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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

Study Description
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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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 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
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


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


Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sweden
Center for Digestive Diseases, Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Hannes Hagström, MD, PhD Karolinska University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: September 2, 2020
Last Verified: August 2020
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