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Effects of Essential Amino Acid Intake on Net Protein Synthesis in Weight-losing Non-small Cell Lung Cancer Patients


N/A
40 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

Effects of Essential Amino Acid Intake on Net Protein Synthesis in Weight-losing Non-small Cell Lung Cancer Patients


In this study, we will test the following hypothesis: A high-leucine essential amino acid
mixture stimulates whole body protein synthesis (and in this way protein anabolism) to a
larger extent than a regular balanced mixture of total (essential and non-essential) amino
acids in NSCLC patients with and without recent weight loss. The principal endpoint will be
the extent of stimulation of protein synthesis rate as this is the principal mechanism by
which either amino acid or protein intake causes muscle anabolism. This project will provide
important clinical information, based on novel fundamental basic knowledge on the process
and the specific underlying mechanisms of muscle wasting in patients with NSCLC, and the
role of EAA as a potential anabolic substrate. In this way, it will provide preliminary data
for the development of nutritional strategies that will prevent or even stop this process of
ongoing muscle loss in NSCLC.


Inclusion Criteria:



1. Recently diagnosed with Stage III (unresectable) or Stage IV lung cancer (only for
the NSCLC group)

2. Ability to sign informed consent

3. Age 40 years and older

Exclusion Criteria:

1. Previous anti-cancer therapy (e.g. radiotherapy, chemotherapy) or surgery less than 4
weeks prior to the experiment.

2. Presence of fever within the last 3 days

3. Established diagnosis of Diabetes Mellitus

4. BMI > 35 kg/m2

5. Untreated metabolic diseases including hepatic or renal disorder

6. Presence of acute illness or metabolically unstable chronic illness

7. Use of long-term oral corticosteroids or short course of oral corticosteroids in the
preceding month before enrollment

8. Diagnosis of moderate to severe chronic airflow limitation, defined as measured
forced expiratory volume in one second (FEV1) ≤ 70% of referen¬ce FEV1 (only for the
healthy control group)

9. Use of supplements enriched with amino acids

10. Any other condition according to the PI or study physicians would interfere with
proper conduct of the study / safety of the patient

11. Failure to give informed consent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Outcome Measure:

Acute change in Net whole body protein synthesis rate

Outcome Description:

Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Marielle PK Engelen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Institutional Review Board

Study ID:

112254

NCT ID:

NCT01172314

Start Date:

July 2010

Completion Date:

December 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Weight loss
  • protein metabolism
  • essential amino acid intake
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205