Dairy Protien Rich Diet for NAFLD Patients

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.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Metabolic Syndrome
• Caseins
• Whey
• Diet, High Protein
• Weight Loss
• Lipoproteins, VLDL

Interventions

DIETARY_SUPPLEMENT

High-Protein Diet

Diet consisting of 25E% from assigned protein during eucaloric diet and 35E% from assigned protein during hypocaloric diet

BEHAVIORAL

Clinical dietician

Counselling from a clinical dietician bi-weekly until weight loss of 5% is achieved.

BEHAVIORAL

Weight loss

4 weeks eucaloric diet \~13 MJ/day followed by, 20 weeks hypocaloric diet \~9 MJ/day until 5% weight loss is achieved.

Sponsors & Collaborators

• Arla Foods

  collaborator INDUSTRY

• University of Copenhagen

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Henning Grønbæk, Prof. · University of Aarhus

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-15

Primary Completion

2023-12-01

Completion

2023-12-01

Countries

• Denmark

Study Locations