Clinical trial NCT03067428: Effects of Fructose Restriction on Liver Steatosis
Official title: Effects of Fructose Restriction on Liver Steatosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonalcoholic Fatty Liver Disease
Glucose Metabolism Disorders
Endothelial Dysfunction
Keywords: Fructose
Diet
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind, randomized controlled trial
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Change in intrahepatic triglyceride content
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in arterial stiffness (PWV)
timeFrame: 6 weeks
measure: Change in endothelial function (flowmotion and skin heating response)
timeFrame: 6 weeks
measure: Change in endothelial function (RHI)
timeFrame: 6 weeks
measure: Change in endothelial function (panel of endothelial dysfunction biomarkers)
timeFrame: 6 weeks
measure: Change in glucose metabolism
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Martijn CG Brouwers, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.