Ketogenic Diet Survey in Patients With McArdle Disease (GSDV)

McArdle Disease Clinical Trial

Official title:

Ketogenic Diet Survey in GSDV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694547
• Other study ID #: Ketogenic diet survey in GSDV
• Status: Completed
• Start date: January 10, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Verified GSDV diagnosis

Exclusion Criteria:

• Age under 18 years

Related Conditions & MeSH terms

• Glycogen Storage Disease Type V
• McArdle Disease

Intervention

Other:
• There is no intervention, as this is a survey study
Survey

Locations

Country	Name	City	State
Denmark	Copenhagen Neuromuscular Center, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Nicoline Løkken

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questions on experiences with a ketogenic diet	Survey	Baseline
Primary	IPAQ (INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE) short form	Survey	Baseline
Primary	MFI-20 (MULTIDIMENSIONAL FATIGUE INVENTORY)	Survey	Baseline
Primary	ISI (insomnia severity index)	Survey	Baseline
Primary	MGQOL 15 score (Myasthenia Gravis Quality Of Life)	Survey	Baseline