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Dietary Supplement

diabetic patients with NAFLD for Non-alcoholic Fatty Liver Disease

N/A
Recruiting
Led By Timothy R Morgan, MD
Research Sponsored by Southern California Institute for Research and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-75 years
A clinical diagnosis of non-alcoholic fatty liver disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 12 weeks of betaine
Awards & highlights

Summary

This trial will test whether betaine can help people with heart failure.

Who is the study for?
This trial is for adults aged 18-75 with non-alcoholic fatty liver disease, elevated ALT levels (a liver enzyme), and normal platelet counts. They must not have severe liver or kidney issues. Group 1 specifically includes diabetic patients with high fasting blood sugar or HgA1c levels.
What is being tested?
The study tests two different doses of Betaine, a dietary supplement taken orally as a powder mixed in liquid. It aims to see if Betaine can improve liver health in people with fatty liver disease and type 2 diabetes.
What are the potential side effects?
While the side effects are not detailed here, common ones associated with Betaine may include gastrointestinal discomfort like nausea or upset stomach, body odor changes due to its chemical structure similar to choline.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I have been diagnosed with non-alcoholic fatty liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 12 weeks of betaine
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 12 weeks of betaine for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in alanine aminotransferase (ALT) level in all study participants
Secondary study objectives
Compare changes in alanine aminotransferase (ALT) level in both cohorts

Trial Design

2Treatment groups
Active Control
Group I: diabetic patients with NAFLDActive Control1 Intervention
Patients will be prescribed 4 grams of betaine/day (2 grams PO BID) for the first 4 weeks of the study. After 4 weeks, patients in each cohort will be randomized (1:1) to continue receiving betaine 4 grams per day or increase to 8 grams per day for an additional 8 weeks.
Group II: non-diabetics with NAFLDActive Control1 Intervention
Patients will be prescribed 4 grams of betaine/day (2 grams PO BID) for the first 4 weeks of the study. After 4 weeks, patients in each cohort will be randomized (1:1) to continue receiving betaine 4 grams per day or increase to 8 grams per day for an additional 8 weeks.

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Who is running the clinical trial?

Southern California Institute for Research and EducationLead Sponsor
26 Previous Clinical Trials
1,736 Total Patients Enrolled
Timothy R Morgan, MDPrincipal InvestigatorVA Long Beach Healthcare System
1 Previous Clinical Trials
~5 spots leftby Dec 2025
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