Effects of Fructose Restriction on Liver Steatosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-12-20

Brief Summary

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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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Detailed Description

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Conditions

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Nonalcoholic Fatty Liver Disease Glucose Metabolism Disorders Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind, randomized controlled trial

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Glucose

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

Group Type ACTIVE_COMPARATOR

Glucose

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Fructose

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes