Dairy Protien Rich Diet for NAFLD Patients
DAIPRO-NAFLD
A Randomized Controlled Trial of Effects of DAIry PROtein Products on Liver Disease Severity and Metabolism in Patients With Non-Alcoholic Fatty Liver Disease.
1 other identifier
interventional
46
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2021
CompletedFirst Submitted
Initial submission to the registry
March 24, 2021
CompletedFirst Posted
Study publicly available on registry
April 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedApril 1, 2025
April 1, 2023
2.7 years
March 24, 2021
March 26, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Steatosis, absolute
Absolute difference in changes in steatosis (MRs) between diets
4 weeks and 20 weeks
Steatosis, relative
Relative difference in changes in steatosis (MRs) between diets
4 weeks and 20 weeks
Liver enzymes
Difference in change of liver enzymes between diets
4 weeks and 20 weeks
Secondary Outcomes (4)
Hepatic Insulin Resistance
24 weeks
Adipose tissue Insulin Resistance
24 weeks
Peripheral insulin resistance
24 weeks
Insulin Secretion
24 weeks
Other Outcomes (1)
Anthropometric measures
24 weeks
Study Arms (3)
Micellar Cassein Isolate High-Protein Diet
EXPERIMENTAL4weeks eucaloric intake on high-protein diet with micellar cassein as primary protein source followed by 20weeks hypocaloric intake on equivalent protein rich diet.
Whey Protein High-Protein Diet
EXPERIMENTAL4weeks eucaloric intake on high-protein diet with whey protein as primary protein source followed by 20weeks hypocaloric intake on equivalent protein rich diet.
Normal Diet
PLACEBO COMPARATOR4weeks eucaloric diet with normal protein content (15E%) followed by 20weeks hypocaloric intake on equivalent diet.
Interventions
Diet consisting of 25E% from assigned protein during eucaloric diet and 35E% from assigned protein during hypocaloric diet
Counselling from a clinical dietician bi-weekly until weight loss of 5% is achieved.
4 weeks eucaloric diet \~13 MJ/day followed by, 20 weeks hypocaloric diet \~9 MJ/day until 5% weight loss is achieved.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Arla Foodscollaborator
- University of Copenhagencollaborator
- Hvidovre University Hospitalcollaborator
Study Sites (2)
Aarhus University Hospital, Dept. Hepatology and Gastroenterology
Aarhus N, 8200, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henning Grønbæk, Prof.
University of Aarhus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The participants will be randomized to one of 3 treatment arms. Protein interventions (MCI and WPI) will be blinded to participants and investigators, but controls with regular diet will not be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2021
First Posted
April 12, 2021
Study Start
March 15, 2021
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
April 1, 2025
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share