Health TrialsbyHealthPanel

Essential Amino Acid Supplementation in Adult Spinal Deformity Patients

ConditionAdult Spinal Deformity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorUniversity of Arkansas

About this trial

This will be a randomized double-blind placebo controlled clinical trial to determine if supplementing with essential amino acids (EAAs) for two weeks prior to, and 3 months after corrective spinal surgery in adults with spinal deformity can stimulate greater muscle protein turnover and whole-body protein balance, and enhance recovery after surgery when compared to a calorie matched placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and Females, 40 to 65 years old

Diagnosed with adult spinal deformity

Scheduled for ASD corrective procedure at UAMS (>2 weeks prior to surgery)

Live near Little Rock and scheduled to attend physical therapy in Little Rock

Disqualifiers

Subject who does not/will not eat animal protein sources.

Diagnosed metabolic or hormonal disease (i.e., renal, cardiovascular, thyroid, polycystic ovary syndrome, or type I/II diabetes mellitus).

Currently pregnant.

Gave birth or was lactating within previous 12 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Essential Amino Acid Supplement by Amino Co

    Dietary supplement

    This intervention will be EAA supplementation of 15g twice a day for two weeks before surgery and then 12 weeks post-surgery in individuals diagnosed with ASD

  • Placebo

    Dietary supplement

    Placebo

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Essential Amino Acid Supplement GroupExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Muscle Protein Synthesis

Mixed muscle protein synthesis expressed as the fractional synthetic rate.

Time frame
24 hours

Secondary outcomes

1

Body Composition

Body composition via DEXA will be used to examine lean body mass, fat mass, and bone mineral density. Bioelectrical impedance analysis will be used to determine total body water and muscle quality

Time frame
12 weeks
2

Handgrip Strength & Walking Ability

Hand grip strength in kg and 6-min walk test ability will be examined

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arkansas

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: