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Treatment of NAFLD With Two Different Diets (TREND)

Primary Purpose

NAFLD

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
5:2 diet
LCHF
Placebo diet
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD focused on measuring Reduction of liver fat

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Known NAFLD

Exclusion Criteria:

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

Sites / Locations

  • Center for Digestive Diseases, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

5:2

LCHF

Arm Description

Placebo diet

5:2 diet

LCHF diet

Outcomes

Primary Outcome Measures

Liver fat
MRI-measured liver fat content

Secondary Outcome Measures

Full Information

First Posted
April 6, 2017
Last Updated
August 31, 2020
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03118310
Brief Title
Treatment of NAFLD With Two Different Diets
Acronym
TREND
Official Title
Treatment of NAFLD With Two Different Diets
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 6, 2017 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD
Keywords
Reduction of liver fat

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo diet
Arm Title
5:2
Arm Type
Experimental
Arm Description
5:2 diet
Arm Title
LCHF
Arm Type
Experimental
Arm Description
LCHF diet
Intervention Type
Behavioral
Intervention Name(s)
5:2 diet
Intervention Description
Dietary intervention according to 5:2 diet during three months.
Intervention Type
Behavioral
Intervention Name(s)
LCHF
Intervention Description
Dietary intervention according to LCHF diet during three months.
Intervention Type
Behavioral
Intervention Name(s)
Placebo diet
Intervention Description
Placebo diet: normal dietary advice
Primary Outcome Measure Information:
Title
Liver fat
Description
MRI-measured liver fat content
Time Frame
Three months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Known NAFLD Exclusion Criteria: Other forms of liver disease Bolus insulin treatment Cirrhosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannes Hagström, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Digestive Diseases, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33898960
Citation
Holmer M, Lindqvist C, Petersson S, Moshtaghi-Svensson J, Tillander V, Brismar TB, Hagstrom H, Stal P. Treatment of NAFLD with intermittent calorie restriction or low-carb high-fat diet - a randomised controlled trial. JHEP Rep. 2021 Feb 17;3(3):100256. doi: 10.1016/j.jhepr.2021.100256. eCollection 2021 Jun.
Results Reference
derived

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Treatment of NAFLD With Two Different Diets

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