Pulmonary Disease, Chronic ObstructiveNCT02770092
CHF COPD Sip Feed Anabolic Response
A study testing sip feeding with stable isotope infusion in people with Pulmonary Disease, Chronic Obstructive and Congestive Heart Failure, run by Texas A&M University at 1 site in United States.
Trial summary
Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic obstructive pulmonary disorder (COPD), negatively influencing their quality of life, treatment response and survival. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Congestive Heart Failure
- What is being tested?
- sip feeding with stable isotope infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2016to 15 May 2018
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to walk, sit down and stand up independently
- Age 45 years or older
- Ability to lie in supine or elevated position for 8 hours
- Diagnosis of CHF; under regular care by cardiologist
- Reduced ejection fraction (<45%) assessed in the past 2 years
- NYHA class II-IV
Show all 22Show fewer
- Clinically stable condition; no hospitalization 4 weeks preceding first study day
- Willingness and ability to comply with the protocol
- Ability to walk, sit down and stand up independently
- Age 45 years or older
- Ability to lie in supine or elevated position for 8 hours
- Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: FEV1 < 70% of reference FEV1
- Clinically stable condition and not suffering from a respiratory tract infection or exacerbation of their disease (defined as a combination of increased cough, sputum purulence, shortness of breath, systemic symptoms such as fever, and a decrease in FEV1 > 10% compared with values when clinically stable in the preceding year) at least 4 weeks prior to the first test day
- Shortness of breath on exertion
- Willingness and ability to comply with the protocol
- Healthy male or female according to the investigator's or appointed staff's judgment
- Ability to walk, sit down and stand up independently
- Age 45 years or older (older control group)
- Age between 20-30 years old (young group)
- Ability to lay in supine or elevated position for 8 hours
- No diagnosis of CHF or COPD
- Willingness and ability to comply with the protocol
Who cannot join
- Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
- Established diagnosis of malignancy
- History of untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Presence of fever within the last 3 days
- Body mass index >40 kg/m2 (healthy subjects only)
Show all 14Show fewer
- Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
- Use of protein or amino acid containing nutritional supplements within 5 days of first study day
- Current Use of long-term oral corticosteroids (CHF only)
- Use of short course of oral corticosteroids within 4 weeks preceding first study day
- Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- (Possible) pregnancy
- Already enrolled in another clinical trial and that clinical trial interferes with participating in this study
- When during the period from enrollment to the test day any condition causing the subject to not meet inclusion criteria or to meet exclusion criteria, the subject will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M University-CTRAL
College Station, Texas, 77843
About this study
Official title: Anabolic Responsiveness to Protein Intake in Chronic Heart Failure and Chronic Obstructive Pulmonary Disorder
Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic obstructive pulmonary disorder (COPD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in CHF and COPD patients, but patients also have reductions in fat mass and bone density, independent of the severity of the disease state. The purpose of this study is to provide detailed insight in disease related gut function by obtaining information on gut permeability, digestion and absorption of glucose, fat and protein in CHF and COPD patients compared to matched healthy controls. This will provide required information that is necessary to implement new strategies to develop optimal nutritional regimen in CHF and COPD.
Read the detailed description
General aims:
- To study the whole-body protein anabolic effect of several dosages of a high-quality protein sip feeding in COPD and CHF subjects as compared to healthy controls.
- To investigate the anabolic threshold in subjects with COPD and CHF as compared to healthy controls.
Purpose and objectives: Although the Researchers' previous study supports the concept of supplementing high-quality milk proteins in chronic wasting diseases i.e., COPD and CHF, the dose-response anabolic effects of proteins with high EAA levels are still unclear. Furthermore, there is no insight in the actual protein requirements in COPD and CHF. The knowledge gained from this study will benefit insight in terms of promotion of protein gain after feeding in COPD and CHF subjects. Based on the obtained data of protein behavior (protein kinetics) the Researchers will be able to further refine and personalize nutritional supplementation in COPD and CHF subjects in order to stop and even restore progressive muscle wasting.
