Status:
COMPLETED
Dairy Protien Rich Diet for NAFLD Patients
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Arla Foods
University of Copenhagen
Conditions:
Non-Alcoholic Fatty Liver Disease
Metabolic Syndrome
Eligibility:
All Genders
25-70 years
Phase:
NA
Brief Summary
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 metab...
Detailed Description
To test the hypothesis, state-of-the-art techniques for a comprehensive assessment of liver disease severity and metabolic function will be employed. NAFLD severity and treatment effects will be evalu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Other chronic liver diseases (HBV, HCV, AIH, PBC, PSC, alcoholic steatosis)
- Known systemic disease exempting hypertension and dyslipidemia.
- Former or active malignant disease
- Alcohol consumption \>2 drinks/day for men, 1 drink/day for women, evaluated by AUDIT-C
- Pregnancy
- 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.
- 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
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04841915
Start Date
March 15 2021
End Date
December 1 2023
Last Update
April 1 2025
Active Locations (2)
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1
Aarhus University Hospital, Dept. Hepatology and Gastroenterology
Aarhus N, Denmark, 8200
2
Hvidovre Hospital
Hvidovre, Denmark, 2650