Effects of Fructose Restriction on Liver Steatosis

Endothelial Dysfunction Clinical Trial

— FRUITLESS  

Official title:

Effects of Fructose Restriction on Liver Steatosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067428
• Other study ID #: 162034
• Status: Completed
• Phase: N/A
• Start date: January 31, 2017
• Est. completion date: December 20, 2019

Study information

• Verified date: February 2020
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Fatty Liver
• Glucose Metabolism Disorders
• Liver Diseases
• Metabolic Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Glucose
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.
• Fructose
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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intrahepatic triglyceride content	Assessed by magnetic resonance spectroscopy	6 weeks
Secondary	Change in arterial stiffness (PWV)	Assessed by pulse wave velocity	6 weeks
Secondary	Change in endothelial function (flowmotion and skin heating response)	Assessed by laser doppler flowmetry	6 weeks
Secondary	Change in endothelial function (RHI)	Assessed by reactive hyperemia peripheral arterial tonometry	6 weeks
Secondary	Change in endothelial function (panel of endothelial dysfunction biomarkers)	Assessed by plasma biomarkers	6 weeks
Secondary	Change in glucose metabolism	Assessed by a standard 75-gram oral glucose tolerance test	6 weeks