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Completed

NCT Number: NCT01172314

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EAA+LEU vs total AA

Dietary Supplement

15 g as a bolus

Total AA vs EAA+LEU

Dietary Supplement

15 g as a bolus

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • University of Arkansas

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 29, 2010
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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