None listed
Conditions
Brief summary
This project seeks to explore the efficacy of a standard nutritional supplement in comparison to a standard nutritional supplement enhanced with creatine monohydrate, glutamine and beta-hydroxy-beta-methylbutyrate in maintaining or improving functional ability in boys with Duchenne muscular dystrophy. It combines the expertise of nutrition and dietetics with neurologists to enhance the outcomes of this population group where little is known of their nutritional needs since the standard introduction of steroid therapy. The primary outcome measures functional ability using the StepWatch Activity Monitor. Secondary outcome measures include 6 minute walk test, DXA to measure body composition, functional questionnaires and quality of life questionnaires. Our dietary supplement that we propose to use in this study is contained within a high protein shake, and includes a multivitamin, vitamin D and essential fatty acids given alone or in conjunction with creatine monohydrate (CrM), glutamine, beta-hydroxy-beta-methylbutyrate (HMB). This will be a 12 month, randomized control cross over trial using 24 age matched pairs with a 2 month lead in period and 2 week washout.
Interventions
The enhanced dietary supplement regime will consist of a shake made from 22g whey protein isolate powder administered to provide 20g protein; creatine monohydrate (5g); and glutamine (0.6g/kg fat free mass/day). The enhanced dietary will also include beta-hydroxy-beta-methylbutyrate (38mg/kg/day rounded to nearest 500mg) given in capsule form. Inactive ingredients used in the shake are maltodextrin powder (8g) and sucralose (5g). The shake will be made on 250ml skim milk and will be consumed onc
The enhanced dietary supplement regime will consist of a shake made from 22g whey protein isolate powder administered to provide 20g protein; creatine monohydrate (5g); and glutamine (0.6g/kg fat free mass/day). The enhanced dietary will also include beta-hydroxy-beta-methylbutyrate (38mg/kg/day rounded to nearest 500mg) given in capsule form. Inactive ingredients used in the shake are maltodextrin powder (8g) and sucralose (5g). The shake will be made on 250ml skim milk and will be consumed once per day. The supplement regime also includes a paediatric multivitamin (Vitamin A 582.5 IU, Vitamin B1 350 microg, Vitamin B2 550 microg, Vitamin B3 6 mg, Vitamin B5 1.5 mg, Vitamin B6 650 microg, Vitamin B12 750 microg, Folic acid 50 microg, Vitamin C 20 mg, Vitamin D3 100 IU, Natural Vitamin E 15 IU, Biotin 25 microg, Calcium 5 mg, Iodine 75 microg, Iron 1.3 mg, Magnesium 5 mg, Manganese 12.5 microg, Zinc 1mg; 1 chewable capsules per day for participants aged 5 to 6 years; 2 chewable capsules per day for participants aged 7-12 years), fish oil (1050mg per day in 2 chewable capsules), and vitamin D (2000 IU/day in two gel capsules). This regime will be consumed for 20 weeks. During the two week washout period, participants will be supplied with a standard supplement regime. This consists of a shake made from 22g whey protein isolate powder administered to provide 20g protein. The shake will be made on 250ml skim milk and will be consumed once per day. The standard regime also includes a paediatric multivitamin (Vitamin A 582.5 IU, Vitamin B1 350 microg, Vitamin B2 550 microg, Vitamin B3 6 mg, Vitamin B5 1.5 mg, Vitamin B6 650 microg, Vitamin B12 750 microg, Folic acid 50 microg, Vitamin C 20 mg, Vitamin D3 100 IU, Natural Vitamin E 15 IU, Biotin 25 microg, Calcium 5 mg, Iodine 75 microg, Iron 1.3 mg, Magnesium 5 mg, Manganese 12.5 microg, Zinc 1mg; 1 chewable capsules per day for participants aged 5 to 6 years; 2 chewable capsules per day for participants aged 7-12 years), fish oil (1050mg per day in 2 chewable capsules) , and vitamin D (2000 IU/day in two gel capsules).
Sponsors
The Royal Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
5 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
Boys will be considered for inclusion if they have a definite diagnosis: phenotypic evidence of Duchenne muscular dystrophy (DMD) based on the onset of characteristic clinical symptoms or signs (ie, proximal muscle weakness, waddling gait, and Gowers’ maneuver) by 9 years of age, an elevated serum creatine kinase (CK), and ongoing difficulty with ambulation, with documentation of a deletion or duplication in the dystrophin gene, or absence of Dystrophin on muscle biopsy. Boys also need to be sufficiently ambulatory to walk = 75 meters unassisted during a 6 minute walk test (6MWT). Other personal assistance or use of assistive devices for ambulation (eg, short leg braces, long leg braces, or walkers) is not permitted. Parents/guardians need to be able to give full informed written consent.
Exclusion criteria
use of a wheelchair/motorised scooter/similar mobility aid for >75 % of activity during the day; cows milk protein allergy or lactose intolerance; history of kidney or liver disease; unable to attend the seven required hospital appointments within the 12 month period; unable to swallow tablets; parents wish to continue using other complementary therapies; participation in other muscular dystrophy trials involving an active intervention; use of medications which are contraindicated due to possible drug interactions.
Outcome results
None listed