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

NCT01172314 | Completed

• 1 other identifier: 112254
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; Weight loss; protein metabolism; essential amino acid intake

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 2 years

Secondary Outcomes (8)

• Acute change in Whole body myofibrillar protein breakdown rate

  Up to 2 years

• Acute change in Whole body collagen breakdown rate

  Up to 2 years

• Acute change in Urea turnover rate

  Up to 2 years

• Acute change in Arginine turnover rate

  Up to 2 years

• Acute change in Liver protein synthesis rate

  Up to 2 years

Study Arms (2)

EAA+LEU vs total AA

EXPERIMENTAL

Dietary Supplement: EAA+LEU vs total AA

Total AA vs EAA+LEU

EXPERIMENTAL

Dietary Supplement: Total AA vs EAA+LEU

Interventions

EAA+LEU vs total AA DIETARY_SUPPLEMENT

15 g as a bolus

EAA+LEU vs total AA

Total AA vs EAA+LEU DIETARY_SUPPLEMENT

15 g as a bolus

Total AA vs EAA+LEU

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead
• University of Arkansas: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (2)

• 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.

  PMID: 27146652 DERIVED

• 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.

  PMID: 26113648 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Weight Loss

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marielle PK Engelen, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 29, 2010
• Study Start: July 13, 2010
• Primary Completion: February 22, 2012
• Study Completion: February 22, 2012
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

US (1)