RecruitingNot ApplicableNCT03073343

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

A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) and Elevated Alanine Aminotransferase (ALT)


Sponsor

Southern California Institute for Research and Education

Enrollment

48 participants

Start Date

Nov 12, 2013

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests two different doses of an oral supplement called betaine to see if it can reduce liver inflammation and improve liver health in people with non-alcoholic fatty liver disease (NAFLD) — a condition where too much fat builds up in the liver, often linked to obesity, insulin resistance, or diabetes. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with non-alcoholic fatty liver disease (fatty liver not caused by alcohol) - Your liver enzyme levels (ALT) are elevated (60 IU/mL or above) - You have type 2 diabetes or insulin resistance (pre-diabetes with high fasting blood sugar and insulin resistance) - Your blood counts, kidney function, and bilirubin are within acceptable ranges **You may NOT be eligible if...** - Your liver disease is caused by something other than fatty liver (e.g., hepatitis B or C, autoimmune hepatitis) - You drink more than 1 drink per day (women) or 2 drinks per day (men) regularly - You have used injectable insulin - You are HIV positive or have poorly controlled diabetes (HbA1c above 10%) - You have significant heart failure (Class 2–4) - You are pregnant or breastfeeding - You have a known deficiency in a specific enzyme (CBS deficiency) or are allergic to betaine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTBetaine (trimethyglycine)

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.


Locations(1)

VA Long Beach Healthcare System

Long Beach, California, United States

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NCT03073343


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