Non-Alcoholic Fatty Liver DiseaseNCT05499585
Treating Pediatric NAFLD with Nutrition
A study testing Whole Dairy in people with Non-Alcoholic Fatty Liver Disease and Liver Diseases, run by University of California, San Diego at 1 site in United States.
Trial summary
This is a proof of concept clinical trial to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Liver Diseases, Liver Fat
- What is being tested?
- Whole Dairy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2022to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 10 through 17 years
- NAFLD
- ALT of ≥ 40 U/L
- MRI-PDFF ≥ 8%
- Ability and willingness of legal guardian and participant to provide written, informed consent
Who cannot join
- Competing Health Conditions
- Participants with a history of health issues that make it unsafe for them to participate in the opinion of the investigator
- Type 1 or Type 2 Diabetes
- LDL-cholesterol > 160 mg/dL
- Evidence of other chronic liver disease (alcohol liver disease, alcohol related liver disease, hepatitis C, chronic hepatotoxic drug use, mitochondrial diseases, autoimmune liver disease, wilson's disease)
- History of bariatric surgery or planning to undergo bariatric surgery during the study duration
Show all 11Show fewer
- Participant with a history of conditions affecting digestion and/or absorption
- Intervention
- Inability or refusal to consume dairy
- Cow's milk protein allergy
- Lactose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
This is a proof of concept clinical trial to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD.
Read the detailed description
Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in children, estimated to be present in 5-10% of all children in the United States. NAFLD is a growing cause of cirrhosis and liver cancer. There is not yet an FDA approved treatment for NAFLD. Guidelines recommend improvement in diet at the first line of treatment; however, there is no consensus as to what that diet should be. General health guidelines recommend nonfat or low fat dairy over whole dairy after age 2. Limited studies have suggested that whole dairy may be better for people with NAFLD.
This study will test the effect of whole dairy on liver fat in children age 10-17 with NAFLD. As a baseline, the investigators will measure liver fat (using MRI) at 2 time points separated by 12 weeks to establish the current amount of liver fat. The children will be instructed to incorporate 2 ½ servings of whole dairy (as milk and/or yogurt provided by the study will provide) into their daily diet. After 12 weeks, the investigators will measure liver fat with MR and labs to assess safety and further evaluate the liver.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Liver Diseases, Liver Fat, Hepatic Steatosis, Nutritional and Metabolic Disease
- Being tested
- Whole Dairy
- Keywords
- child, adolescent, nutrition, liver
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases, Fatty Liver, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole DairyOther
2 1/2 servings of whole dairy per day
| Study group | Role | What they receive |
|---|---|---|
| Arm One | Other | Habitual diet for 12 weeks followed by experimental diet for 12 weeks Receives: Other: Whole Dairy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatic steatosis measured by liver MRI-PDFF
The primary outcome for the 24 week study is to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD
Measured: Baseline to 12 weeks and 12 weeks to 24 weeks
Secondary outcomes (10)
Change in serum alanine transaminase (ALT)
ALT will be measured and compared
Measured: Baseline, week 12 and week 24
Change in serum aspartate transaminase (AST)
AST will be measured and compared
Measured: Baseline, week 12 and week 24
Change in serum gamma-glutamyl transpeptidase (GGT)
GGT will be measured and compared
Measured: Baseline, week 12 and week 24
Change in serum total cholesterol
Serum total cholesterol will be measured and compared
Measured: Baseline, week 12 and week 24
Change in serum LDL-cholesterol
Serum LDL-cholesterol will be measured and compared
Measured: Baseline, week 12 and week 24
Change in serum HDL-cholesterol
Serum HDL-cholesterol will be measured and compared
Measured: Baseline, week 12 and week 24
Change in serum triglycerides
Serum triglycerides will be measured and compared
Measured: Baseline, week 12 and week 24
Change in plasma fatty acid levels
Plasma fatty acid levels will be measured and compared
Measured: Baseline, week 12 and week 24
Change in subcutaneous adipose tissue (SCAT)
SCAT will be measured and compared
Measured: Baseline, week 12 and week 24
Change in visceral adipose tissue (VAT)
VAT will be measured and compared
Measured: Baseline, week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start12 Sep 2022
- Primary completion15 Aug 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey B. Schwimmer, MD, University of California, San Diego
- Investigators
- Jeffrey Schwimmer, MD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499585
- Sponsor's protocol ID
- 803602
- Status last verified
- Sep 2024
- First submitted
- 10 Aug 2022
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Pediatric NAFLD with Nutrition
- ClinicalTrials.gov ID
- NCT05499585
- Acronym / sponsor ID
- 803602
- Conditions
- Non-Alcoholic Fatty Liver Disease, Liver Diseases, Liver Fat, Hepatic Steatosis, Nutritional and Metabolic Disease
- Keywords
- child, adolescent, nutrition, liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a proof of concept clinical trial to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD.
