MedDataX Logo

Efficacy of Nutritional Therapy With High Methionine Content in the Treatment of NAFLD

NCT ID: NCT04450875

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-24

Study Completion Date

2017-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To assess the effect of a methionine metabolism-based dietary strategy in patients with non-alcoholic fatty liver disease in order to reduce complications while improving the quality of life for patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A randomized controlled clinical trial with parallel design was performed, a ratio of at least one patient in the control group for each subject in the experimental group.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-alcoholic Fatty Liver Disease (NAFLD)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Non-alcoholic Fatty Liver Disease Nutrition Therapy Randomized Controlled Trials

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental group: It consisted of a nutritional therapy administration of foods with a high content of methionine according to the National Nutrient Database For Standard Reference (USDA) and adapted to the consumption and usual cost in the Mexican diet. The supervision of the nutritional therapy was carried out through 24-hour reminders, where each patient wrote down the amount and food consumed described in the diet during a 3-month follow-up period. Because the daily requirement for methionine for adults is 260 to 700 mg 98, patients were instructed to combine the foods until they reached a daily intake of at least 700 mg of methionine. Two nutritionists performed both diet instruction and 24-hour reminder monitoring monthly. At the end of the three-month follow-up, the 24-hour reminder data such as food consumed, daily rations, and the monthly average of milligrams of consumed methionine contained in the food, were recorded in a database for subsequent analysis.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Balanced groups are produced on the computer-generated random numbers based on the sex of the study subjects, that is, men and women were proportionally assigned in both groups. An investigator from outside the allocation of exposure generated the random numbers in four blocks: 1) men assigned to the experimental group, 2) women assigned to the experimental group, 3) men assigned to the control group and 4) women assigned to the control group. A second investigator, blindly assigned subjects to experimental and control group. Although concealment of allocation to interest groups could be confirmed, masking of difficulties was not possible once the follow-up began.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group (with diet)

It consisted in the administration of nutritional therapy with foods high in methionine according to the National Nutrient Database For Standard Reference (USDA) and adapted to the consumption and usual cost in the Mexican diet.

Group Type EXPERIMENTAL

Experimental group (with diet)

Intervention Type DIETARY_SUPPLEMENT

Two nutritionists performed both diet instruction and 24-hour reminder monitoring monthly. At the end of the three-month follow-up, the 24-hour reminder data such as food consumed, daily rations, and the monthly average of milligrams of consumed methionine contained in the food, were recorded in a database for subsequent analysis.

Control

The control group continued with their usual diet for the same period of 3 months as the experimental group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Experimental group (with diet)

Two nutritionists performed both diet instruction and 24-hour reminder monitoring monthly. At the end of the three-month follow-up, the 24-hour reminder data such as food consumed, daily rations, and the monthly average of milligrams of consumed methionine contained in the food, were recorded in a database for subsequent analysis.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

• Diagnosis of Non-alcoholic Fatty Liver Disease by biochemical parameters used by the SteatoTest and Fatty Liver Index (IHG), greater than 60 points on the scale and confirmed by liver ultrasound

Exclusion Criteria

• Previous diagnosis of cirrhosis, hepatocarcinoma, Wilson's disease, viral hepatitis B and C and neoplasms of any origin
Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Council of Science and Technology, Mexico

OTHER

Sponsor Role collaborator

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

OTHER_GOV

Sponsor Role collaborator

Universidad Veracruzana

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

María Cristina León

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rebeca García Román, PHD

Role: PRINCIPAL_INVESTIGATOR

UV

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rebeca García Román

Xalapa, Veracruz, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

References

Explore related publications, articles, or registry entries linked to this study.

Zang S, Chen J, Song Y, Bai L, Chen J, Chi X, He F, Sheng H, Wang J, Xie S, Xie W, Yang Y, Zhang J, Zheng M, Zou Z, Wang B, Shi J; Chinese NAFLD Clinical Research Network (CNAFLD CRN). Haptoglobin Genotype and Vitamin E Versus Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis in China: A Multicenter, Randomized, Placebo-Controlled Trial Design. Adv Ther. 2018 Feb;35(2):218-231. doi: 10.1007/s12325-018-0670-8. Epub 2018 Feb 6.

Reference Type BACKGROUND
PMID: 29411270 (View on PubMed)

European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. No abstract available.

Reference Type BACKGROUND
PMID: 27062661 (View on PubMed)

Worm N. Beyond Body Weight-Loss: Dietary Strategies Targeting Intrahepatic Fat in NAFLD. Nutrients. 2020 May 6;12(5):1316. doi: 10.3390/nu12051316.

Reference Type RESULT
PMID: 32384593 (View on PubMed)

Younossi ZM, Stepanova M, Henry L, Racila A, Lam B, Pham HT, Hunt S. A disease-specific quality of life instrument for non-alcoholic fatty liver disease and non-alcoholic steatohepatitis: CLDQ-NAFLD. Liver Int. 2017 Aug;37(8):1209-1218. doi: 10.1111/liv.13391. Epub 2017 Mar 13.

Reference Type RESULT
PMID: 28211165 (View on PubMed)

Rao HY. [Assessment methods and research status of quality of life in patients with nonalcoholic fatty liver disease]. Zhonghua Gan Zang Bing Za Zhi. 2020 Mar 20;28(3):278-283. doi: 10.3760/cma.j.cn50113-20190719-00255. Chinese.

Reference Type RESULT
PMID: 32306665 (View on PubMed)

Anania C, Perla FM, Olivero F, Pacifico L, Chiesa C. Mediterranean diet and nonalcoholic fatty liver disease. World J Gastroenterol. 2018 May 21;24(19):2083-2094. doi: 10.3748/wjg.v24.i19.2083.

Reference Type RESULT
PMID: 29785077 (View on PubMed)

Abenavoli L, Milic N, Peta V, Alfieri F, De Lorenzo A, Bellentani S. Alimentary regimen in non-alcoholic fatty liver disease: Mediterranean diet. World J Gastroenterol. 2014 Dec 7;20(45):16831-40. doi: 10.3748/wjg.v20.i45.16831.

Reference Type RESULT
PMID: 25492997 (View on PubMed)

Chan R, Wong VW, Chu WC, Wong GL, Li LS, Leung J, Chim AM, Yeung DK, Sea MM, Woo J, Chan FK, Chan HL. Diet-Quality Scores and Prevalence of Nonalcoholic Fatty Liver Disease: A Population Study Using Proton-Magnetic Resonance Spectroscopy. PLoS One. 2015 Sep 29;10(9):e0139310. doi: 10.1371/journal.pone.0139310. eCollection 2015.

Reference Type RESULT
PMID: 26418083 (View on PubMed)

Eslamparast T, Eghtesad S, Poustchi H, Hekmatdoost A. Recent advances in dietary supplementation, in treating non-alcoholic fatty liver disease. World J Hepatol. 2015 Feb 27;7(2):204-12. doi: 10.4254/wjh.v7.i2.204.

Reference Type RESULT
PMID: 25729475 (View on PubMed)

Chawla RK, Bonkovsky HL, Galambos JT. Biochemistry and pharmacology of S-adenosyl-L-methionine and rationale for its use in liver disease. Drugs. 1990;40 Suppl 3:98-110. doi: 10.2165/00003495-199000403-00010.

Reference Type RESULT
PMID: 2081485 (View on PubMed)

Lieber CS. Role of S-adenosyl-L-methionine in the treatment of liver diseases. J Hepatol. 1999 Jun;30(6):1155-9. doi: 10.1016/s0168-8278(99)80274-8. No abstract available.

Reference Type RESULT
PMID: 10406198 (View on PubMed)

Mora SI, Garcia-Roman J, Gomez-Nanez I, Garcia-Roman R. Chronic liver diseases and the potential use of S-adenosyl-L-methionine as a hepatoprotector. Eur J Gastroenterol Hepatol. 2018 Aug;30(8):893-900. doi: 10.1097/MEG.0000000000001141.

Reference Type RESULT
PMID: 29683981 (View on PubMed)

Bedogni G, Bellentani S, Miglioli L, Masutti F, Passalacqua M, Castiglione A, Tiribelli C. The Fatty Liver Index: a simple and accurate predictor of hepatic steatosis in the general population. BMC Gastroenterol. 2006 Nov 2;6:33. doi: 10.1186/1471-230X-6-33.

Reference Type RESULT
PMID: 17081293 (View on PubMed)

Zuniga MA, Carrillo-Jimenez GT, Fos PJ, Gandek B, Medina-Moreno MR. [Evaluation of health status using Survey SF-36: preliminary results in Mexico]. Salud Publica Mex. 1999 Mar-Apr;41(2):110-8. Spanish.

