Effects of Fructose Restriction on Liver Steatosis

Not Applicable

Completed

• Conditions: Glucose Metabolism Disorders; Nonalcoholic Fatty Liver Disease; Endothelial Dysfunction
• Interventions: Dietary Supplement: Glucose; Dietary Supplement: Fructose

• Registration Number: NCT03067428
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-31
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-03-01
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in intrahepatic triglyceride content	6 weeks	Assessed by magnetic resonance spectroscopy

Secondary Outcome Measures

Name	Time	Method
Change in arterial stiffness (PWV)	6 weeks	Assessed by pulse wave velocity
Change in endothelial function (RHI)	6 weeks	Assessed by reactive hyperemia peripheral arterial tonometry
Change in endothelial function (panel of endothelial dysfunction biomarkers)	6 weeks	Assessed by plasma biomarkers
Change in endothelial function (flowmotion and skin heating response)	6 weeks	Assessed by laser doppler flowmetry
Change in glucose metabolism	6 weeks	Assessed by a standard 75-gram oral glucose tolerance test

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands