NCT04841915Completed
Dairy Protien Rich Diet for NAFLD Patients
A Randomized Controlled Trial of Effects of DAIry PROtein Products on Liver Disease Severity and Metabolism in Patients With Non-Alcoholic Fatty Liver Disease.
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
The overarching aim of this project is to investigate effects of dietary interventions on nonalcoholic fatty liver disease (NAFLD) severity and to delineate the relationship with improvements in metabolic aberrations in liver-, fat- and muscle tissue, using a panel of state-of-the art techniques. The investigators will conduct a randomized clinical trial with three arms to investigate if micellar cassein isolate and whey protein supplementation as part of a high-protein diet during 4 weeks of weight maintenance and 20 weeks of hypocaloric intake (30% energy restriction) inducing modest weight loss (5% of baseline weight) has beneficial effects on NAFLD severity and metabolic aberrations compared to normal diet in NAFLD patients. It is hypothesized that: (i) a high-protein diet improves liver disease severity and metabolic function compared to a normal protein diet; (ii) Cassein provides greater benefits than whey; and(iii) these effects manifest during both weight maintenance and weight loss.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 24 Mar 2021
- Start date
- 15 Mar 2021
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- University of Aarhus
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04841915
What you commit to
- Study type: Interventional
- Participants enrolled: 46
- From 15 Mar 2021 to the primary completion date, 1 Dec 2023
- 2 sites 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
- Other chronic liver diseases (HBV, HCV, AIH, PBC, PSC, alcoholic steatosis)
- Known systemic disease exempting hypertension and dyslipidemia.
- Former or active malignant disease
- Any medications including non-prescription medications exempting, birth control medications, antihypertensives and statins. Participants taking statins can participate on the condition of a 2 week pause before the experimental days.
Other
- Alcohol consumption \>2 drinks/day for men, 1 drink/day for women, evaluated by AUDIT-C
- Pregnancy
- Estimated glomerular filtration rate \<90 ml/min
- Currently smoking
- Blood donation within the last 3 months
- Weight above 130 kg
- Participated in trials using radioactive isotopes within the last 6 months
Who the study is looking for
- BMI ≥ 27.5 kg/m2
- HbA1C \< 48 mmol/mol
- Written informed consent
- Liver steatosis \> 10% on MR-spectroscopy
- Premenopausal women will have a negative pregnancy test drawn within 48 hours before the study.
Age in the registry: 25 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital, Dept. Hepatology and Gastroenterology Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
| Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.