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Whole Dairy for Non-alcoholic Fatty Liver Disease

N/A

Recruiting

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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks and 12 weeks to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body Weight Changes

Secondary outcome measures

Body Weight Changes

Change in serum HDL-cholesterol

Change in serum LDL-cholesterol

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm OneExperimental Treatment1 Intervention

Habitual diet for 12 weeks followed by experimental diet for 12 weeks

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,521,024 Total Patients Enrolled

Jeffrey Schwimmer, MDPrincipal InvestigatorUC San Diego

1 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

Whole Dairy Fat (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05499585 — N/A

Liver Disease Research Study Groups: Arm One

Liver Disease Clinical Trial 2023: Whole Dairy Fat Highlights & Side Effects. Trial Name: NCT05499585 — N/A

Whole Dairy Fat (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05499585 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be eligible to join this research project?

"This medical trial seeks 20 pediatric patients with liver diseases such as Nonalcoholic Fatty Liver Disease (NAFLD) and an alanine aminotransferase level of 40 U/L or higher, plus a Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) score of 8% or more. Furthermore, both the participants and their legal guardians must be willing to provide written informed consent."

Answered by AI

Are recruitment processes still ongoing for this research endeavor?

"According to the available information on clinicaltrials.gov, this study is currently recruiting subjects. It was posted online August 1st 2022 and last updated a week later."

Answered by AI

What is the aggregate number of participants involved in this research investigation?

"That is correct. Per the information provided by clinicaltrials.gov, this medical trial commenced on August 1st 2022 and has been actively recruiting ever since then. The study seeks to enrol 20 patients from a single site."

Answered by AI

Is the current clinical trial open to those below the age of 20?

"The lower limit of the age range for eligible participants is set at 10 while the upper boundary is 17, as specified in this trial's enrollment criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treating Pediatric NAFLD With Nutrition

Jeffrey B. Schwimmer, MD 2022. "Treating Pediatric NAFLD With Nutrition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05499585.

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