Chronic Obstructive Pulmonary DiseaseNCT01418469
Disturbances in BCAA Metabolism and the Effects of Feeding and Exercise in COPD
A study testing Caseinate, Whey protein isolate and Soy in people with Chronic Obstructive Pulmonary Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Studies on resting human muscle show that ingestion of the branched-chain amino acids (BCAA): leucine, valine and isoleucine have an anabolic effect on muscle protein metabolism. However, the effects of BCAA intake on protein metabolism during exercise are less clear. Read more about this study
- Who is it for?
- Ages 45 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Caseinate, Whey protein isolate and Soy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2002to Dec 2004
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Irreversible chronic airflow limitation (FEV1 <70% of predicted)
- Clinically stable condition
Who cannot join
- Oxygen supplementation
- Respiratory tract infection or exacerbation of his disease at least 4 weeks prior to the study
- Oral corticosteroids as maintenance medication
- Other concomitant metabolic disease (ie malignancy, cardiac failure, recent surgery, severe endocrine, hepatic or renal disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Exercise on the Metabolic Fate of Branched Chain Amino Acids in Relation to Aging and Chronic Disease.
Studies on resting human muscle show that ingestion of the branched-chain amino acids (BCAA): leucine, valine and isoleucine have an anabolic effect on muscle protein metabolism. However, the effects of BCAA intake on protein metabolism during exercise are less clear. When BCAA were supplied as single amino acids, without other amino acids and/or carbohydrates, no effects were observed on protein kinetics. On the other hand, ingestion of BCAA during running appeared to reduce the catabolic effect of running on muscle protein metabolism. These experiments were all performed with mixtures of the BCAA with or without carbohydrates but not in the form of complete meals with food protein as a basis. Therefore, it is still unknown whether a protein meal, containing a substantial amount of BCAA is beneficial during exercise by inducing an anabolic effect.
Whey and Casein protein contain a substantial amount of BCAA in contrast to Soy protein. Therefore, it is hypothesized that milk-based proteins are a better and more physiological source of BCAA during exercise and will lead to more protein anabolism. Most of the available studies have been carried out in young and fit humans but there are hardly any data are available in the increasing population of the elderly. Therefore it is still unknown whether a BCAA rich protein meal can enhance the anabolic effect of exercise in older individuals.
Besides sarcopenia, a substantial part of the elderly is suffering from a chronic systemic disease such as chronic obstructive pulmonary disease (COPD). COPD represents an important health care problem. COPD is the fourth leading cause of death and will be the third leading cause worldwide in 2020. Besides the local impairment, COPD is a chronic wasting disease, associated with alterations in intermediary metabolism. Substantial disturbances have been found in BCAA (and related) metabolism in these patients at rest and during exercise. It might therefore be of clinical relevance to study the metabolic effects of BCAA rich protein meals in patients with COPD at rest and during exercise.
Read the detailed description
In this study we investigate whether milk based protein sources of BCAA (casein and whey proteins) are superior to soy protein in the stimulation of protein anabolism before, during and after cycle exercise in COPD and healthy elderly and young subjects, and whether adding BCAA to soy protein will increase protein anabolism in these subjects.
To investigate Leucine, Isoleucine and Valine metabolism during and after exercise in COPD and healthy subjects
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Caseinate, Whey protein isolate, Soy, soy+BCAA
- Keywords
- COPD, protein metabolism, branched-chain amino acid metabolism, exercise, protein feeding
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaseinateDietary supplement
Also called casein
18 mg protein/kg body weight caseinate and 46 mg maltodextrin / kg body weight per 20 min sip feeding
Whey protein isolateDietary supplement
Also called Whey
18 mg protein/kg body weight whey protein isolate and 46 mg maltodextrin / kg body weight per 20 min sip feeding
SoyDietary supplement
18 mg protein/kg body weight soy and 46 mg maltodextrin / kg body weight per 20 min sip feeding
soy+BCAADietary supplement
18 mg protein/kg body weight soy+BCAA and 46 mg maltodextrin / kg body weight per 20 min sip feeding
| Study group | Role | What they receive |
|---|---|---|
| Caseinate protein intake | Experimental | 18 mg protein/kg body weight caseinate and 46 mg maltodextrin / kg body weight per 20 min sip feeding Receives: Dietary Supplement: Caseinate |
| Whey protein isolate intake | Experimental | 18 mg protein/kg body weight whey protein isolate and 46 mg maltodextrin / kg body weight per 20 min sip feeding Receives: Dietary Supplement: Whey protein isolate |
| Soy protein intake | Experimental | 18 mg protein/kg body weight soy and 46 mg maltodextrin / kg body weight per 20 min sip feeding Receives: Dietary Supplement: Soy |
| soy+BCAA protein intake | Experimental | 18 mg protein/kg body weight soy+BCAA and 46 mg maltodextrin / kg body weight per 20 min sip feeding Receives: Dietary Supplement: soy+BCAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Net whole body protein synthesis
Net whole body protein synthesis during protein feeding and the response to a 20 min cycle exercise bout
Measured: 6 hours
