Effects of Fructose Restriction on Liver Steatosis

NCT03067428 | Completed

• 1 other identifier: 162034
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver Disease; Glucose Metabolism Disorders; Endothelial Dysfunction

Keywords

Fructose; Diet

Outcome Measures

Primary Outcomes (1)

• Change in intrahepatic triglyceride content

  Assessed by magnetic resonance spectroscopy

  6 weeks

Secondary Outcomes (5)

• Change in arterial stiffness (PWV)

  6 weeks

• Change in endothelial function (flowmotion and skin heating response)

  6 weeks

• Change in endothelial function (RHI)

  6 weeks

• Change in endothelial function (panel of endothelial dysfunction biomarkers)

  6 weeks

• Change in glucose metabolism

  6 weeks

Study Arms (2)

Glucose

ACTIVE COMPARATOR

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

Dietary Supplement: Glucose

Fructose

PLACEBO COMPARATOR

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

Dietary Supplement: Fructose

Interventions

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.

Glucose

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.

Fructose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Body mass index ≥ 28 kg/m2
• Fatty liver index ≥ 60
• Fructose intake ≥45 grams/day

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (3)

• Chen H, Simons PIHG, Simons N, van de Waarenburg MPH, Bons JAP, van der Ploeg EMC, Feskens EJM, Schalkwijk CG, Brouwers MCGJ. Effects of glucose and fructose supplementation on serum sex hormone-binding globulin and testosterone levels: Post-hoc analysis of a double-blind randomized controlled trial. Clin Nutr ESPEN. 2025 Oct;69:384-388. doi: 10.1016/j.clnesp.2025.07.1123. Epub 2025 Jul 26.

  PMID: 40721209 DERIVED

• 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.

  PMID: 36184254 DERIVED

• 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.

  PMID: 33381794 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Glucose Metabolism Disorders

Interventions

Glucose; Fructose

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Martijn CG Brouwers, MD,PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double blind, randomized controlled trial

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 1, 2017
• Study Start: January 31, 2017
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)