Detailed description
Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in children, estimated to be present in 5-10% of all children in the United States. NAFLD is a growing cause of cirrhosis and liver cancer. There is not yet an FDA approved treatment for NAFLD. Guidelines recommend improvement in diet at the first line of treatment; however, there is no consensus as to what that diet should be. General health guidelines recommend nonfat or low fat dairy over whole dairy after age 2. Limited studies have suggested that whole dairy may be better for people with NAFLD.
This study will test the effect of whole dairy on liver fat in children age 10-17 with NAFLD. As a baseline, the investigators will measure liver fat (using MRI) at 2 time points separated by 12 weeks to establish the current amount of liver fat. The children will be instructed to incorporate 2 ½ servings of whole dairy (as milk and/or yogurt provided by the study will provide) into their daily diet. After 12 weeks, the investigators will measure liver fat with MR and labs to assess safety and further evaluate the liver.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm One | Other | Other: Whole DairyHabitual diet for 12 weeks followed by experimental diet for 12 weeks |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 10 through 17 years
- NAFLD
- ALT of ≥ 40 U/L
- MRI-PDFF ≥ 8%
- Ability and willingness of legal guardian and participant to provide written, informed consent
Key exclusion criteria (11 listed)
- Competing Health Conditions
- Participants with a history of health issues that make it unsafe for them to participate in the opinion of the investigator
- Type 1 or Type 2 Diabetes
- LDL-cholesterol > 160 mg/dL
- Evidence of other chronic liver disease (alcohol liver disease, alcohol related liver disease, hepatitis C, chronic hepatotoxic drug use, mitochondrial diseases, autoimmune liver disease, wilson's disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Dairy2 1/2 servings of whole dairy per day | Other | Arm One |
Primary outcome
Change in hepatic steatosis measured by liver MRI-PDFF
Time frame: Baseline to 12 weeks and 12 weeks to 24 weeks
The primary outcome for the 24 week study is to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD
10 secondary outcomes
Change in serum alanine transaminase (ALT)
Time frame: Baseline, week 12 and week 24
Change in serum aspartate transaminase (AST)
Time frame: Baseline, week 12 and week 24
Change in serum gamma-glutamyl transpeptidase (GGT)
Time frame: Baseline, week 12 and week 24
Change in serum total cholesterol
Time frame: Baseline, week 12 and week 24
Change in serum LDL-cholesterol
Time frame: Baseline, week 12 and week 24
Change in serum HDL-cholesterol
Time frame: Baseline, week 12 and week 24
Change in serum triglycerides
Time frame: Baseline, week 12 and week 24
Change in plasma fatty acid levels
Time frame: Baseline, week 12 and week 24
Change in subcutaneous adipose tissue (SCAT)
Time frame: Baseline, week 12 and week 24
Change in visceral adipose tissue (VAT)
Time frame: Baseline, week 12 and week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Schwimmer, MD principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Dairy in people with Non-Alcoholic Fatty Liver Disease and Liver Diseases, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hepatic steatosis measured by liver MRI-PDFF (time frame: Baseline to 12 weeks and 12 weeks to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.