PMID: 19766548 BACKGROUND

• Madan K, Bhardwaj P, Thareja S, Gupta SD, Saraya A. Oxidant stress and antioxidant status among patients with nonalcoholic fatty liver disease (NAFLD). J Clin Gastroenterol. 2006 Nov-Dec;40(10):930-5. doi: 10.1097/01.mcg.0000212608.59090.08.

  PMID: 17063114 BACKGROUND

• Mishra A, Younossi ZM. Epidemiology and Natural History of Non-alcoholic Fatty Liver Disease. J Clin Exp Hepatol. 2012 Jun;2(2):135-44. doi: 10.1016/S0973-6883(12)60102-9. Epub 2012 Jul 21.

  PMID: 25755422 BACKGROUND

• Mirza MS. Obesity, Visceral Fat, and NAFLD: Querying the Role of Adipokines in the Progression of Nonalcoholic Fatty Liver Disease. ISRN Gastroenterol. 2011;2011:592404. doi: 10.5402/2011/592404. Epub 2011 Aug 28.

  PMID: 21991518 BACKGROUND

• Polyzos SA, Kountouras J, Mantzoros CS. Leptin in nonalcoholic fatty liver disease: a narrative review. Metabolism. 2015 Jan;64(1):60-78. doi: 10.1016/j.metabol.2014.10.012. Epub 2014 Oct 23.

  PMID: 25456097 BACKGROUND

• Sanyal AJ, Campbell-Sargent C, Mirshahi F, Rizzo WB, Contos MJ, Sterling RK, Luketic VA, Shiffman ML, Clore JN. Nonalcoholic steatohepatitis: association of insulin resistance and mitochondrial abnormalities. Gastroenterology. 2001 Apr;120(5):1183-92. doi: 10.1053/gast.2001.23256.

  PMID: 11266382 BACKGROUND

• Yesilova Z, Yaman H, Oktenli C, Ozcan A, Uygun A, Cakir E, Sanisoglu SY, Erdil A, Ates Y, Aslan M, Musabak U, Erbil MK, Karaeren N, Dagalp K. Systemic markers of lipid peroxidation and antioxidants in patients with nonalcoholic Fatty liver disease. Am J Gastroenterol. 2005 Apr;100(4):850-5. doi: 10.1111/j.1572-0241.2005.41500.x.

  PMID: 15784031 BACKGROUND

• Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, George J, Bugianesi E. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018 Jan;15(1):11-20. doi: 10.1038/nrgastro.2017.109. Epub 2017 Sep 20.

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• Zeisel SH. Choline: critical role during fetal development and dietary requirements in adults. Annu Rev Nutr. 2006;26:229-50. doi: 10.1146/annurev.nutr.26.061505.111156.

  PMID: 16848706 BACKGROUND

• Sedhom SS, El Wakeel LM, Barakat EMF, Shousha HI, Shamkh MA, Salama SH, Zaky DZ, El Kholy AA. The impact of choline supplementation on oxidative stress and clinical outcomes among patients with non-alcoholic fatty liver disease: a randomized controlled study. Ther Adv Chronic Dis. 2025 Aug 17;16:20406223251358659. doi: 10.1177/20406223251358659. eCollection 2025.

  PMID: 40838115 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Phosphatidylcholines

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids

Study Officials

• Lamia El Wakeel, PhD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Doaa Zakaria, PhD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amal El Kholy, PhD

CONTACT

201060355448; amalanas9@gmail.com

Sylvia Samir Fouad, Master's

CONTACT

201227919053; dr_sylvia_samir@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Model Details: The study is a Prospective, Randomized, Controlled, single blinded study.

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: January 20, 2022
• Study Start: February 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: February 1, 2024
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)