RecruitingNot ApplicableNCT06852612

Dietary Treatment Strategies and Metabolic Control in Glycogen Storage Disease Type I

Dietary Treatment Strategies and Metabolic Control in Glycogen Storage Disease Type I (GSD-DIET)


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

20 participants

Start Date

Apr 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The present project will specifically assess metabolic effects of dietary interventions with controlled intake of fructose and fructose/galactose in GSDI, with the aim to provide evidence whether relaxed dietary restrictions of fructose and galactose may be justified in treatment recommendations at least for adults, which would considerably enlarge food choice in everyday life of the patients with an expected positive impact on the quality of life of patients with this rare disorder.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Genetically and/or enzymatically confirmed diagnosis of GSDI (GSDIa or GSDIb)
  • Male or female ≥ 18y
  • Restriction of fructose intake in usual dietary treatment
  • Written informed consent

Exclusion Criteria6

  • Non-compliance with routine dietary treatment
  • Pregnancy or lactation
  • Liver transplant
  • Recurrent hospitalisations due to metabolic decompensation within the last 12 months
  • Severe chronic kidney disease with glomerular filtration rate (GFR) < 30 ml/min
  • For GSDIb: Severe, uncontrolled symptomatic inflammatory bowel disease

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Interventions

DIETARY_SUPPLEMENTFructose

40g fructose (free and bound, max amount of fructose from added free sugar/saccharose 25g)

DIETARY_SUPPLEMENTFructose and galactose

10g galactose (mostly from lactose) plus 40g of fructose (free and bound, max amount of fructose from added free sugar/saccharose 25g)


Locations(1)

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital

Bern, Switzerland

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NCT06852612