Non-small Cell Lung CancerNCT01172314
Effects of Essential Amino Acid Intake on Net Protein Synthesis in Weight-losing Non-small Cell Lung Cancer Patients
A study testing EAA+LEU vs total AA and Total AA vs EAA+LEU in people with Non-small Cell Lung Cancer, run by Texas A&M University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- EAA+LEU vs total AA and Total AA vs EAA+LEU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2010to 22 Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- EAA+LEU vs total AA, Total AA vs EAA+LEU
- Keywords
- NSCLC, Weight loss, protein metabolism, essential amino acid intake
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAA+LEU vs total AADietary supplement
15 g as a bolus
Total AA vs EAA+LEUDietary supplement
15 g as a bolus
| Study group | Role | What they receive |
|---|---|---|
| EAA+LEU vs total AA | Experimental | Not described Receives: Dietary Supplement: EAA+LEU vs total AA |
| Total AA vs EAA+LEU | Experimental | Not described Receives: Dietary Supplement: Total AA vs EAA+LEU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 years
Secondary outcomes (8)
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
Measured: Up to 2 years
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
Measured: Up to 2 years
Acute change in Urea turnover rate
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 2 years
Acute change in Arginine turnover rate
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 2 years
Acute change in Liver protein synthesis rate
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 2 years
Acute change in plasma Insulin concentrations
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 2 years
Acute change in plasma Amino acid concentrations
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 2 years
Acute change in plasma Glucose concentrations
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study start13 Jul 2010
- Primary completion22 Feb 2012
- Study completion22 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Marielle PK Engelen, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172314
- Sponsor's protocol ID
- 112254
- Status last verified
- Sep 2025
- First submitted
- 27 Jul 2010
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27146652Engelen 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.
PubMed 26113648
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Essential Amino Acid Intake on Net Protein Synthesis in Weight-losing Non-small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT01172314
- Acronym / sponsor ID
- 112254
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, Weight loss, protein metabolism, essential amino acid intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- University of Arkansas
- Study start
- 13 Jul 2010 (actual)
- Primary completion
- 22 Feb 2012 (actual)
- Study completion
- 22 Feb 2012 (actual)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EAA+LEU vs total AA15 g as a bolus | Dietary supplement | EAA+LEU vs total AA |
| Total AA vs EAA+LEU15 g as a bolus | Dietary supplement | Total AA vs EAA+LEU |
Primary outcome
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
8 secondary outcomes
Acute change in Whole body myofibrillar protein breakdown rate
Time frame: Up to 2 years
Acute change in Whole body collagen breakdown rate
Time frame: Up to 2 years
Acute change in Urea turnover rate
Time frame: Up to 2 years
Acute change in Arginine turnover rate
Time frame: Up to 2 years
Acute change in Liver protein synthesis rate
Time frame: Up to 2 years
Acute change in plasma Insulin concentrations
Time frame: Up to 2 years
Acute change in plasma Amino acid concentrations
Time frame: Up to 2 years
Acute change in plasma Glucose concentrations
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 27146652Jonker 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.
- Derived from this study: PubMed 26113648Engelen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marielle PK Engelen, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EAA+LEU vs total AA and Total AA vs EAA+LEU in people with Non-small Cell Lung Cancer, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute change in Net whole body protein synthesis rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01172314, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.