- Being tested
- sip feeding with stable isotope infusion
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sip feeding with stable isotope infusionOther
such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | screening visit: body weight and composition by DXA, height, and vital signs will be assessed.
study day(s): may include combinations of stable isotope infusions and sip feeding with blood draws and cognition testing Receives: Other: sip feeding with stable isotope infusion |
| Chronic Obstructive Pulmonary Disorder | Experimental | screening visit: body weight and composition by DXA, height, and vital signs will be assessed.
study day(s): may include combinations of stable isotope infusions and sip feeding with blood draws and cognition testing Receives: Other: sip feeding with stable isotope infusion |
| Congestive Heart Failure | Experimental | screening visit: body weight and composition by DXA, height, and vital signs will be assessed.
study day(s): may include combinations of stable isotope infusions and sip feeding with blood draws and cognition testing Receives: Other: sip feeding with stable isotope infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in net whole-body protein synthesis
Change in whole-body protein synthesis rate after intake of meal
Measured: 0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 225, 240, 260, 280, 300, 320, 340, 360 ± 5 min
Secondary outcomes (17)
Body Composition
Body composition as measured by Dual-Energy X-ray Absorptiometry
Measured: 15 minutes on screening or study day 1
Skeletal muscle strength
handgrip and kin-com 1-leg test
Measured: on study day 1
Respiratory muscle strength
Maximum inhalation and exhalation pressure
Measured: on study day 1
Gut function
Digestion of the stable tracers of amino acid
Measured: In postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on study day
Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)
a fourteen item self-assessment scale. Seven of the items related to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Executive Function-Adolescent/Adult Sensory Profile (ASP):
a standardized self-questionnaire that generates an individualized profile of sensory processing across four quadrants: low registration, sensation seeking, sensory sensitivity, and sensation avoiding.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in quality of life as measured by Short Form (36) Health Survey (SF36)
self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT).
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE)
questionnaire is intended for use in an elderly population and focuses on 3 types of activities: leisure time activities, household activities and work-related activities.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT),
a word page with words printed in black ink, a color page with blocks printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The total time in seconds was reported for each trial.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in state of mood as measured by the Profile of Mood State (POMS)
A psychological distress scale to measure mood disturbance in 6 domains - fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment. Healthy populations take 3 to 7 minutes to complete, and others may take up a bit longer.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT),
The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total and mean words recorded across the three trials) was reported.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT)
a verbal episodic memory test that evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, retention and recognition of information.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in attention and executive functions as measured by PASAT
a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in attention and executive functions as measured by Trail Making Test (TMT)
n Part A, the examinee is instructed to connect a set of 25 circles with numbers as quickly as possible while maintaining accuracy. In Part B, the examinee is instructed to connect a set of 25 circles, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and mental flexibility. The total time in seconds was reported for each measure.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
assesses several cognitive domains and is used for the screening of mild cognitive impairment. Total scores range from 0-30 with lower scores indicating decreased functioning.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in attention and executive functions as measured by Brief-A
a standardized self-report that captures views of an adult's executive functions or self-regulation in his or her everyday environment.
Measured: Postabsorptive state during 3 hours and change after feeding on study day 1
diet recall
The subject is asked to recall in detail all the food and drink consumed during the 24 hours prior to the test day.
Measured: on study day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start10 Feb 2016
- Primary completion15 May 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Marielle Engelen, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770092
- Sponsor's protocol ID
- IRB2015-0676
- Status last verified
- Sep 2025
- First submitted
- 5 May 2016
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
PubMed 42149813Berger MM, Singer P, Wierzchowska-McNew RA, Viana MV, Ben-David IA, Pantet O, Perez C, Thaden JJ, Engelen MPKJ, Deutz NEP. Cytokine response to critical illness and its relation to amino acid metabolism. Clin Nutr. 2025 Sep;52:195-202. doi: 10.1016/j.clnu.2025.07.018. Epub 2025 Jul 26.
PubMed 40784156Kang MC, Deutz NEP, Kirschner SK, Engelen MPKJ. Metabolic kinetics and muscle and brain health markers in older adults, and the role of age and presence of chronic morbidities: A large cross-sectional cohort study. Clin Nutr. 2024 Dec;43(12):36-47. doi: 10.1016/j.clnu.2024.10.015. Epub 2024 Oct 11.
PubMed 39423760Deutz LN, Wierzchowska-McNew RA, Deutz NE, Engelen MP. Reduced plasma glycine concentration in healthy and chronically diseased older adults: a marker of visceral adiposity? Am J Clin Nutr. 2024 Jun;119(6):1455-1464. doi: 10.1016/j.ajcnut.2024.04.008. Epub 2024 Apr 12.
PubMed 38616018Engelen MPKJ, Kirschner SK, Coyle KS, Argyelan D, Neal G, Dasarathy S, Deutz NEP. Sex related differences in muscle health and metabolism in chronic obstructive pulmonary disease. Clin Nutr. 2023 Sep;42(9):1737-1746. doi: 10.1016/j.clnu.2023.06.031. Epub 2023 Jul 26.
