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Nonalcoholic Fatty Liver Disease
+2

Effects of Fructose Restriction on Liver Steatosis

Sponsored by Maastricht University Medical Center

About this trial

Last updated 5 years ago

Study ID

162034

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 6 years ago

What is this trial 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.

What are the participation requirements?

Yes

Inclusion Criteria

- Age ≥ 18 years

- Body mass index ≥ 28 kg/m2

- Fatty liver index ≥ 60

- Fructose intake ≥45 grams/day

No

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.