Back to resultsEffects of Essential Amino Acid Intake on Net Protein Synthesis in Weight-losing Non-small Cell Lung Cancer Patients
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EAA+LEU vs total AA
Total AA vs EAA+LEU
Sponsored by
About this trial
This is an interventional other trial for Non-small Cell Lung Cancer focused on measuring NSCLC, Weight loss, protein metabolism, essential amino acid intake
Eligibility Criteria
Inclusion Criteria:
- Recently diagnosed with Stage III (unresectable) or Stage IV lung cancer (only for the NSCLC group)
- Ability to sign informed consent
- Age 40 years and older
Exclusion Criteria:
- Previous anti-cancer therapy (e.g. radiotherapy, chemotherapy) or surgery less than 4 weeks prior to the experiment.
- Presence of fever within the last 3 days
- Established diagnosis of Diabetes Mellitus
- BMI > 35 kg/m2
- Untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment
- 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)
- Use of supplements enriched with amino acids
- Any other condition according to the PI or study physicians would interfere with proper conduct of the study / safety of the patient
- Failure to give informed consent
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
EAA+LEU vs total AA
Total AA vs EAA+LEU
Arm Description
Outcomes
Primary Outcome Measures
Acute change in Net whole body protein synthesis rate
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
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
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Acute change in Urea turnover rate
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Acute change in Arginine turnover rate
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Acute change in Liver protein synthesis rate
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Acute change in plasma Insulin concentrations
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Acute change in plasma Amino acid concentrations
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Acute change in plasma Glucose concentrations
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Full Information
NCT ID
NCT01172314
First Posted
July 27, 2010
Last Updated
April 19, 2019
Sponsor
Texas A&M University
Collaborators
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT01172314
Brief Title
Effects of Essential Amino Acid Intake on Net Protein Synthesis in Weight-losing Non-small Cell Lung Cancer Patients
Official Title
Effects of Essential Amino Acid Intake on Net Protein Synthesis in Weight-losing Non-small Cell Lung Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas A&M University
Collaborators
University of Arkansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
NSCLC, Weight loss, protein metabolism, essential amino acid intake
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EAA+LEU vs total AA
Arm Type
Experimental
Arm Title
Total AA vs EAA+LEU
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
EAA+LEU vs total AA
Intervention Description
15 g as a bolus
Intervention Type
Dietary Supplement
Intervention Name(s)
Total AA vs EAA+LEU
Intervention Description
15 g as a bolus
Primary Outcome Measure Information:
Title
Acute change in Net whole body protein synthesis rate
Description
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Acute change in Whole body myofibrillar protein breakdown rate
Description
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Time Frame
Up to 2 years
Title
Acute change in Whole body collagen breakdown rate
Description
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Time Frame
Up to 2 years
Title
Acute change in Urea turnover rate
Description
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Time Frame
Up to 2 years
Title
Acute change in Arginine turnover rate
Description
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Time Frame
Up to 2 years
Title
Acute change in Liver protein synthesis rate
Description
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Time Frame
Up to 2 years
Title
Acute change in plasma Insulin concentrations
Description
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Time Frame
Up to 2 years
Title
Acute change in plasma Amino acid concentrations
Description
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Time Frame
Up to 2 years
Title
Acute change in plasma Glucose concentrations
Description
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Recently diagnosed with Stage III (unresectable) or Stage IV lung cancer (only for the NSCLC group)
Ability to sign informed consent
Age 40 years and older
Exclusion Criteria:
Previous anti-cancer therapy (e.g. radiotherapy, chemotherapy) or surgery less than 4 weeks prior to the experiment.
Presence of fever within the last 3 days
Established diagnosis of Diabetes Mellitus
BMI > 35 kg/m2
Untreated metabolic diseases including hepatic or renal disorder
Presence of acute illness or metabolically unstable chronic illness
Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment
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)
Use of supplements enriched with amino acids
Any other condition according to the PI or study physicians would interfere with proper conduct of the study / safety of the patient
Failure to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marielle PK Engelen, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27146652
Citation
Jonker R, Deutz NE, Erbland ML, Anderson PJ, Engelen MP. Alterations in whole-body arginine metabolism in chronic obstructive pulmonary disease. Am J Clin Nutr. 2016 Jun;103(6):1458-64. doi: 10.3945/ajcn.115.125187. Epub 2016 May 4.
Results Reference
derived
PubMed Identifier
26113648
Citation
Engelen MPKJ, Safar AM, Bartter T, Koeman F, Deutz NEP. High anabolic potential of essential amino acid mixtures in advanced nonsmall cell lung cancer. Ann Oncol. 2015 Sep;26(9):1960-1966. doi: 10.1093/annonc/mdv271. Epub 2015 Jun 25.
Results Reference
derived
Learn more about this trial
Effects of Essential Amino Acid Intake on Net Protein Synthesis in Weight-losing Non-small Cell Lung Cancer Patients
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