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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118310
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hannes Hagström, Karolinska University Hospital

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.

Condition or disease Intervention/treatment Phase
NAFLD Behavioral: 5:2 diet Behavioral: LCHF Behavioral: Placebo diet Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of NAFLD With Two Different Diets
Actual Study Start Date : April 6, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo diet
Behavioral: Placebo diet
Placebo diet: normal dietary advice

Experimental: 5:2
5:2 diet
Behavioral: 5:2 diet
Dietary intervention according to 5:2 diet during three months.

Experimental: LCHF
LCHF diet
Behavioral: LCHF
Dietary intervention according to LCHF diet during three months.




Primary Outcome Measures :
  1. Liver fat [ Time Frame: Three months ]
    MRI-measured liver fat content



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Known NAFLD

Exclusion Criteria:

  • Other forms of liver disease
  • Bolus insulin treatment
  • Cirrhosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118310


Contacts
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Contact: Hannes Hagström, MD, PhD 0046858580000 hannes.hagstrom@ki.se
Contact: Per Stål, MD, ass prof 0046858580000 per.stal@ki.se

Locations
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Sweden
Center for Digestive Diseases, Karolinska University Hospital Recruiting
Stockholm, Sweden, 14186
Contact: Hannes Hagström, MD, PhD    0046858580000    hannes.hagstrom@ki.se   
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Hannes Hagström, MD, PhD Karolinska University Hospital
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Responsible Party: Hannes Hagström, Primary Investigator, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03118310    
Other Study ID Numbers: Dnr 2017/258-31
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hannes Hagström, Karolinska University Hospital:
Reduction of liver fat
Additional relevant MeSH terms:
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Non-alcoholic Fatty Liver Disease
Fatty Liver
Liver Diseases
Digestive System Diseases