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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University
ClinicalTrials.gov Identifier:
NCT01172314
First received: July 27, 2010
Last updated: June 12, 2013
Last verified: June 2013
History of Changes
  Purpose

Weight loss commonly occurs in lung cancer patients, negatively influencing their quality of life, treatment response and survival. Gains in lean body mass are difficult to achieve in cancer unless specific metabolic abnormalities are targeted. It is our hypothesis that a nutritional supplement containing a high amount of essential amino acids will target the metabolic alterations of cancer patients. Preliminary research performed in our laboratory in elderly supports this hypothesis. We hypothesize that intake of an essential amino acid nutritional supplement will positively influence protein synthesis rate in advanced non-small cell lung cancer (NSCLC) patients. Furthermore, insight in the underlying mechanism of the higher anabolic response of the essential amino acid supplement will be examined. This information will potentially enable us to formulate a supplement that is more effective than normal food intake, and that will reduce the need for muscle protein breakdown.


Condition Intervention
Non-small Cell Lung Cancer
 Dietary Supplement: EAA+LEU vs total AA
Dietary Supplement: Total AA vs EAA+LEU

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effects of Essential Amino Acid Intake on Net Protein Synthesis in Weight-losing Non-small Cell Lung Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Texas A&M University:

Primary Outcome Measures:
  • Acute change in Net whole body protein synthesis rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement


Secondary Outcome Measures:
  • Acute change in Whole body myofibrillar protein breakdown rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  • Acute change in Whole body collagen breakdown rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  • Acute change in Urea turnover rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  • Acute change in Arginine turnover rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  • Acute change in Liver protein synthesis rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  • Acute change in plasma Insulin concentrations [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  • Acute change in plasma Amino acid concentrations [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  • Acute change in plasma Glucose concentrations [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement


Estimated Enrollment: 47
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EAA+LEU vs total AA Dietary Supplement: EAA+LEU vs total AA
15 g as a bolus
Experimental: Total AA vs EAA+LEU Dietary Supplement: Total AA vs EAA+LEU
15 g as a bolus

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172314

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
Texas A&M University
University of Arkansas
Investigators
Principal Investigator: Marielle PK Engelen, PhD University of Arkansas
  More Information

No publications provided

Responsible Party: Marielle PKJ Engelen, PhD, PhD, Texas A&M University
ClinicalTrials.gov Identifier: NCT01172314     History of Changes
Other Study ID Numbers: 112254
Study First Received: July 27, 2010
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Texas A&M University:
NSCLC
Weight loss
protein metabolism
essential amino acid intake

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 13, 2013