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Effects of Fructose Restriction on Liver Steatosis (FRUITLESS)

Primary Purpose

Nonalcoholic Fatty Liver Disease, Glucose Metabolism Disorders, Endothelial Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Glucose
Fructose
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nonalcoholic Fatty Liver Disease focused on measuring Fructose, Diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Body mass index ≥ 28 kg/m2
  • Fatty liver index ≥ 60
  • Fructose intake ≥45 grams/day

Exclusion Criteria:

  • Medical history of liver disease
  • (History of) excessive alcohol consumption (defined as > 2 units/day for women, and > 3 units/day for men)
  • Major change in weight and/or physical activity prior to the study
  • Use of glucose lowering drugs
  • Recent illness
  • Pregnancy and/or lactation
  • Contraindications for magnetic resonance imaging
  • Inability to give informed consent

Protocol change (implemented on July 18, 2018): in order to increase the inclusion of study participants, subjects with an average daily fructose intake < 45 gram/day will also be eligible for participation. In subjects who have an average daily fructose intake < 45 gram/day, supplementation of either fructose or glucose (see 'Arms and Interventions') will be increased to 45 gram/day.

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Glucose

Fructose

Arm Description

Participants will follow a six-week low fructose diet. The amount of restricted fructose will be supplemented as glucose powder.

Participants will follow a six-week low fructose diet. The amount of restricted fructose will be supplemented as fructose powder.

Outcomes

Primary Outcome Measures

Change in intrahepatic triglyceride content
Assessed by magnetic resonance spectroscopy

Secondary Outcome Measures

Change in arterial stiffness (PWV)
Assessed by pulse wave velocity
Change in endothelial function (flowmotion and skin heating response)
Assessed by laser doppler flowmetry
Change in endothelial function (RHI)
Assessed by reactive hyperemia peripheral arterial tonometry
Change in endothelial function (panel of endothelial dysfunction biomarkers)
Assessed by plasma biomarkers
Change in glucose metabolism
Assessed by a standard 75-gram oral glucose tolerance test

Full Information

First Posted
February 21, 2017
Last Updated
February 20, 2020
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03067428
Brief Title
Effects of Fructose Restriction on Liver Steatosis
Acronym
FRUITLESS
Official Title
Effects of Fructose Restriction on Liver Steatosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

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
Nonalcoholic fatty liver disease (NAFLD) is an emerging health problem as it can lead to end stage liver failure and cardiovascular complications. Diet play an important role in the development of NAFLD. Many studies have addressed the effects of added fructose on NAFLD. To date, little attention has been paid to the effects of a diet devoid of fructose. Therefore, the investigators aim to study the effects of fructose restriction on hepatic fat accumulation and vascular function using a double-blind randomized placebo-controlled design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease, Glucose Metabolism Disorders, Endothelial Dysfunction
Keywords
Fructose, Diet

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blind, randomized controlled trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose
Arm Type
Active Comparator
Arm Description
Participants will follow a six-week low fructose diet. The amount of restricted fructose will be supplemented as glucose powder.
Arm Title
Fructose
Arm Type
Placebo Comparator
Arm Description
Participants will follow a six-week low fructose diet. The amount of restricted fructose will be supplemented as fructose powder.
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose
Intervention Description
Participants will adhere to a fructose restricted diet for a period of six weeks (<7.5 grams/meal and/or <10 grams/day; ad-libitum intake). In addition, the amount of fructose that will be restricted - which is based on the average individual fructose intake assessed prior to randomization - will be supplemented as glucose powder three times daily during the meal.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fructose
Intervention Description
Participants will adhere to a fructose restricted diet for a period of six weeks (<7.5 grams/meal and/or <10 grams/day; ad-libitum intake). In addition, the amount of fructose that will be restricted - which is based on the average individual fructose intake assessed prior to randomization - will be supplemented as fructose powder three times daily during the meal.
Primary Outcome Measure Information:
Title
Change in intrahepatic triglyceride content
Description
Assessed by magnetic resonance spectroscopy
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in arterial stiffness (PWV)
Description
Assessed by pulse wave velocity
Time Frame
6 weeks
Title
Change in endothelial function (flowmotion and skin heating response)
Description
Assessed by laser doppler flowmetry
Time Frame
6 weeks
Title
Change in endothelial function (RHI)
Description
Assessed by reactive hyperemia peripheral arterial tonometry
Time Frame
6 weeks
Title
Change in endothelial function (panel of endothelial dysfunction biomarkers)
Description
Assessed by plasma biomarkers
Time Frame
6 weeks
Title
Change in glucose metabolism
Description
Assessed by a standard 75-gram oral glucose tolerance test
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Body mass index ≥ 28 kg/m2 Fatty liver index ≥ 60 Fructose intake ≥45 grams/day Exclusion Criteria: Medical history of liver disease (History of) excessive alcohol consumption (defined as > 2 units/day for women, and > 3 units/day for men) Major change in weight and/or physical activity prior to the study Use of glucose lowering drugs Recent illness Pregnancy and/or lactation Contraindications for magnetic resonance imaging Inability to give informed consent Protocol change (implemented on July 18, 2018): in order to increase the inclusion of study participants, subjects with an average daily fructose intake < 45 gram/day will also be eligible for participation. In subjects who have an average daily fructose intake < 45 gram/day, supplementation of either fructose or glucose (see 'Arms and Interventions') will be increased to 45 gram/day.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martijn CG Brouwers, MD,PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6200 MD
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36184254
Citation
Janssen LEF, Simons N, Simons PIHG, Schaper NC, Feskens EJM, van der Ploeg LMC, Van den Eynde MDG, Schalkwijk CG, Houben AJHM, Stehouwer CDA, Brouwers MCGJ. Effects of fructose restriction on blood pressure: Secondary analysis of a double-blind randomized controlled trial. Clin Nutr ESPEN. 2022 Oct;51:97-103. doi: 10.1016/j.clnesp.2022.07.009. Epub 2022 Jul 30.
Results Reference
derived
PubMed Identifier
33381794
Citation
Simons N, Veeraiah P, Simons PIHG, Schaper NC, Kooi ME, Schrauwen-Hinderling VB, Feskens EJM, van der Ploeg EMCL, Van den Eynde MDG, Schalkwijk CG, Stehouwer CDA, Brouwers MCGJ. Effects of fructose restriction on liver steatosis (FRUITLESS); a double-blind randomized controlled trial. Am J Clin Nutr. 2021 Feb 2;113(2):391-400. doi: 10.1093/ajcn/nqaa332.
Results Reference
derived

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Effects of Fructose Restriction on Liver Steatosis

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