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Completed

NCT Number: NCT03067428

Effects of Fructose Restriction on Liver Steatosis

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.

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Key information

Conditions

Nonalcoholic Fatty Liver Disease Digestive System Diseases Endothelial Dysfunction Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6200 MD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glucose

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. Change in intrahepatic triglyceride content

    Time frame: 6 weeks

    Assessed by magnetic resonance spectroscopy

Secondary outcomes

  1. Change in arterial stiffness (PWV)

    Time frame: 6 weeks

    Assessed by pulse wave velocity

  2. Change in endothelial function (flowmotion and skin heating response)

    Time frame: 6 weeks

    Assessed by laser doppler flowmetry

  3. Change in endothelial function (RHI)

    Time frame: 6 weeks

    Assessed by reactive hyperemia peripheral arterial tonometry

  4. Change in endothelial function (panel of endothelial dysfunction biomarkers)

    Time frame: 6 weeks

    Assessed by plasma biomarkers

  5. Change in glucose metabolism

    Time frame: 6 weeks

    Assessed by a standard 75-gram oral glucose tolerance test

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Acronym: FRUITLESS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2017
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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