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Whole Dairy for Non-alcoholic Fatty Liver Disease
N/A
Waitlist Available
Led By Jeffrey Schwimmer, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks and 12 weeks to 24 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is to compare the effects of daily intake of whole dairy fat vs a habitual diet on hepatic steatosis in children with NAFLD.
Who is the study for?
This trial is for children aged 10-17 with Non-alcoholic Fatty Liver Disease (NAFLD) and elevated liver enzymes (ALT ≥ 40 U/L). They must have a certain level of fat in their liver as shown by MRI, be able to consume dairy, and not have other chronic liver diseases, diabetes, high LDL cholesterol or conditions affecting digestion. A legal guardian must consent.
What is being tested?
The study tests if consuming at least 20 grams of whole dairy fat daily can reduce liver fat compared to usual diets in kids with NAFLD. It's designed to see if this nutritional approach could be an effective treatment for fatty liver disease in children.
What are the potential side effects?
Since the intervention involves dietary changes to include whole dairy, potential side effects may include digestive discomfort especially if participants are sensitive to lactose despite not being intolerant. Other specific side effects will depend on individual health responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks and 12 weeks to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks and 12 weeks to 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Body Weight Changes
Secondary study objectives
Body Weight Changes
Change in serum HDL-cholesterol
Change in serum LDL-cholesterol
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm OneExperimental Treatment1 Intervention
Habitual diet for 12 weeks followed by experimental diet for 12 weeks
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,189 Previous Clinical Trials
1,587,688 Total Patients Enrolled
Jeffrey Schwimmer, MDPrincipal InvestigatorUC San Diego
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had or plan to have weight-loss surgery during the study.I have been diagnosed with fatty liver disease.I have diabetes.I am between 10 and 17 years old.I cannot or choose not to consume dairy products.I have a history of digestive or absorption issues.I have a chronic liver condition not caused by alcohol, drugs, or hepatitis C.
Research Study Groups:
This trial has the following groups:- Group 1: Arm One
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.