NCT05499585Completed
Treating Pediatric NAFLD with Nutrition
Source: ClinicalTrials.gov · Last updated 26 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 10 Aug 2022
- Start date
- 12 Sept 2022
- Primary completion date
- 15 Aug 2024
- Lead sponsor
- University of California, San Diego
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05499585
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 12 Sept 2022 to the primary completion date, 15 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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
- Participant with a history of conditions affecting digestion and/or absorption
- Intervention
- Cow's milk protein allergy
Lab values
- LDL-cholesterol \> 160 mg/dL
Other
- Inability or refusal to consume dairy
- Lactose intolerance
Who the study is looking for
- 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
Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UC San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.