- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04694547
Ketogenic Diet Survey in Patients With McArdle Disease (GSDV)
February 10, 2023 updated by: Nicoline Løkken
Ketogenic Diet Survey in 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicoline Løkken
- Phone Number: +4535458748
- Email: nicoline.loekken@regionh.dk
Study Locations
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-
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Copenhagen, Denmark
- Copenhagen Neuromuscular Center, Rigshospitalet
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
McArdle disease
Description
Inclusion Criteria:
- Verified GSDV diagnosis
Exclusion Criteria:
- Age under 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questions on experiences with a ketogenic diet
Time Frame: Baseline
|
Survey
|
Baseline
|
IPAQ (INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE) short form
Time Frame: Baseline
|
Survey
|
Baseline
|
MFI-20 (MULTIDIMENSIONAL FATIGUE INVENTORY)
Time Frame: Baseline
|
Survey
|
Baseline
|
ISI (insomnia severity index)
Time Frame: Baseline
|
Survey
|
Baseline
|
MGQOL 15 score (Myasthenia Gravis Quality Of Life)
Time Frame: Baseline
|
Survey
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 10, 2021
Primary Completion (ACTUAL)
November 1, 2022
Study Completion (ACTUAL)
December 1, 2022
Study Registration Dates
First Submitted
October 5, 2020
First Submitted That Met QC Criteria
January 4, 2021
First Posted (ACTUAL)
January 5, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 13, 2023
Last Update Submitted That Met QC Criteria
February 10, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ketogenic diet survey in GSDV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University College, LondonCompleted
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IRCCS Eugenio MedeaUniversity of Pisa; University of MessinaCompleted
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