COPDNCT01734473
Casein Protein and Leucine Supplementation in Chronic Obstructive Pulmonary Disease (COPD)
A study testing Hydrolyzed casein protein, Hydrolyzed casein protein + carbohydrates and Hydrolyzed casein protein + leucine in people with COPD, run by Texas A&M University at 1 site in United States.
Trial summary
Weight loss commonly occurs in patients with COPD, negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of this weight loss and independently increases mortality. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Hydrolyzed casein protein, Hydrolyzed casein protein + carbohydrates and Hydrolyzed casein protein + leucine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2012to 27 May 2015
- 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 5.5 hours
- Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: Forced Expiratory Volume(FEV1)/Forced Vital Capacity (FVC) < 0.70 and 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
Show all 15Show fewer
- Willingness and ability to comply with the protocol, including:
- Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study visit
- 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
- Ability to lay in supine or elevated position for 5.5 hours
- No diagnosis of chronic airflow limitation and compliant to the following criteria: FEV1/FVC > 0.70 and FEV1 ≥ 80% of reference FEV1
- Willingness and ability to comply with the protocol, including:
- Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study visit
Who cannot join
- Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only)
- Established diagnosis of malignancy
- Established diagnosis of Insulin Dependent Diabetes Mellitus
- History of untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Recent myocardial infarction (less than 1 year)
Show all 16Show 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
- BMI of < 18.5 or ≥ 35 kg/m2
- Dietary or lifestyle characteristics:
- Use of protein or amino acid containing nutritional supplements within 5 days of first test day
- Current alcohol or drug abuse
- Indications related to interaction with study products:
- Known allergy to milk or milk products
- Use of long-term oral corticosteroids or short course of oral corticosteroids 4 weeks preceding first test 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Casein Protein and Leucine Supplementation to Induce Anabolism in COPD Patients and Healthy Elderly
Weight loss commonly occurs in patients with COPD, negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of this weight loss and independently increases mortality. This study will provide relevant clinical information in regards to the anabolic properties of specific dietary substrates and their co-active anabolic effects. Hypotheses: 1) That supplementation of a hydrolyzed casein-based protein meal with the addition of carbohydrates is more anabolic than a hydrolyzed casein-based protein meal without carbohydrates in COPD patients and healthy older adults; 2) That leucine addition to a hydrolyzed casein-based protein meal only enhances the protein anabolic response in COPD patients and healthy older adults when carbohydrates are not added to the protein meal; 3) That COPD patients have a more efficient protein anabolic response to a hydrolyzed casein-based protein meal than healthy older adults.
A fifth study day was added to measure protein requirements of included individuals to be able to interpret their response to the other interventions on the other study days, and to test the hypothesis that subjects with lower protein requirements respond less to intervention with leucine and/or carbohydrates. For the 5th additional test day we will first approach the 10 COPD and 10 healthy subjects who already completed the first 4 study days (and signed the re-contact form) to come back for this extra test day. We will (pre-)screen these subjects by phone for eligibility and check for changes in their recent medical history (with help of the (pre-)screening questionnaires in CRF). If all inclusion criteria are still met, these subjects will be asked to provide a written re-consent. If necessary, we will recruit new subjects who will complete only one of the four test days (i.e. the test day on which the hydrolyzed casein-based protein meal with carbohydrates is provided) and the additional 5th study day.
Read the detailed description
The study involves 5 study days. The duration of the first 4 study days is approximately 6.5 hours per day and the duration of the 5th study day is approximately 8 hours. On each of the first 4 study days the effect a casein protein meal with or without leucine and carbohydrates will be examined. On the fifth study day the effect of 4 different levels of casein protein and carbohydrate intake by sip feeding (every 20 minutes) is examined.
Also, subjects will receive a mixture of amino acids (little parts of protein) which are a little bit heavier than normal, called stable isotopes. This is the so-called stable isotope method to investigate protein behavior in the body (protein kinetics). Altogether about 75 ml of blood will be drawn per study day to assess outcome measures.
- Conditions
- COPD
- Being tested
- Hydrolyzed casein protein, Hydrolyzed casein protein + carbohydrates, Hydrolyzed casein protein + leucine, Hydrolyzed casein protein + carbohydrates + leucine, 4 levels of hydrolyzed casein protein + carbohydrates
- Keywords
- COPD, Protein synthesis, Protein breakdown, Muscle wasting, Leucine, Hydrolyzed, Casein protein, Carbohydrates
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolyzed casein proteinDietary supplement
Also called PeptoPro
Amount provided is based on the fat-free mass of subject
Hydrolyzed casein protein + carbohydratesDietary supplement
Also called PeptoPro + maltodextrin
Amount provided is based on the fat-free mass of subject
Hydrolyzed casein protein + leucineDietary supplement
Also called PeptoPro + leucine
Amount provided is based on the fat-free mass of subject. Leucine (40% of essential amino acid content)
Hydrolyzed casein protein + carbohydrates + leucineDietary supplement
Also called PeptoPro + maltodextrin + leucine
Amount provided is based on the fat-free mass of subject. Leucine (40% of essential amino acid content)
4 levels of hydrolyzed casein protein + carbohydratesDietary supplement
Also called 4 levels of PeptoPro + maltodextrin
Amount provided is based on the fat-free mass of subject. The 4 levels are: 0, 0.02, 0.05, 0.15 g casein protein/kg fat free mass/hr. The ratio between protein and carbohydrates is fixed.
| Study group | Role | What they receive |
|---|---|---|
| Study day 1 | Experimental | Hydrolyzed casein protein. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order. Receives: Dietary Supplement: Hydrolyzed casein protein |
| Study day 2 | Experimental | Hydrolyzed casein protein + carbohydrates. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order. Receives: Dietary Supplement: Hydrolyzed casein protein + carbohydrates |
| Study day 3 | Experimental | Hydrolyzed casein protein + leucine. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order. Receives: Dietary Supplement: Hydrolyzed casein protein + leucine |
| Study day 4 | Experimental | Hydrolyzed casein protein + carbohydrates + leucine. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order. Receives: Dietary Supplement: Hydrolyzed casein protein + carbohydrates + leucine |
| Study Day 5 | Experimental | 4 levels of hydrolyzed casein protein + carbohydrates Receives: Dietary Supplement: 4 levels of hydrolyzed casein protein + carbohydrates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net whole-body protein synthesis
Change in net whole-body protein synthesis (whole-body protein synthesis - whole-body protein breakdown)
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Net whole-body protein synthesis with different levels of protein intake (Fifth Study Day)
Change in net whole-body protein synthesis (whole-body protein synthesis - whole-body protein breakdown) with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Measured: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Secondary outcomes (15)
Whole-body protein synthesis
Change in whole-body protein synthesis
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Whole-body protein breakdown
Change in whole-body protein breakdown
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Splanchnic extraction
The amount of amino acids in the protein meal extracted by the splanchnic tissues after intake
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Body composition
Difference in muscle mass, fat mass and bone density between COPD patients and healthy older adults
Measured: 1 day
Skeletal and respiratory muscle strength
Difference in handgrip strength and fatigue and maximum inspiratory and expiratory pressure between COPD patients and healthy older adults
Measured: 1 day
Inflammatory mediators
C-reactive protein, interleukines
Measured: 90 min before protein meal
Hormones
Area under the plasma concentration versus time curve (AUC) of insulin
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Glucose
Peak plasma concentration (Cmax) of glucose
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Amino acid concentrations
Peak plasma concentration (Cmax) of amino acids
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Whole-body protein synthesis with different levels of protein intake (Fifth Study Day)
Change in whole-body protein synthesis with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Measured: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Whole-body protein breakdown with different levels of protein intake (Fifth Study Day)
Change in whole-body protein breakdown with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Measured: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Splanchnic extraction with different levels of protein intake (Fifth Study Day)
The amount of amino acids in the protein meal extracted by the splanchnic tissues after intake of 4 different levels of protein (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Measured: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Hormones with different levels of protein intake (Fifth Study Day)
Area under the plasma concentration versus time curve (AUC) of insulin with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Measured: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Glucose with different levels of protein intake (Fifth Study Day)
Peak plasma concentration (Cmax) of glucose with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Measured: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Amino acid concentrations with different levels of protein intake (Fifth Study Day)
Peak plasma concentration (Cmax) of amino acids with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Measured: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study start28 Nov 2012
- Primary completion27 May 2015
- Study completion27 May 2015
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 COPDStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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 PK Engelen, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734473
- Sponsor's protocol ID
- 2012-0561
- Status last verified
- Sep 2025
- First submitted
- 21 Nov 2012
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Jonker R, Deutz NEP, Schols AMWJ, Veley EA, Harrykissoon R, Zachria AJ, Engelen MPKJ. Whole body protein anabolism in COPD patients and healthy older adults is not enhanced by adding either carbohydrates or leucine to a serving of protein. Clin Nutr. 2019 Aug;38(4):1684-1691. doi: 10.1016/j.clnu.2018.08.006. Epub 2018 Aug 16.
PubMed 30150004Jonker R, Deutz NEP, Ligthart-Melis GC, Zachria AJ, Veley EA, Harrykissoon R, Engelen MPKJ. Preserved anabolic threshold and capacity as estimated by a novel stable tracer approach suggests no anabolic resistance or increased requirements in weight stable COPD patients. Clin Nutr. 2019 Aug;38(4):1833-1843. doi: 10.1016/j.clnu.2018.07.018. Epub 2018 Jul 31.
PubMed 30100106
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
- Casein Protein and Leucine Supplementation to Induce Anabolism in COPD Patients and Healthy Elderly
- ClinicalTrials.gov ID
- NCT01734473
- Acronym / sponsor ID
- 2012-0561
- Conditions
- COPD
- Keywords
- COPD, Protein synthesis, Protein breakdown, Muscle wasting, Leucine, Hydrolyzed, Casein protein, Carbohydrates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 28 Nov 2012 (actual)
- Primary completion
- 27 May 2015 (actual)
- Study completion
- 27 May 2015 (actual)
- First posted
- 27 Nov 2012 (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 COPD, negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of this weight loss and independently increases mortality. This study will provide relevant clinical information in regards to the anabolic properties of specific dietary substrates and their co-active anabolic effects. Hypotheses: 1) That supplementation of a hydrolyzed casein-based protein meal with the addition of carbohydrates is more anabolic than a hydrolyzed casein-based protein meal without carbohydrates in COPD patients and healthy older adults; 2) That leucine addition to a hydrolyzed casein-based protein meal only enhances the protein anabolic response in COPD patients and healthy older adults when carbohydrates are not added to the protein meal; 3) That COPD patients have a more efficient protein anabolic response to a hydrolyzed casein-based protein meal than healthy older adults.
A fifth study day was added to measure protein requirements of included individuals to be able to interpret their response to the other interventions on the other study days, and to test the hypothesis that subjects with lower protein requirements respond less to intervention with leucine and/or carbohydrates. For the 5th additional test day we will first approach the 10 COPD and 10 healthy subjects who already completed the first 4 study days (and signed the re-contact form) to come back for this extra test day. We will (pre-)screen these subjects by phone for eligibility and check for changes in their recent medical history (with help of the (pre-)screening questionnaires in CRF). If all inclusion criteria are still met, these subjects will be asked to provide a written re-consent. If necessary, we will recruit new subjects who will complete only one of the four test days (i.e. the test day on which the hydrolyzed casein-based protein meal with carbohydrates is provided) and the additional 5th study day.
Detailed description
The study involves 5 study days. The duration of the first 4 study days is approximately 6.5 hours per day and the duration of the 5th study day is approximately 8 hours. On each of the first 4 study days the effect a casein protein meal with or without leucine and carbohydrates will be examined. On the fifth study day the effect of 4 different levels of casein protein and carbohydrate intake by sip feeding (every 20 minutes) is examined.
Also, subjects will receive a mixture of amino acids (little parts of protein) which are a little bit heavier than normal, called stable isotopes. This is the so-called stable isotope method to investigate protein behavior in the body (protein kinetics). Altogether about 75 ml of blood will be drawn per study day to assess outcome measures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Study day 1 | Experimental | Dietary Supplement: Hydrolyzed casein proteinHydrolyzed casein protein. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order. |
| Study day 2 | Experimental | Dietary Supplement: Hydrolyzed casein protein + carbohydratesHydrolyzed casein protein + carbohydrates. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order. |
| Study day 3 | Experimental | Dietary Supplement: Hydrolyzed casein protein + leucineHydrolyzed casein protein + leucine. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order. |
| Study day 4 | Experimental | Dietary Supplement: Hydrolyzed casein protein + carbohydrates + leucineHydrolyzed casein protein + carbohydrates + leucine. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order. |
| Study Day 5 | Experimental | Dietary Supplement: 4 levels of hydrolyzed casein protein + carbohydrates4 levels of hydrolyzed casein protein + carbohydrates |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Ability to walk, sit down and stand up independently
- Age 45 years or older
- Ability to lie in supine or elevated position for 5.5 hours
- Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: Forced Expiratory Volume(FEV1)/Forced Vital Capacity (FVC) < 0.70 and 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
Key exclusion criteria (16 listed)
- Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only)
- Established diagnosis of malignancy
- Established diagnosis of Insulin Dependent Diabetes Mellitus
- History of untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
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 |
|---|---|---|
| Hydrolyzed casein proteinAlso: PeptoProAmount provided is based on the fat-free mass of subject | Dietary supplement | Study day 1 |
| Hydrolyzed casein protein + carbohydratesAlso: PeptoPro + maltodextrinAmount provided is based on the fat-free mass of subject | Dietary supplement | Study day 2 |
| Hydrolyzed casein protein + leucineAlso: PeptoPro + leucineAmount provided is based on the fat-free mass of subject. Leucine (40% of essential amino acid content) | Dietary supplement | Study day 3 |
| Hydrolyzed casein protein + carbohydrates + leucineAlso: PeptoPro + maltodextrin + leucineAmount provided is based on the fat-free mass of subject. Leucine (40% of essential amino acid content) | Dietary supplement | Study day 4 |
| 4 levels of hydrolyzed casein protein + carbohydratesAlso: 4 levels of PeptoPro + maltodextrinAmount provided is based on the fat-free mass of subject. The 4 levels are: 0, 0.02, 0.05, 0.15 g casein protein/kg fat free mass/hr. The ratio between protein and carbohydrates is fixed. | Dietary supplement | Study Day 5 |
Primary outcome
Net whole-body protein synthesis
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Change in net whole-body protein synthesis (whole-body protein synthesis - whole-body protein breakdown)
Net whole-body protein synthesis with different levels of protein intake (Fifth Study Day)
Time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Change in net whole-body protein synthesis (whole-body protein synthesis - whole-body protein breakdown) with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
15 secondary outcomes
Whole-body protein synthesis
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Whole-body protein breakdown
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Splanchnic extraction
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Body composition
Time frame: 1 day
Skeletal and respiratory muscle strength
Time frame: 1 day
Inflammatory mediators
Time frame: 90 min before protein meal
Hormones
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Glucose
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Amino acid concentrations
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Whole-body protein synthesis with different levels of protein intake (Fifth Study Day)
Time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Whole-body protein breakdown with different levels of protein intake (Fifth Study Day)
Time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Splanchnic extraction with different levels of protein intake (Fifth Study Day)
Time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Hormones with different levels of protein intake (Fifth Study Day)
Time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Glucose with different levels of protein intake (Fifth Study Day)
Time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Amino acid concentrations with different levels of protein intake (Fifth Study Day)
Time frame: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
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 30150004Jonker R, Deutz NEP, Schols AMWJ, Veley EA, Harrykissoon R, Zachria AJ, Engelen MPKJ. Whole body protein anabolism in COPD patients and healthy older adults is not enhanced by adding either carbohydrates or leucine to a serving of protein. Clin Nutr. 2019 Aug;38(4):1684-1691. doi: 10.1016/j.clnu.2018.08.006. Epub 2018 Aug 16.
- Derived from this study: PubMed 30100106Jonker R, Deutz NEP, Ligthart-Melis GC, Zachria AJ, Veley EA, Harrykissoon R, Engelen MPKJ. Preserved anabolic threshold and capacity as estimated by a novel stable tracer approach suggests no anabolic resistance or increased requirements in weight stable COPD patients. Clin Nutr. 2019 Aug;38(4):1833-1843. doi: 10.1016/j.clnu.2018.07.018. Epub 2018 Jul 31.
- PeptoProLink provided by the sponsor.
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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
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolyzed casein protein, Hydrolyzed casein protein + carbohydrates and Hydrolyzed casein protein + leucine in people with COPD, 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 15 inclusion and 16 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?
Net whole-body protein synthesis (time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal). The study lists 2 primary outcomes in all. 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 NCT01734473, 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.