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Burn InjuryExAANCT01618630

Amino Acid Supplementation in Recovery From Severe Burns

A study testing EAA Supplementation + Exercise Training in people with Burn Injury, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 17 years
Conditions the study is for
Burn Injury
What is being tested?
EAA Supplementation + Exercise Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
May 2012to 5 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male or female
  • 7-17 years old
  • Body weight >20 kg (based on blood requirements)
  • ≥30% Total Body Surface Area (TBSA)
  • Wounds 95% healed

Who cannot join

  • Respiratory insufficiency
  • Multiple fractures
  • History of Cancer in the last 5 years
  • Diabetes Mellitus
  • Bilirubin > 3 mg/dl
  • Associated head injuries requiring specific therapy
Show all 15Show fewer
  • Associated injuries to chest or abdomen requiring surgery
  • Serum creatinine > 3 mg/dl after fluid resuscitation
  • Receipt of any experimental drug other than the ones supplied within two months of this study
  • Any metal in body including rods, cardiac defibrillator, pacemakers, etc
  • Orthopedic casting which would prevent placement of patient in MRI machine
  • Hepatitis
  • Abnormal EKG
  • Electrical burns
  • Patients unable to lie still without heavy sedation will be excluded from MRI portion.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Shriners Hospitals for Children

    Galveston, Texas, 77550

Other trials in United States

About this study

Official title: Amino Acid Benefits in Pediatric Burn Patients Who Participate in Exercise.

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.

Read the 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.

Conditions
Burn Injury
Being tested
EAA Supplementation + Exercise Training, Placebo + Exercise Training
Keywords
burn injury, children, nutrition, lipid metabolism, insulin sensitivity, amino acids
Medical subject headings
Burns, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EAA Supplementation + Exercise TrainingDietary supplement

    Amino acids in drinks between meals for exercise training period.

  • Placebo + Exercise TrainingDietary supplement

    Placebo supplementation as drinks in between meals for exercise training period.

Study groups in NCT01618630
Study groupRoleWhat they receive
EAA Supplementation + Exercise TrainingExperimentalDrink an amino acid supplementation during exercise training.
Receives: Dietary Supplement: EAA Supplementation + Exercise Training
Placebo + Exercise TrainingPlacebo comparatorDrink a placebo supplementation during exercise training.
Receives: Dietary Supplement: Placebo + Exercise Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lean Muscle Mass

    Is the total weight of your body minus all the weight due to your fat mass. It is measured in kilograms by dual X-ray absorptiometry scan.

    Measured: It is the change in time, from baseline until post exercise. Baseline is within the first week of discharge from the burn ICU, approximately 1-3 months post burn. Exercise training is 6-12 weeks.

Secondary outcomes (2)
  1. whole body lipolysis rate

    A euglycemic-hyperinsulinemic clamp is performed over the last 2hr of the 4-hr isotope infusion. It is measured in μmol/kg body weight/min

    Measured: It is the change in time, from baseline until post exercise. Baseline is within the first week of discharge from the burn ICU, approximately 1-3 months post burn. Exercise training is 6-12 weeks.

  2. Hepatic glucose release rate and whole body glucose uptake rate

    A primed, constant (0.44 μmol/kg/min) infusion of [6,6-2H2]-glucose is used for glucose kinetics. A euglycemic-hyperinsulinemic clamp is performed over the last 2h of the 4-hr isotope infusion.It is measured in μmol/kg body weight/min.

    Measured: It is the change in time, from baseline until post exercise. Baseline is within the first week of discharge from the burn ICU, approximately 1-3 months post burn. Exercise training is 6-12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2012 (estimated)
  2. Study startMay 2012
  3. Primary completion5 Dec 2016
  4. Study completion5 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01618630
Sponsor's protocol ID
12-048
Acronym
ExAA
Status last verified
Nov 2018
First submitted
30 May 2012
Last updated
11 Dec 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing EAA Supplementation + Exercise Training in people with Burn Injury, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lean Muscle Mass (time frame: It is the change in time, from baseline until post exercise. Baseline is within the first week of discharge from the burn ICU, approximately 1-3 months post burn. Exercise training is 6-12 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.

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