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Treatment of NAFLD With Two Different Diets (TREND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118310
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Hannes Hagström, Karolinska University Hospital

Tracking Information
First Submitted Date  ICMJE April 6, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE April 6, 2017
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
Liver fat [ Time Frame: Three months ]
MRI-measured liver fat content
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of NAFLD With Two Different Diets
Official Title  ICMJE Treatment of NAFLD With Two Different Diets
Brief Summary The impact of popular diets on liver-related health is unclear. In this randomized, controlled trial, patients with NAFLD will be randomized to one of two popular diets or a placebo diet.
Detailed Description Subjects will include patients with MRI-verified NAFLD, with no concurrent liver diseases. Randomization will be done to either a control diet, the 5:2 diet or a low-carb-high-fat diet. The subjects will follow the diet for three months, after which a new MRI is performed. Main outcomes measure is reduction in liver fat.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE NAFLD
Intervention  ICMJE
  • Behavioral: 5:2 diet
    Dietary intervention according to 5:2 diet during three months.
  • Behavioral: LCHF
    Dietary intervention according to LCHF diet during three months.
  • Behavioral: Placebo diet
    Placebo diet: normal dietary advice
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo diet
    Intervention: Behavioral: Placebo diet
  • Experimental: 5:2
    5:2 diet
    Intervention: Behavioral: 5:2 diet
  • Experimental: LCHF
    LCHF diet
    Intervention: Behavioral: LCHF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2020)
74
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2017)
60
Actual Study Completion Date  ICMJE August 31, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Known NAFLD

Exclusion Criteria:

  • Other forms of liver disease
  • Bolus insulin treatment
  • Cirrhosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03118310
Other Study ID Numbers  ICMJE Dnr 2017/258-31
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hannes Hagström, Karolinska University Hospital
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hannes Hagström, MD, PhD Karolinska University Hospital
PRS Account Karolinska University Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP