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