Secondary outcomes (9)
Change in whole body protein synthesis rate
Whole body protein synthesis rate during protein feeding and the response to 20 min cycle exercise bout
Measured: 6 hours
Change in Leucine turnover
Leucine turnover during protein feeding and the response to a 20 min cycle exercise bout
Measured: 6 hours
Change in Isoleucine turnover
Isoleucine turnover during protein feeding and the response to a 20 min cycle exercise bout
Measured: 6 hours
Change in Valine turnover
Valine turnover during protein feeding and the response to a 20 min cycle exercise bout
Measured: 6 hours
Change in plasma lactate concentration
Plasma lactate during protein feeding and the response to a 20 min cycle exercise bout
Measured: 6 hours
Change in NH3 concentration
Plasma NH3 during protein feeding and the response to a 20 min cycle exercise bout
Measured: 6 hours
Change in plasma amino acids concentrations
Plasma amino acid concentrations during protein feeding and the response to a 20 min cycle exercise bout
Measured: 6 hours
Splanchnic extraction of amino acids during protein feeding
Splanchnic extraction of amino acids during protein feeding and the response to a 20 min cycle exercise bout
Measured: 6 hours
Change in whole body protein breakdown rate
Whole body protein breakdown rate during protein feeding and the response to cycle exercise
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 posted17 Aug 2011 (estimated)
- Study startDec 2002
- Primary completionDec 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Dairy Association (EDA), Brussels
- Investigators
- Nicolaas EP Deutz, MD, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418469
- Sponsor's protocol ID
- MEC 02-059.3
- Status last verified
- Aug 2011
- First submitted
- 9 Aug 2011
- Last updated
- 17 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Engelen MP, Rutten EP, De Castro CL, Wouters EF, Schols AM, Deutz NE. Supplementation of soy protein with branched-chain amino acids alters protein metabolism in healthy elderly and even more in patients with chronic obstructive pulmonary disease. Am J Clin Nutr. 2007 Feb;85(2):431-9. doi: 10.1093/ajcn/85.2.431.
PubMed 17284740Engelen MP, Rutten EP, De Castro CL, Wouters EF, Schols AM, Deutz NE. Altered interorgan response to feeding in patients with chronic obstructive pulmonary disease. Am J Clin Nutr. 2005 Aug;82(2):366-72. doi: 10.1093/ajcn.82.2.366.
PubMed 16087980Engelen MP, De Castro CL, Rutten EP, Wouters EF, Schols AM, Deutz NE. Enhanced anabolic response to milk protein sip feeding in elderly subjects with COPD is associated with a reduced splanchnic extraction of multiple amino acids. Clin Nutr. 2012 Oct;31(5):616-24. doi: 10.1016/j.clnu.2012.04.006. Epub 2012 Jun 6.
PubMed 22682082Engelen MP, Rutten EP, De Castro CL, Wouters EF, Schols AM, Deutz NE. Casein protein results in higher prandial and exercise induced whole body protein anabolism than whey protein in chronic obstructive pulmonary disease. Metabolism. 2012 Sep;61(9):1289-300. doi: 10.1016/j.metabol.2012.03.001. Epub 2012 Apr 17.
PubMed 22512824
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise on the Metabolic Fate of Branched Chain Amino Acids in Relation to Aging and Chronic Disease.
- ClinicalTrials.gov ID
- NCT01418469
- Acronym / sponsor ID
- MEC 02-059.3
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, protein metabolism, branched-chain amino acid metabolism, exercise, protein feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- European Dairy Association (EDA), Brussels
- Study start
- Dec 2002
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 17 Aug 2011 (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.
Studies on resting human muscle show that ingestion of the branched-chain amino acids (BCAA): leucine, valine and isoleucine have an anabolic effect on muscle protein metabolism. However, the effects of BCAA intake on protein metabolism during exercise are less clear. When BCAA were supplied as single amino acids, without other amino acids and/or carbohydrates, no effects were observed on protein kinetics. On the other hand, ingestion of BCAA during running appeared to reduce the catabolic effect of running on muscle protein metabolism. These experiments were all performed with mixtures of the BCAA with or without carbohydrates but not in the form of complete meals with food protein as a basis. Therefore, it is still unknown whether a protein meal, containing a substantial amount of BCAA is beneficial during exercise by inducing an anabolic effect.
Whey and Casein protein contain a substantial amount of BCAA in contrast to Soy protein. Therefore, it is hypothesized that milk-based proteins are a better and more physiological source of BCAA during exercise and will lead to more protein anabolism. Most of the available studies have been carried out in young and fit humans but there are hardly any data are available in the increasing population of the elderly. Therefore it is still unknown whether a BCAA rich protein meal can enhance the anabolic effect of exercise in older individuals.
Besides sarcopenia, a substantial part of the elderly is suffering from a chronic systemic disease such as chronic obstructive pulmonary disease (COPD). COPD represents an important health care problem. COPD is the fourth leading cause of death and will be the third leading cause worldwide in 2020. Besides the local impairment, COPD is a chronic wasting disease, associated with alterations in intermediary metabolism. Substantial disturbances have been found in BCAA (and related) metabolism in these patients at rest and during exercise. It might therefore be of clinical relevance to study the metabolic effects of BCAA rich protein meals in patients with COPD at rest and during exercise.
