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The effects of FRUctose restrIcTion on LivEr SteatosiS; the FRUITLESS study

The effects of FRUctose restrIcTion on LivEr SteatosiS; the FRUITLESS study - The FRUITLESS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47128
Enrollment
68
Registered
2018-07-18
Start date
2017-03-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease (fatty liver)

Interventions

Low fructose diet, where the amount of fructose restriction will be supplemented by either glucose powder (intervention group) or fructose powder (control group) (with a minimum of 45 gram/day).
Cardiovascular disease
Fructose
Non-alcoholic fatty liver disease

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age *18 years; - BMI * 28; - Fatty liver index * 60.

Exclusion criteria

Exclusion criteria: - Medical history of liver disease, such as viral and auto-immune hepatitis. - (History of) excessive alcohol consumption (defined as > 2 units/day for women, and > 3 units/day for men); - Use of glucose lowering drugs (including insulin); - Recent illness; - Pregnancy and/or lactation; - Major change in weight and/or physical activity prior to the study; - Contraindications for MRI (i.e. claustrophobia, heart pacemaker or other electronic devices implanted in the body, history of collapse or seizure); - Inability to give informed consent.

Design outcomes

Secondary

MeasureTime frame
Markers of cardiovascular risk * i.e. endothelial function, arterial stiffness, plasma lipids, plasma biomarkers of inflammation and endothelial function, and plasma advanced glycation end products * between the intervention and control group.

Primary

MeasureTime frame
Differences in intrahepatic triglyceride content between the intervention and control group.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)