NCT03073343 is a NA clinical trial of Betaine (trimethyglycine) in Non-Alcoholic Fatty Liver Disease, sponsored by Southern California Institute for Research and Education.

Who is sponsoring NCT03073343?

NCT03073343 is sponsored by Southern California Institute for Research and Education.

What drugs are being tested in NCT03073343?

Interventions in NCT03073343: Betaine (trimethyglycine).

What condition does NCT03073343 study?

NCT03073343 studies Non-Alcoholic Fatty Liver Disease, Non Insulin Dependent Diabetes, ALT.

Is NCT03073343 still recruiting?

NCT03073343 is currently recruiting now. Last updated 7 May 2024.

Last reviewed 2024-05-07 · How we verify

NCT03073343

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine

Recruiting now NA Last updated 7 May 2024

What this trial tests

NA trial testing Betaine (trimethyglycine) in Non-Alcoholic Fatty Liver Disease in 48 participants. Currently enrolling.

Timeline

12 November 2013

Primary endpoint
30 December 2025

30 December 2025

Quick facts

Lead sponsor	Southern California Institute for Research and Education
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	12 November 2013
Primary completion	30 December 2025
Estimated completion	30 December 2025
Sites	1 location across United States

Drugs / interventions tested

Betaine (trimethyglycine)

Conditions studied

Non-Alcoholic Fatty Liver Disease — all drugs for Non-Alcoholic Fatty Liver Disease →
Non Insulin Dependent Diabetes — all drugs for Non Insulin Dependent Diabetes →
ALT — all drugs for ALT →

Sponsor

Southern California Institute for Research and Education

Who can join

Adults 18 to 75, any sex, with Non-Alcoholic Fatty Liver Disease or Non Insulin Dependent Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Betaine (trimethyglycine) is a food supplement that is approved for sale in the United States without a prescription. In this study, betaine will be provided to patients as a powder that can be mixed with aqueous solutions and consumed orally.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Treatment options for alcoholic and non-alcoholic fatty liver disease: A review.
Singh S, Osna NA, Kharbanda KK. · · 2017 · cited 169× · PMID 29085205 · DOI 10.3748/wjg.v23.i36.6549
Mitochondrial Quality Control: Its Role in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
Shin S, Kim J, Lee JY, Kim J, et al · · 2023 · cited 45× · PMID 38049180 · DOI 10.7570/jomes23054
The Impacts of Herbal Medicines and Natural Products on Regulating the Hepatic Lipid Metabolism.
Li S, Xu Y, Guo W, Chen F, et al · · 2020 · cited 40× · PMID 32265720 · DOI 10.3389/fphar.2020.00351
Addressing the heterogeneity in liver diseases using biological networks.
Lam S, Doran S, Yuksel HH, Altay O, et al · · 2021 · cited 5× · PMID 32201876 · DOI 10.1093/bib/bbaa002
Reactive Oxygen Species as Key Molecules in the Pathogenesis of Alcoholic Fatty Liver Disease and Nonalcoholic Fatty Liver Disease: Future Perspectives.
Zhang Z, Yang H, Han F, Guo P. · · 2025 · cited 3× · PMID 40699863 · DOI 10.3390/cimb47060464
Pilot trials of oral betaine in participants with metabolic dysfunction-associated steatotic liver disease and elevated alanine aminotransferase.
Lim AS, Cruz SN, Uddin AA, Malysheva O, et al · · 2026 · cited 2× · PMID 40758380 · DOI 10.1097/hep.0000000000001477

Verify or expand the search:

Other recruiting trials for Non-Alcoholic Fatty Liver Disease

Currently open trials in the same condition.

NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · recruiting
NCT07294963 — Impact of Lifestyle Interventions on Cognitive Decline in Non-alcoholic Fatty Liver Disease · NA · recruiting
NCT07130318 — Mediterranean Diet in Familial Mediterranean Fever: Is Fatty Liver Affected by Addition of Aerobic Exercise · NA · recruiting
NCT06355310 — Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease · Phase 2 · recruiting
NCT06863376 — Evaluating the Safety and Efficacy of Carbocisteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients · Phase 2 · recruiting

Other Southern California Institute for Research and Education trials

Trials by the same sponsor.

NCT07276204 — Betaine vs. Placebo for Serologically Diagnosed Metabolic Dysfunction-associated Steatohepatitis (MASH) · Phase 2 · not yet recruiting
NCT02871076 — Acupuncture for Post-Traumatic Stress in Combat Veterans · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03073343 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Southern California Institute for Research and Education
Last refreshed: 7 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03073343.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing