Chronic Obstructive Pulmonary DiseaseNCT01154400
Hydrolyzed Casein and Whey Protein Supplementation and the Addition of Leucine to Induce Protein Anabolism in Malnourished COPD Patients
A study testing Casein protein hydrolysates, Whey protein hydrolysates and Casein protein hydrolysates + LEU in people with Chronic Obstructive Pulmonary Disease, run by Texas A&M University at 1 site in United States.
Trial summary
The aim of this study is the first aim of a NIH project that consists of 3 aims. The first aim examines the acute effects of two high-quality milk proteins (casein vs. whey) on whole-body and muscle protein metabolism in COPD patients with severe loss of muscle mass and the effects of adding leucine. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Casein protein hydrolysates, Whey protein hydrolysates and Casein protein hydrolysates + LEU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jul 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of moderate to severe chronic airflow limitation, defined as measured forced expiratory volume in one second (FEV1) ≤ 70% of reference FEV1
- Shortness of breath on exertion
- Age 45 years and older
- Clinically stable condition and not suffering from 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) at least 4 weeks prior to the study
- Cachexia based on the criteria: Body mass index ≤ 25 kg/m2 and/or FFM-Index: FFM/height2 ≤ 17 (males), 15 (females) kg/m2 and/or recent involuntary weight loss
Who cannot join
- Established diagnosis of malignancy
- Presence of fever within the last 3 days
- Established diagnosis of Diabetes Mellitus
- 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 10Show fewer
- Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment
- Allergy to cow's milk protein
- 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
Official title: Grant Title: Eicosapentaenoic Acid and Protein Modulation to Induce Anabolism in COPD
The aim of this study is the first aim of a NIH project that consists of 3 aims. The first aim examines the acute effects of two high-quality milk proteins (casein vs. whey) on whole-body and muscle protein metabolism in COPD patients with severe loss of muscle mass and the effects of adding leucine. The principal endpoints will be the extent of stimulation of net whole body protein synthesis as this is the principal mechanism by which either amino acid or protein intake causes muscle anabolism. After determining the optimal nutritional formulation based on the first aim we will continue to work on the second and third aim where fish oil supplementation will be part of the nutritional intervention as well.
Read the detailed description
Cachectic COPD patients are characterized by a decreased muscle protein synthesis and an elevated myofibrillar protein breakdown. A substantial number of these patients, characterized by an enhanced systemic inflammatory response, fails to respond to nutritional therapy, which is of clinical relevance as weight gain to nutritional therapy is a significant, independent predictor of mortality in COPD.
In the present study, the acute protein anabolic effect of two high-quality milk protein supplements in COPD will be examined by comparing a hydrolyzed casein and whey protein meal. We make use of hydrolyzed proteins to correct for absorption differences. Furthermore the effects of these milk proteins with or without enrichment of leucine will be investigated.
Variables of interest are: net whole body protein synthesis; whole body protein synthesis and breakdown rate; whole body myofibrillar protein breakdown rate; whole body collagen breakdown; kinetics of insulin; glucose; amino acid levels.
It is the investigators hypothesis that a nutritional supplement containing casein protein and high levels of leucine will target the metabolic alterations of these cachectic COPD patients and will specifically stimulate protein anabolism. The knowledge gained from this study will benefit our insight in terms of promotion of protein anabolism in COPD patients. The long-term goal is to reformulate nutritional composition in accord with the effects of COPD on protein metabolism in order to ameliorate or even prevent progressive muscle wasting in these subjects, and improve their quality of life and survival rates.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Casein protein hydrolysates, Whey protein hydrolysates, Casein protein hydrolysates + LEU, Whey protein hydrolysates + LEU
- Keywords
- casein protein, whey protein, hydrolysates, leucine, protein metabolism, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casein protein hydrolysatesDietary supplement
Also called Casein
15 g casein protein hydrolysates + 15 g maltodextrin
Whey protein hydrolysatesDietary supplement
Also called Whey
15 g whey protein isolate + 15 g maltodextrin
Casein protein hydrolysates + LEUDietary supplement
Also called Casein + LEU
15 g casein protein hydrolysate + 2.1 g LEU (40% of EAA content) + 15 g maltodextrin
Whey protein hydrolysates + LEUDietary supplement
Also called Whey + LEU
15 g whey protein isolate + 1.5 g LEU (40% of EAA content) + 15 g maltodextrion
| Study group | Role | What they receive |
|---|---|---|
| Casein protein hydrolysates | Experimental | 15 g casein protein hydrolysates and 15 g maltodextrin Receives: Dietary Supplement: Casein protein hydrolysates |
| Whey protein hydrolysates | Experimental | 15 g whey protein hydrolysates and 15 g maltodextrin Receives: Dietary Supplement: Whey protein hydrolysates |
| Casein protein hydrolysates + LEU | Experimental | 15 g casein protein hydrolysates + 2.1 g LEU (40% of EAA content) + 15 g maltodextrin Receives: Dietary Supplement: Casein protein hydrolysates + LEU |
| Whey protein hydrolysates + LEU | Experimental | 15 g whey protein hydrolysates + 1.5 g LEU (40% of EAA content) + 15 g maltodextrin Receives: Dietary Supplement: Whey protein hydrolysates + LEU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in net whole body protein balance
Net whole body protein synthesis before and after protein feeding
Measured: 6 hours
Secondary outcomes (7)
Change in whole body protein synthesis rate
Whole body protein synthesis before and after protein feeding
Measured: 6 hours
Change in whole body protein breakdown rate
Whole body protein breakdown rate before and after protein feeding
Measured: 6 hours
Change in whole body collagen breakdown
Whole body collagen breakdown before and after protein feeding
Measured: 6 hours
Change in insulin concentration
Plasma insulin during protein feeding
Measured: 6 hours
Change in glucose concentration
Plasma glucose concentration during protein feeding
Measured: 6 hours
Change in plasma amino acid levels
Plasma amino acid level during protein feeding
Measured: 6 hours
Change in whole body myofibrillar protein breakdown rate
Whole body myofibrillar protein breakdown before and after protein feeding
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startMay 2009
- Primary completionJul 2011
- Study completionJul 2011
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 Chronic Obstructive Pulmonary DiseaseStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 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, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154400
- Sponsor's protocol ID
- 109237
- Status last verified
- Oct 2012
- First submitted
- 24 Jun 2010
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Engelen 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 37542951Jonker R, Deutz NE, Erbland ML, Anderson PJ, Engelen MP. Hydrolyzed casein and whey protein meals comparably stimulate net whole-body protein synthesis in COPD patients with nutritional depletion without an additional effect of leucine co-ingestion. Clin Nutr. 2014 Apr;33(2):211-20. doi: 10.1016/j.clnu.2013.06.014. Epub 2013 Jul 1.
PubMed 23886411
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grant Title: Eicosapentaenoic Acid and Protein Modulation to Induce Anabolism in COPD
- ClinicalTrials.gov ID
- NCT01154400
- Acronym / sponsor ID
- 109237
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- casein protein, whey protein, hydrolysates, leucine, protein metabolism, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Jun 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.
The aim of this study is the first aim of a NIH project that consists of 3 aims. The first aim examines the acute effects of two high-quality milk proteins (casein vs. whey) on whole-body and muscle protein metabolism in COPD patients with severe loss of muscle mass and the effects of adding leucine. The principal endpoints will be the extent of stimulation of net whole body protein synthesis as this is the principal mechanism by which either amino acid or protein intake causes muscle anabolism. After determining the optimal nutritional formulation based on the first aim we will continue to work on the second and third aim where fish oil supplementation will be part of the nutritional intervention as well.
Detailed description
Cachectic COPD patients are characterized by a decreased muscle protein synthesis and an elevated myofibrillar protein breakdown. A substantial number of these patients, characterized by an enhanced systemic inflammatory response, fails to respond to nutritional therapy, which is of clinical relevance as weight gain to nutritional therapy is a significant, independent predictor of mortality in COPD.
In the present study, the acute protein anabolic effect of two high-quality milk protein supplements in COPD will be examined by comparing a hydrolyzed casein and whey protein meal. We make use of hydrolyzed proteins to correct for absorption differences. Furthermore the effects of these milk proteins with or without enrichment of leucine will be investigated.
Variables of interest are: net whole body protein synthesis; whole body protein synthesis and breakdown rate; whole body myofibrillar protein breakdown rate; whole body collagen breakdown; kinetics of insulin; glucose; amino acid levels.
It is the investigators hypothesis that a nutritional supplement containing casein protein and high levels of leucine will target the metabolic alterations of these cachectic COPD patients and will specifically stimulate protein anabolism. The knowledge gained from this study will benefit our insight in terms of promotion of protein anabolism in COPD patients. The long-term goal is to reformulate nutritional composition in accord with the effects of COPD on protein metabolism in order to ameliorate or even prevent progressive muscle wasting in these subjects, and improve their quality of life and survival rates.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Casein protein hydrolysates | Experimental | Dietary Supplement: Casein protein hydrolysates15 g casein protein hydrolysates and 15 g maltodextrin |
| Whey protein hydrolysates | Experimental | Dietary Supplement: Whey protein hydrolysates15 g whey protein hydrolysates and 15 g maltodextrin |
| Casein protein hydrolysates + LEU | Experimental | Dietary Supplement: Casein protein hydrolysates + LEU15 g casein protein hydrolysates + 2.1 g LEU (40% of EAA content) + 15 g maltodextrin |
| Whey protein hydrolysates + LEU | Experimental | Dietary Supplement: Whey protein hydrolysates + LEU15 g whey protein hydrolysates + 1.5 g LEU (40% of EAA content) + 15 g maltodextrin |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of moderate to severe chronic airflow limitation, defined as measured forced expiratory volume in one second (FEV1) ≤ 70% of reference FEV1
- Shortness of breath on exertion
- Age 45 years and older
- Clinically stable condition and not suffering from 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) at least 4 weeks prior to the study
- Cachexia based on the criteria: Body mass index ≤ 25 kg/m2 and/or FFM-Index: FFM/height2 ≤ 17 (males), 15 (females) kg/m2 and/or recent involuntary weight loss
Key exclusion criteria (10 listed)
- Established diagnosis of malignancy
- Presence of fever within the last 3 days
- Established diagnosis of Diabetes Mellitus
- 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 |
|---|---|---|
| Casein protein hydrolysatesAlso: Casein15 g casein protein hydrolysates + 15 g maltodextrin | Dietary supplement | Casein protein hydrolysates |
| Whey protein hydrolysatesAlso: Whey15 g whey protein isolate + 15 g maltodextrin | Dietary supplement | Whey protein hydrolysates |
| Casein protein hydrolysates + LEUAlso: Casein + LEU15 g casein protein hydrolysate + 2.1 g LEU (40% of EAA content) + 15 g maltodextrin | Dietary supplement | Casein protein hydrolysates + LEU |
| Whey protein hydrolysates + LEUAlso: Whey + LEU15 g whey protein isolate + 1.5 g LEU (40% of EAA content) + 15 g maltodextrion | Dietary supplement | Whey protein hydrolysates + LEU |
Primary outcome
Change in net whole body protein balance
Time frame: 6 hours
Net whole body protein synthesis before and after protein feeding
7 secondary outcomes
Change in whole body protein synthesis rate
Time frame: 6 hours
Change in whole body protein breakdown rate
Time frame: 6 hours
Change in whole body collagen breakdown
Time frame: 6 hours
Change in insulin concentration
Time frame: 6 hours
Change in glucose concentration
Time frame: 6 hours
Change in plasma amino acid levels
Time frame: 6 hours
Change in whole body myofibrillar protein breakdown rate
Time frame: 6 hours
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 15 Oct 2012.
- 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 23886411Jonker R, Deutz NE, Erbland ML, Anderson PJ, Engelen MP. Hydrolyzed casein and whey protein meals comparably stimulate net whole-body protein synthesis in COPD patients with nutritional depletion without an additional effect of leucine co-ingestion. Clin Nutr. 2014 Apr;33(2):211-20. doi: 10.1016/j.clnu.2013.06.014. Epub 2013 Jul 1.
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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, 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 Casein protein hydrolysates, Whey protein hydrolysates and Casein protein hydrolysates + LEU in people with Chronic Obstructive Pulmonary Disease, 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 5 inclusion and 10 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 15 Oct 2012. 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 balance (time frame: 6 hours). 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 NCT01154400, 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 15 Oct 2012.