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

Information source: Texas A&M University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-small Cell Lung Cancer

Intervention: EAA+LEU vs total AA (Dietary Supplement); Total AA vs EAA+LEU (Dietary Supplement)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Texas A&M University

Official(s) and/or principal investigator(s):
Marielle PK Engelen, PhD, Principal Investigator, Affiliation: University of Arkansas


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.

Clinical Details

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

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

Primary outcome: Acute change in Net whole body protein synthesis rate

Secondary outcome:

Acute change in Whole body myofibrillar protein breakdown rate

Acute change in Whole body collagen breakdown rate

Acute change in Urea turnover rate

Acute change in Arginine turnover rate

Acute change in Liver protein synthesis rate

Acute change in plasma Insulin concentrations

Acute change in plasma Amino acid concentrations

Acute change in plasma Glucose concentrations

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.


Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States
Additional Information

Starting date: July 2010
Last updated: November 18, 2014

Page last updated: August 23, 2015

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