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Clinical Trials/ACTRN12623000756628
ACTRN12623000756628
Recruiting
未知

The comparative effects of a very low energy diet and the mediterranean diet on hepatic and metabolic outcomes in nonalcoholic fatty liver disease: A randomised controlled trial.

St Vincent's Hospital Melboourne0 sites24 target enrollmentJuly 11, 2023
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Conditionsonalcoholic fatty liver diseaseNonalcoholic fatty liver diseaseOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Overview

Phase
未知
Intervention
Not specified
Conditions
onalcoholic fatty liver disease
Sponsor
St Vincent's Hospital Melboourne
Enrollment
24
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 11, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
St Vincent's Hospital Melboourne

Eligibility Criteria

Inclusion Criteria

  • •1\.Individuals aged 18 – 70 who are able to provide consent
  • •2\.BMI 27kg/m2 to 35kg/m2
  • •3\.Elevated ALT and/or GGT
  • •4\.\>\= F1 fibrosis on liver biopsy
  • •5\.Liver fat on MRS \>\= 10%

Exclusion Criteria

  • •1\.Alcohol \>2 SD/day for men and \>1 SD/day for women
  • •2\.Other liver disease, i.e. viral hepatitis, autoimmune liver disease, haemochromatosis
  • •3\.Decompensated cirrhosis or cirrhosis with Fibroscan \> 25kPa
  • •4\.Other significant medical or psychological issue that would preclude a diet; such as cardiac disease, lung disease or malignancy
  • •5\.Antibiotics, probiotics, corticosteroids, hormonal therapies or methotrexate within three months of baseline data collection, or current use of a GLP\-1 agonist or insulin
  • •6\.Already lost \>5% body weight or previous bariatric surgery
  • •7\.Participation in another interventional trial, or participation in another interventional trial within the last 6 months

Outcomes

Primary Outcomes

Not specified

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