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Ketogenic Diet Survey in Patients With McArdle Disease (GSDV)

Ketogenic Diet Survey in GSDV

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04694547
Enrollment
200
Registered
2021-01-05
Start date
2021-01-10
Completion date
2022-12-01
Last updated
2023-02-13

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

Conditions

McArdle Disease

Brief summary

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.

Detailed description

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

Interventions

OTHERThere is no intervention, as this is a survey study

Survey

Sponsors

Nicoline Løkken
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Verified GSDV diagnosis

Exclusion criteria

* Age under 18 years

Design outcomes

Primary

MeasureTime frameDescription
MGQOL 15 score (Myasthenia Gravis Quality Of Life)BaselineSurvey
ISI (insomnia severity index)BaselineSurvey
Questions on experiences with a ketogenic dietBaselineSurvey
IPAQ (INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE) short formBaselineSurvey
MFI-20 (MULTIDIMENSIONAL FATIGUE INVENTORY)BaselineSurvey

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026