RecruitingNot Applicable

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

United States48 participantsStarted 2013-11-12

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age 18-75 years
✓. A clinical diagnosis of non-alcoholic fatty liver disease.
✓. Alanine aminotransferase (ALT) levels ≥60 IU/mL
✓. Laboratory tests as defined below:

Exclusion criteria

✕. Evidence of liver disease other than non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
✕. Alcohol consumption of more than 12g/d (1 drink) for females or more than 24g/day (2 drinks) for males, for 3 months during the past year
✕. Active substance abuse within the past year
✕. Prior or ongoing use of injectable insulin
✕. Use of oral corticosteroids within the prior 30 days
✕. Hospitalization within the past 14 days
✕. Known HIV infection
✕. HgA1c \>10%

What they're measuring

Change in alanine aminotransferase (ALT) level in all study participants

Timeframe: after 12 weeks of Betaine

Trial details

NCT IDNCT03073343

SponsorSouthern California Institute for Research and Education

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-30

Contact for this trial

Timothy R Morgan, MD

562-826-5212 timothy.morgan@va.gov

View on ClinicalTrials.gov More Non-Alcoholic Fatty Liver Disease trials