Effects of Fructose Restriction on Liver Steatosis (FRUITLESS)

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Nonalcoholic Fatty Liver Disease; Endothelial Dysfunction; Glucose Metabolism Disorders

Treatments: Dietary Supplement: Glucose; Dietary Supplement: Fructose

Study type: Interventional

Funder types: Other

Identifiers

NCT03067428

162034

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

Glucose

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Glucose

Fructose

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Fructose