Amino Acid Supplementation in Recovery From Severe Burns

Burn Injury Clinical Trial

— ExAA  

Official title:

Amino Acid Benefits in Pediatric Burn Patients Who Participate in Exercise.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618630
• Other study ID #: 12-048
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: December 5, 2017

Study information

• Verified date: November 2018
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 5, 2017
• Est. primary completion date: December 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Male or female

2. 7-17 years old

3. Body weight >20 kg (based on blood requirements)

4. =30% Total Body Surface Area (TBSA)

5. Wounds 95% healed

Exclusion Criteria:

1. Respiratory insufficiency

2. Multiple fractures

3. History of Cancer in the last 5 years

4. Diabetes Mellitus

5. Bilirubin > 3 mg/dl

6. Associated head injuries requiring specific therapy

7. Associated injuries to chest or abdomen requiring surgery

8. Serum creatinine > 3 mg/dl after fluid resuscitation

9. Receipt of any experimental drug other than the ones supplied within two months of this study

10. Any metal in body including rods, cardiac defibrillator, pacemakers, etc

11. Orthopedic casting which would prevent placement of patient in MRI machine

12. Hepatitis

13. Abnormal EKG

14. Electrical burns

15. Patients unable to lie still without heavy sedation will be excluded from MRI portion.

Related Conditions & MeSH terms

• Burn Injury
• Burns

Intervention

Dietary Supplement:
• EAA Supplementation + Exercise Training
Amino acids in drinks between meals for exercise training period.
• Placebo + Exercise Training
Placebo supplementation as drinks in between meals for exercise training period.

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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	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	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.	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.