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

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ClinicalTrials.gov Identifier: NCT01172314
Recruitment Status : Unknown
Verified April 2019 by Marielle PKJ Engelen, PhD, Texas A&M University.
Recruitment status was:  Active, not recruiting
First Posted : July 29, 2010
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Dietary Supplement: EAA+LEU vs total AA Dietary Supplement: Total AA vs EAA+LEU Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Effects of Essential Amino Acid Intake on Net Protein Synthesis in Weight-losing Non-small Cell Lung Cancer Patients
Study Start Date : July 2010
Actual Primary Completion Date : July 2012
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Acute change in Net whole body protein synthesis rate [ Time Frame: Up to 2 years ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement


Secondary Outcome Measures :
  1. Acute change in Whole body myofibrillar protein breakdown rate [ Time Frame: Up to 2 years ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  2. Acute change in Whole body collagen breakdown rate [ Time Frame: Up to 2 years ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  3. Acute change in Urea turnover rate [ Time Frame: Up to 2 years ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  4. Acute change in Arginine turnover rate [ Time Frame: Up to 2 years ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  5. Acute change in Liver protein synthesis rate [ Time Frame: Up to 2 years ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  6. Acute change in plasma Insulin concentrations [ Time Frame: Up to 2 years ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  7. Acute change in plasma Amino acid concentrations [ Time Frame: Up to 2 years ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement

  8. Acute change in plasma Glucose concentrations [ Time Frame: Up to 2 years ]
    Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172314


Locations
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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
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Principal Investigator: Marielle PK Engelen, PhD University of Arkansas
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Marielle PKJ Engelen, PhD, PhD, Texas A&M University
ClinicalTrials.gov Identifier: NCT01172314    
Other Study ID Numbers: 112254
First Posted: July 29, 2010    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Keywords provided by Marielle PKJ Engelen, PhD, Texas A&M University:
NSCLC
Weight loss
protein metabolism
essential amino acid intake
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms