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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01172314
• Other study ID #: 112254
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2010
• Est. completion date: February 2021

Study information

• Verified date: April 2019
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: February 2021
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Dietary Supplement:
• EAA+LEU vs total AA
15 g as a bolus
• Total AA vs EAA+LEU
15 g as a bolus

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Up to 2 years
Secondary	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	Up to 2 years
Secondary	Acute change in Urea turnover rate	Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement	Up to 2 years
Secondary	Acute change in Arginine turnover rate	Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement	Up to 2 years
Secondary	Acute change in Liver 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	Acute change in plasma Insulin concentrations	Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement	Up to 2 years
Secondary	Acute change in plasma Amino acid concentrations	Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement	Up to 2 years
Secondary	Acute change in plasma Glucose concentrations	Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement	Up to 2 years