Reference Type RESULT
PMID: 10343514 (View on PubMed)

Kobyliak N, Abenavoli L, Mykhalchyshyn G, Kononenko L, Boccuto L, Kyriienko D, Dynnyk O. A Multi-strain Probiotic Reduces the Fatty Liver Index, Cytokines and Aminotransferase levels in NAFLD Patients: Evidence from a Randomized Clinical Trial. J Gastrointestin Liver Dis. 2018 Mar;27(1):41-49. doi: 10.15403/jgld.2014.1121.271.kby.

Reference Type RESULT
PMID: 29557414 (View on PubMed)

Kobyliak N, Abenavoli L, Falalyeyeva T, Mykhalchyshyn G, Boccuto L, Kononenko L, Kyriienko D, Komisarenko I, Dynnyk O. Beneficial effects of probiotic combination with omega-3 fatty acids in NAFLD: a randomized clinical study. Minerva Med. 2018 Dec;109(6):418-428. doi: 10.23736/S0026-4806.18.05845-7. Epub 2018 Sep 13.

Reference Type RESULT
PMID: 30221912 (View on PubMed)

Dong F, Zhang Y, Huang Y, Wang Y, Zhang G, Hu X, Wang J, Chen J, Bao Z. Long-term lifestyle interventions in middle-aged and elderly men with nonalcoholic fatty liver disease: a randomized controlled trial. Sci Rep. 2016 Nov 10;6:36783. doi: 10.1038/srep36783.

Reference Type RESULT
PMID: 27830836 (View on PubMed)

Pervez MA, Khan DA, Ijaz A, Khan S. Effects of Delta-tocotrienol Supplementation on Liver Enzymes, Inflammation, Oxidative stress and Hepatic Steatosis in Patients with Nonalcoholic Fatty Liver Disease. Turk J Gastroenterol. 2018 Mar;29(2):170-176. doi: 10.5152/tjg.2018.17297.

Reference Type RESULT
PMID: 29749323 (View on PubMed)

Aller R, Izaola O, Gomez S, Tafur C, Gonzalez G, Berroa E, Mora N, Gonzalez JM, de Luis DA. Effect of silymarin plus vitamin E in patients with non-alcoholic fatty liver disease. A randomized clinical pilot study. Eur Rev Med Pharmacol Sci. 2015 Aug;19(16):3118-24.

Reference Type RESULT
PMID: 26367736 (View on PubMed)

Ryan MC, Itsiopoulos C, Thodis T, Ward G, Trost N, Hofferberth S, O'Dea K, Desmond PV, Johnson NA, Wilson AM. The Mediterranean diet improves hepatic steatosis and insulin sensitivity in individuals with non-alcoholic fatty liver disease. J Hepatol. 2013 Jul;59(1):138-43. doi: 10.1016/j.jhep.2013.02.012. Epub 2013 Feb 26.

Reference Type RESULT
PMID: 23485520 (View on PubMed)

Capanni M, Calella F, Biagini MR, Genise S, Raimondi L, Bedogni G, Svegliati-Baroni G, Sofi F, Milani S, Abbate R, Surrenti C, Casini A. Prolonged n-3 polyunsaturated fatty acid supplementation ameliorates hepatic steatosis in patients with non-alcoholic fatty liver disease: a pilot study. Aliment Pharmacol Ther. 2006 Apr 15;23(8):1143-51. doi: 10.1111/j.1365-2036.2006.02885.x.

Reference Type RESULT
PMID: 16611275 (View on PubMed)

Spadaro L, Magliocco O, Spampinato D, Piro S, Oliveri C, Alagona C, Papa G, Rabuazzo AM, Purrello F. Effects of n-3 polyunsaturated fatty acids in subjects with nonalcoholic fatty liver disease. Dig Liver Dis. 2008 Mar;40(3):194-9. doi: 10.1016/j.dld.2007.10.003. Epub 2007 Dec 4.

Reference Type RESULT
PMID: 18054848 (View on PubMed)

Zhu FS, Liu S, Chen XM, Huang ZG, Zhang DW. Effects of n-3 polyunsaturated fatty acids from seal oils on nonalcoholic fatty liver disease associated with hyperlipidemia. World J Gastroenterol. 2008 Nov 7;14(41):6395-400. doi: 10.3748/wjg.14.6395.

Reference Type RESULT
PMID: 19009658 (View on PubMed)

Fedewa MV, Nickerson BS, Esco MR. Associations of body adiposity index, waist circumference, and body mass index in young adults. Clin Nutr. 2019 Apr;38(2):715-720. doi: 10.1016/j.clnu.2018.03.014. Epub 2018 Apr 4.

Reference Type RESULT
PMID: 29653863 (View on PubMed)

Gepner Y, Shelef I, Schwarzfuchs D, Zelicha H, Tene L, Yaskolka Meir A, Tsaban G, Cohen N, Bril N, Rein M, Serfaty D, Kenigsbuch S, Komy O, Wolak A, Chassidim Y, Golan R, Avni-Hassid H, Bilitzky A, Sarusi B, Goshen E, Shemesh E, Henkin Y, Stumvoll M, Bluher M, Thiery J, Ceglarek U, Rudich A, Stampfer MJ, Shai I. Effect of Distinct Lifestyle Interventions on Mobilization of Fat Storage Pools: CENTRAL Magnetic Resonance Imaging Randomized Controlled Trial. Circulation. 2018 Mar 13;137(11):1143-1157. doi: 10.1161/CIRCULATIONAHA.117.030501. Epub 2017 Nov 15.

Reference Type RESULT
PMID: 29142011 (View on PubMed)

Fraser A, Abel R, Lawlor DA, Fraser D, Elhayany A. A modified Mediterranean diet is associated with the greatest reduction in alanine aminotransferase levels in obese type 2 diabetes patients: results of a quasi-randomised controlled trial. Diabetologia. 2008 Sep;51(9):1616-22. doi: 10.1007/s00125-008-1049-1. Epub 2008 Jul 3.

Reference Type RESULT
PMID: 18597068 (View on PubMed)

Sanyal AJ, Chalasani N, Kowdley KV, McCullough A, Diehl AM, Bass NM, Neuschwander-Tetri BA, Lavine JE, Tonascia J, Unalp A, Van Natta M, Clark J, Brunt EM, Kleiner DE, Hoofnagle JH, Robuck PR; NASH CRN. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010 May 6;362(18):1675-85. doi: 10.1056/NEJMoa0907929. Epub 2010 Apr 28.

Reference Type RESULT
PMID: 20427778 (View on PubMed)

Harrison SA, Torgerson S, Hayashi P, Ward J, Schenker S. Vitamin E and vitamin C treatment improves fibrosis in patients with nonalcoholic steatohepatitis. Am J Gastroenterol. 2003 Nov;98(11):2485-90. doi: 10.1111/j.1572-0241.2003.08699.x.

Reference Type RESULT
PMID: 14638353 (View on PubMed)

Miller ER 3rd, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005 Jan 4;142(1):37-46. doi: 10.7326/0003-4819-142-1-200501040-00110. Epub 2004 Nov 10.

Reference Type RESULT
PMID: 15537682 (View on PubMed)

Klein EA, Thompson IM Jr, Tangen CM, Crowley JJ, Lucia MS, Goodman PJ, Minasian LM, Ford LG, Parnes HL, Gaziano JM, Karp DD, Lieber MM, Walther PJ, Klotz L, Parsons JK, Chin JL, Darke AK, Lippman SM, Goodman GE, Meyskens FL Jr, Baker LH. Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2011 Oct 12;306(14):1549-56. doi: 10.1001/jama.2011.1437.

Reference Type RESULT
PMID: 21990298 (View on PubMed)

Chachay VS, Macdonald GA, Martin JH, Whitehead JP, O'Moore-Sullivan TM, Lee P, Franklin M, Klein K, Taylor PJ, Ferguson M, Coombes JS, Thomas GP, Cowin GJ, Kirkpatrick CM, Prins JB, Hickman IJ. Resveratrol does not benefit patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2014 Dec;12(12):2092-103.e1-6. doi: 10.1016/j.cgh.2014.02.024. Epub 2014 Feb 25.

Reference Type RESULT
PMID: 24582567 (View on PubMed)

Sayiner M, Stepanova M, Pham H, Noor B, Walters M, Younossi ZM. Assessment of health utilities and quality of life in patients with non-alcoholic fatty liver disease. BMJ Open Gastroenterol. 2016 Aug 16;3(1):e000106. doi: 10.1136/bmjgast-2016-000106. eCollection 2016.

Reference Type RESULT
PMID: 27648297 (View on PubMed)

David K, Kowdley KV, Unalp A, Kanwal F, Brunt EM, Schwimmer JB; NASH CRN Research Group. Quality of life in adults with nonalcoholic fatty liver disease: baseline data from the nonalcoholic steatohepatitis clinical research network. Hepatology. 2009 Jun;49(6):1904-12. doi: 10.1002/hep.22868.

Reference Type RESULT
PMID: 19434741 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

001/060/0194

Identifier Type: OTHER

Identifier Source: secondary_id

ISP-CI-003/2014

Identifier Type: -

Identifier Source: org_study_id