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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucose | Active Comparator | Participants will follow a six-week low fructose diet. The amount of restricted fructose will be supplemented as glucose powder. |
|
| Fructose | Placebo Comparator | Participants will follow a six-week low fructose diet. The amount of restricted fructose will be supplemented as fructose powder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intrahepatic triglyceride content | Assessed by magnetic resonance spectroscopy | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in arterial stiffness (PWV) | Assessed by pulse wave velocity | 6 weeks |
| Change in endothelial function (flowmotion and skin heating response) | Assessed by laser doppler flowmetry |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Martijn CG Brouwers, MD,PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6200 MD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40721209 | Derived | 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. | |
| 36184254 |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D005632 | Fructose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 |
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double blind, randomized controlled trial
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|
| 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. |
|
| 6 weeks |
| Change in endothelial function (RHI) | Assessed by reactive hyperemia peripheral arterial tonometry | 6 weeks |
| Change in endothelial function (panel of endothelial dysfunction biomarkers) | Assessed by plasma biomarkers | 6 weeks |
| Change in glucose metabolism | Assessed by a standard 75-gram oral glucose tolerance test | 6 weeks |
| 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. |
| 33381794 | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| Ketoses |