PubMed 37542951Deutz NEP, Singer P, Wierzchowska-McNew RA, Viana MV, Ben-David IA, Pantet O, Thaden JJ, Ten Have GAM, Engelen MPKJ, Berger MM. Females have a different metabolic response to critical illness, measured by comprehensive amino acid flux analysis. Metabolism. 2023 May;142:155400. doi: 10.1016/j.metabol.2023.155400. Epub 2023 Jan 27.
PubMed 36717057Wierzchowska-McNew RA, Engelen MPKJ, Thaden JJ, Ten Have GAM, Deutz NEP. Obesity- and sex-related metabolism of arginine and nitric oxide in adults. Am J Clin Nutr. 2022 Dec 19;116(6):1610-1620. doi: 10.1093/ajcn/nqac277.
PubMed 36166849Pinson MR, Deutz NEP, Harrykissoon R, Zachria AJ, Engelen MPKJ. Disturbances in branched-chain amino acid profile and poor daily functioning in mildly depressed chronic obstructive pulmonary disease patients. BMC Pulm Med. 2021 Nov 7;21(1):351. doi: 10.1186/s12890-021-01719-9.
PubMed 34743729Deutz NEP, Singer P, Wierzchowska-McNew RA, Viana MV, Ben-David IA, Pantet O, Thaden JJ, Ten Have GAM, Engelen MPKJ, Berger MM. Comprehensive metabolic amino acid flux analysis in critically ill patients. Clin Nutr. 2021 May;40(5):2876-2897. doi: 10.1016/j.clnu.2021.03.015. Epub 2021 Mar 18.
PubMed 33946038
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anabolic Responsiveness to Protein Intake in Chronic Heart Failure and Chronic Obstructive Pulmonary Disorder
- ClinicalTrials.gov ID
- NCT02770092
- Acronym / sponsor ID
- IRB2015-0676
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 10 Feb 2016 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 12 May 2016 (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 patients with chronic heart failure (CHF) and chronic obstructive pulmonary disorder (COPD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in CHF and COPD patients, but patients also have reductions in fat mass and bone density, independent of the severity of the disease state. The purpose of this study is to provide detailed insight in disease related gut function by obtaining information on gut permeability, digestion and absorption of glucose, fat and protein in CHF and COPD patients compared to matched healthy controls. This will provide required information that is necessary to implement new strategies to develop optimal nutritional regimen in CHF and COPD.
Detailed description
General aims:
- To study the whole-body protein anabolic effect of several dosages of a high-quality protein sip feeding in COPD and CHF subjects as compared to healthy controls.
- To investigate the anabolic threshold in subjects with COPD and CHF as compared to healthy controls.
Purpose and objectives: Although the Researchers' previous study supports the concept of supplementing high-quality milk proteins in chronic wasting diseases i.e., COPD and CHF, the dose-response anabolic effects of proteins with high EAA levels are still unclear. Furthermore, there is no insight in the actual protein requirements in COPD and CHF. The knowledge gained from this study will benefit insight in terms of promotion of protein gain after feeding in COPD and CHF subjects. Based on the obtained data of protein behavior (protein kinetics) the Researchers will be able to further refine and personalize nutritional supplementation in COPD and CHF subjects in order to stop and even restore progressive muscle wasting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Other: sip feeding with stable isotope infusionscreening visit: body weight and composition by DXA, height, and vital signs will be assessed. study day(s): may include combinations of stable isotope infusions and sip feeding with blood draws and cognition testing |
| Chronic Obstructive Pulmonary Disorder | Experimental | Other: sip feeding with stable isotope infusionscreening visit: body weight and composition by DXA, height, and vital signs will be assessed. study day(s): may include combinations of stable isotope infusions and sip feeding with blood draws and cognition testing |
| Congestive Heart Failure | Experimental | Other: sip feeding with stable isotope infusionscreening visit: body weight and composition by DXA, height, and vital signs will be assessed. study day(s): may include combinations of stable isotope infusions and sip feeding with blood draws and cognition testing |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Ability to walk, sit down and stand up independently
- Age 45 years or older
- Ability to lie in supine or elevated position for 8 hours
- Diagnosis of CHF; under regular care by cardiologist
- Reduced ejection fraction (<45%) assessed in the past 2 years
Key exclusion criteria (14 listed)
- Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
- Established diagnosis of malignancy
- History of untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Presence of fever within the last 3 days
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 |
|---|---|---|
| sip feeding with stable isotope infusionsuch as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline | Other | Chronic Obstructive Pulmonary Disorder, Congestive Heart Failure, Healthy |
Primary outcome
Change in net whole-body protein synthesis
Time frame: 0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 225, 240, 260, 280, 300, 320, 340, 360 ± 5 min
Change in whole-body protein synthesis rate after intake of meal
17 secondary outcomes
Body Composition
Time frame: 15 minutes on screening or study day 1
Skeletal muscle strength
Time frame: on study day 1
Respiratory muscle strength
Time frame: on study day 1
Gut function
Time frame: In postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on study day
Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Executive Function-Adolescent/Adult Sensory Profile (ASP):
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in quality of life as measured by Short Form (36) Health Survey (SF36)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT),
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in state of mood as measured by the Profile of Mood State (POMS)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT),
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in attention and executive functions as measured by PASAT
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in attention and executive functions as measured by Trail Making Test (TMT)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
Group differences in attention and executive functions as measured by Brief-A
Time frame: Postabsorptive state during 3 hours and change after feeding on study day 1
diet recall
Time frame: on study day 1
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 1 Oct 2025.
- Derived from this study: PubMed 42149813Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
- Derived from this study: PubMed 40784156Berger MM, Singer P, Wierzchowska-McNew RA, Viana MV, Ben-David IA, Pantet O, Perez C, Thaden JJ, Engelen MPKJ, Deutz NEP. Cytokine response to critical illness and its relation to amino acid metabolism. Clin Nutr. 2025 Sep;52:195-202. doi: 10.1016/j.clnu.2025.07.018. Epub 2025 Jul 26.
- Derived from this study: PubMed 39423760Kang MC, Deutz NEP, Kirschner SK, Engelen MPKJ. Metabolic kinetics and muscle and brain health markers in older adults, and the role of age and presence of chronic morbidities: A large cross-sectional cohort study. Clin Nutr. 2024 Dec;43(12):36-47. doi: 10.1016/j.clnu.2024.10.015. Epub 2024 Oct 11.
- Derived from this study: PubMed 38616018Deutz LN, Wierzchowska-McNew RA, Deutz NE, Engelen MP. Reduced plasma glycine concentration in healthy and chronically diseased older adults: a marker of visceral adiposity? Am J Clin Nutr. 2024 Jun;119(6):1455-1464. doi: 10.1016/j.ajcnut.2024.04.008. Epub 2024 Apr 12.
- Derived from this study: PubMed 37542951Engelen MPKJ, Kirschner SK, Coyle KS, Argyelan D, Neal G, Dasarathy S, Deutz NEP. Sex related differences in muscle health and metabolism in chronic obstructive pulmonary disease. Clin Nutr. 2023 Sep;42(9):1737-1746. doi: 10.1016/j.clnu.2023.06.031. Epub 2023 Jul 26.
- Derived from this study: PubMed 36717057Deutz NEP, Singer P, Wierzchowska-McNew RA, Viana MV, Ben-David IA, Pantet O, Thaden JJ, Ten Have GAM, Engelen MPKJ, Berger MM. Females have a different metabolic response to critical illness, measured by comprehensive amino acid flux analysis. Metabolism. 2023 May;142:155400. doi: 10.1016/j.metabol.2023.155400. Epub 2023 Jan 27.
- Derived from this study: PubMed 36166849Wierzchowska-McNew RA, Engelen MPKJ, Thaden JJ, Ten Have GAM, Deutz NEP. Obesity- and sex-related metabolism of arginine and nitric oxide in adults. Am J Clin Nutr. 2022 Dec 19;116(6):1610-1620. doi: 10.1093/ajcn/nqac277.
- Derived from this study: PubMed 34743729Pinson MR, Deutz NEP, Harrykissoon R, Zachria AJ, Engelen MPKJ. Disturbances in branched-chain amino acid profile and poor daily functioning in mildly depressed chronic obstructive pulmonary disease patients. BMC Pulm Med. 2021 Nov 7;21(1):351. doi: 10.1186/s12890-021-01719-9.
- Derived from this study: PubMed 33946038Deutz NEP, Singer P, Wierzchowska-McNew RA, Viana MV, Ben-David IA, Pantet O, Thaden JJ, Ten Have GAM, Engelen MPKJ, Berger MM. Comprehensive metabolic amino acid flux analysis in critically ill patients. Clin Nutr. 2021 May;40(5):2876-2897. doi: 10.1016/j.clnu.2021.03.015. Epub 2021 Mar 18.
- Individual participant dataSharing planned: No
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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 Engelen principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sip feeding with stable isotope infusion in people with Pulmonary Disease, Chronic Obstructive and Congestive Heart Failure, 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 22 inclusion and 14 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 1 Oct 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?
Change in net whole-body protein synthesis (time frame: 0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 225, 240, 260, 280, 300, 320, 340, 360 ± 5 min). 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 NCT02770092, which also lists 9 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 1 Oct 2025.