Amino Acid Supplementation in Recovery From Severe Burns
Condition: Burn Injury
MeSH terms: Burns
Study type: Interventional

Summary: 
      Exercise during recovery is now Standard of Care at Shriners Hospital for Children Galveston,
      since positive effects of exercise training were found on lean body mass and recovery after
      burns. Essential amino acids (EAA) effective in healthy individuals.Thus, EAA supplementation
      in children recovering from burns, may potentially augment the effects of exercise by
      increase muscle mass, improve muscle fat oxidation, reduce tissue fat, and possibly improve
      insulin resistance.
    

Detailed description: 
      Severe burns result in persistent and extensive fat deposition in liver and muscle tissue.
      This may be related to the prolonged insulin resistance observed following burn. In this
      study the investigators will test the hypothesis that essential amino acids act in synergy
      with exercise to improve liver steatosis and muscle lipid metabolism, and thus also affect
      insulin sensitivity. Children with burns will participate in six weeks of exercise training
      with/without amino acid supplementation. Before and after the intervention, measurements will
      be done to determine muscle and liver fat content, muscle fat and protein metabolism, and
      insulin sensitivity.

      We will prospectively enroll 40 children with ≥30% of their total body surface area (TBSA)
      burned. The age range will be 7-17 years. Children will be recruited from Shriners Hospitals
      for Children (SHC)-Galveston. Burned children will be randomized to undergo an exercise
      program in combination with daily intake of EAA (n=20) or a placebo drink (n=20). The
      exercise program and daily intake of AA will begin within the first week of discharge from
      the burn ICU (approximately 1-3 months post burn, when the patient's wounds are 95% healed).
      The definition of 95% healed is 7 days after the final autografting procedure. We anticipate
      enrolling 10 children per year for 4 years. Only children meeting the inclusion and exclusion
      criteria specified in the Human Subjects Section will be enrolled.

      Nutritional Supplement: The nutritional supplement will be administered at a dose of 0.18
      g/kg body weight of amino acids two times per day with the following composition: 3%
      histidine, 9% isoleucine, 36% leucine, 17% lysine, 4% methionine, 5% phenylalanine, 10%
      threonine, 7% valine, and 10% arginine. The dose and choice of amino acids is based on our
      preliminary data. Each dose is about 0.03 g/kg body weight higher than what has been shown
      effective in adults, as children have higher protein needs. We have shown that only EAA are
      needed to affect muscle protein synthesis and lean mass. Thus the amount given (g or kcal)
      can be restricted. As in our preliminary studies, we will include arginine in the EAA
      mixture, since arginine may have unique anabolic effects (55; 86). Placebo will consist of a
      mixture of inert components (sucralose and other pharmaceutical excipients). The supplement
      will be taken in two daily doses in the form of drinks (total daily dose of i.e., 0.30 g/kg
      body weight total per day), and intake recorded in a diary. The first dose will be taken
      between breakfast and lunch, and the second between lunch and dinner. For the children
      exercising before lunch, the first dose of EAA will be ingested immediately after exercise.
      Correspondingly, for children exercising after lunch, the second EAA dose of the day will be
      ingested immediately after exercise. If the child forgets to take one of the drinks during
      the day, he/she may take the second one between dinner and bedtime. During the weekends,
      parents/caregivers are instructed to take the dosage around the same time.

      Data Analysis and Interpretation. To determine effects of amino acids on fat and muscle lipid
      stores, changes from pre- to post intervention in the two groups will be compared using
      ANCOVA. From the preliminary data, we expect that amino acids will decrease liver and plasma
      lipids.
    

Intervention name(s): EAA Supplementation + Exercise Training; Placebo + Exercise Training
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Amino acids in drinks between meals for exercise training period.; Placebo supplementation as drinks in between meals for exercise training period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: burn injury; children; nutrition; lipid metabolism; insulin sensitivity; amino acids