Detailed description
In this study we investigate whether milk based protein sources of BCAA (casein and whey proteins) are superior to soy protein in the stimulation of protein anabolism before, during and after cycle exercise in COPD and healthy elderly and young subjects, and whether adding BCAA to soy protein will increase protein anabolism in these subjects.
To investigate Leucine, Isoleucine and Valine metabolism during and after exercise in COPD and healthy subjects
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Caseinate protein intake | Experimental | Dietary Supplement: Caseinate18 mg protein/kg body weight caseinate and 46 mg maltodextrin / kg body weight per 20 min sip feeding |
| Whey protein isolate intake | Experimental | Dietary Supplement: Whey protein isolate18 mg protein/kg body weight whey protein isolate and 46 mg maltodextrin / kg body weight per 20 min sip feeding |
| Soy protein intake | Experimental | Dietary Supplement: Soy18 mg protein/kg body weight soy and 46 mg maltodextrin / kg body weight per 20 min sip feeding |
| soy+BCAA protein intake | Experimental | Dietary Supplement: soy+BCAA18 mg protein/kg body weight soy+BCAA and 46 mg maltodextrin / kg body weight per 20 min sip feeding |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Irreversible chronic airflow limitation (FEV1 <70% of predicted)
- Clinically stable condition
Key exclusion criteria (4 listed)
- Oxygen supplementation
- Respiratory tract infection or exacerbation of his disease at least 4 weeks prior to the study
- Oral corticosteroids as maintenance medication
- Other concomitant metabolic disease (ie malignancy, cardiac failure, recent surgery, severe endocrine, 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 |
|---|---|---|
| CaseinateAlso: casein18 mg protein/kg body weight caseinate and 46 mg maltodextrin / kg body weight per 20 min sip feeding | Dietary supplement | Caseinate protein intake |
| Whey protein isolateAlso: Whey18 mg protein/kg body weight whey protein isolate and 46 mg maltodextrin / kg body weight per 20 min sip feeding | Dietary supplement | Whey protein isolate intake |
| Soy18 mg protein/kg body weight soy and 46 mg maltodextrin / kg body weight per 20 min sip feeding | Dietary supplement | Soy protein intake |
| soy+BCAA18 mg protein/kg body weight soy+BCAA and 46 mg maltodextrin / kg body weight per 20 min sip feeding | Dietary supplement | soy+BCAA protein intake |
Primary outcome
Change in Net whole body protein synthesis
Time frame: 6 hours
Net whole body protein synthesis during protein feeding and the response to a 20 min cycle exercise bout
9 secondary outcomes
Change in whole body protein synthesis rate
Time frame: 6 hours
Change in Leucine turnover
Time frame: 6 hours
Change in Isoleucine turnover
Time frame: 6 hours
Change in Valine turnover
Time frame: 6 hours
Change in plasma lactate concentration
Time frame: 6 hours
Change in NH3 concentration
Time frame: 6 hours
Change in plasma amino acids concentrations
Time frame: 6 hours
Splanchnic extraction of amino acids during protein feeding
Time frame: 6 hours
Change in whole body 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 17 Aug 2011.
- Results publication: PubMed 17284740Engelen MP, Rutten EP, De Castro CL, Wouters EF, Schols AM, Deutz NE. Supplementation of soy protein with branched-chain amino acids alters protein metabolism in healthy elderly and even more in patients with chronic obstructive pulmonary disease. Am J Clin Nutr. 2007 Feb;85(2):431-9. doi: 10.1093/ajcn/85.2.431.
- Results publication: PubMed 16087980Engelen MP, Rutten EP, De Castro CL, Wouters EF, Schols AM, Deutz NE. Altered interorgan response to feeding in patients with chronic obstructive pulmonary disease. Am J Clin Nutr. 2005 Aug;82(2):366-72. doi: 10.1093/ajcn.82.2.366.
- Derived from this study: PubMed 22682082Engelen MP, De Castro CL, Rutten EP, Wouters EF, Schols AM, Deutz NE. Enhanced anabolic response to milk protein sip feeding in elderly subjects with COPD is associated with a reduced splanchnic extraction of multiple amino acids. Clin Nutr. 2012 Oct;31(5):616-24. doi: 10.1016/j.clnu.2012.04.006. Epub 2012 Jun 6.
- Derived from this study: PubMed 22512824Engelen MP, Rutten EP, De Castro CL, Wouters EF, Schols AM, Deutz NE. Casein protein results in higher prandial and exercise induced whole body protein anabolism than whey protein in chronic obstructive pulmonary disease. Metabolism. 2012 Sep;61(9):1289-300. doi: 10.1016/j.metabol.2012.03.001. Epub 2012 Apr 17.
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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.
Nicolaas EP Deutz, MD, 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 Caseinate, Whey protein isolate and Soy in people with Chronic Obstructive Pulmonary Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 inclusion and 4 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 17 Aug 2011. 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 Netherlands. 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: 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 NCT01418469, which also lists 4 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 17 Aug 2011.