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Completed

NCT Number: NCT04694547

Ketogenic Diet Survey in Patients With McArdle Disease (GSDV)

The purpose of this survey is to report experiences with variants of a ketogenic diet in a group of individuals diagnosed with McArdle disease (glycogen storage disease type V). Further more the survey will report on physical activity, fatigue, sleep and quality of life in this cohort.

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Key information

Conditions

McArdle Disease Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Glycogen Storage Disease Glycogen Storage Disease Type V Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen Neuromuscular Center, Rigshospitalet

Copenhagen, Denmark

About this study

Currently, there is no satisfactory treatment for McArdle disease. The limitation in people with McArdle disease is due to a limited availability of energy in the muscle due to affected carbohydrate metabolism. A key element in improving muscle function is therefore to introduce alternative energy sources. Ketone bodies are a well-known source of energy for both brain and muscle. Ketone bodies are produced during fasting or when following a ketogenic diet. A ketogenic diet is a diet high in fat and low in carbohydrates. The classic ketogenic diet contains up to 90% fat, but there are several alternative diets with less fat, including a modified ketogenic diet, Atkins diet, LCHF (low carb high fat), OMAD (one meal a day) and more. This survey will collect information on all variations. The rationale for a ketogenic diet for persons with McArdle disease makes good sense in theory, as the diet would contribute with a new source of energy (ketone bodies) independent of the affected carbohydrate breakdown. However, evidence is sparse on whether the diet actually works. The primary purpose of this survey is to report experiences with variants of the ketogenic diet in a group of individuals diagnosed with McArdle disease. Secondarily this survey will collect information on physical activity, fatigue, sleep and quality of life in this cohort

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Verified GSDV diagnosis

Exclusion criteria

  • Age under 18 years

Treatment and study plan

There is no intervention, as this is a survey study

Other

Survey

Primary outcomes

  1. Questions on experiences with a ketogenic diet

    Time frame: Baseline

    Survey

  2. IPAQ (INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE) short form

    Time frame: Baseline

    Survey

  3. MFI-20 (MULTIDIMENSIONAL FATIGUE INVENTORY)

    Time frame: Baseline

    Survey

  4. ISI (insomnia severity index)

    Time frame: Baseline

    Survey

  5. MGQOL 15 score (Myasthenia Gravis Quality Of Life)

    Time frame: Baseline

    Survey

Sponsors and collaborators

Lead sponsor

Nicoline Løkken

Other

Registry information

Official study title

Ketogenic Diet Survey in GSDV

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2021
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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