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Modified Ketogenic Diet in Patients With McArdle Disease Part B

NCT04044508 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-02-13

No results posted yet for this study

Summary

McArdle disease, glycogen storage disease type V, is a rare metabolic disease. Affected individuals are unable to utilize sugar stored as glycogen in muscle. Investigators hypothesize that a modified ketogenic diet could be a potential treatment option, by providing ketones as alternative fuel substrates for working muscle.

This blinded, placebo-controlled, cross-over study will investigate the potential effects of an optimal modified ketogenic diet found in part A (75% fat, 15%protein, 10%carbohydrates) in patients with McArdle disease compared with a healthy balanced placebo diet (\>100grams of carbohydrates per day).

Conditions

  • McArdle Disease

Interventions

DIETARY_SUPPLEMENT

Ketocal 4:1 liquid Nutricia (intervention)

Modified ketogenic diet

DIETARY_SUPPLEMENT

Fortini multifibre Nutrica (placebo)

Placebo diet

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-03
Primary Completion
2022-10-01
Completion
2022-12-01

Countries

  • Denmark
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04044508 on ClinicalTrials.gov