Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01418469
Other study ID # MEC 02-059.3
Secondary ID
Status Completed
Phase N/A
First received August 9, 2011
Last updated August 16, 2011
Start date December 2002
Est. completion date December 2004

Study information

Verified date August 2011
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 2004
Est. primary completion date December 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 45 Years and older
Eligibility Inclusion Criteria:

- Irreversible chronic airflow limitation (FEV1 <70% of predicted)

- Clinically stable condition

Exclusion Criteria:

- 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Caseinate
18 mg protein/kg body weight caseinate and 46 mg maltodextrin / kg body weight per 20 min sip feeding
Whey protein isolate
18 mg protein/kg body weight whey protein isolate and 46 mg maltodextrin / kg body weight per 20 min sip feeding
Soy
18 mg protein/kg body weight soy and 46 mg maltodextrin / kg body weight per 20 min sip feeding
soy+BCAA
18 mg protein/kg body weight soy+BCAA and 46 mg maltodextrin / kg body weight per 20 min sip feeding

Locations

Country Name City State
Netherlands Maastricht UMC Maastricht

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center European Dairy Association (EDA), Brussels

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Engelen 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. — View Citation

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 Cl — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 hours No
Secondary Change in whole body protein synthesis rate Whole body protein synthesis rate during protein feeding and the response to 20 min cycle exercise bout 6 hours No
Secondary Change in Leucine turnover Leucine turnover during protein feeding and the response to a 20 min cycle exercise bout 6 hours No
Secondary Change in Isoleucine turnover Isoleucine turnover during protein feeding and the response to a 20 min cycle exercise bout 6 hours No
Secondary Change in Valine turnover Valine turnover during protein feeding and the response to a 20 min cycle exercise bout 6 hours No
Secondary Change in plasma lactate concentration Plasma lactate during protein feeding and the response to a 20 min cycle exercise bout 6 hours No
Secondary Change in NH3 concentration Plasma NH3 during protein feeding and the response to a 20 min cycle exercise bout 6 hours No
Secondary Change in plasma amino acids concentrations Plasma amino acid concentrations during protein feeding and the response to a 20 min cycle exercise bout 6 hours No
Secondary 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 6 hours No
Secondary Change in whole body protein breakdown rate Whole body protein breakdown rate during protein feeding and the response to cycle exercise 6 hours No
See also
  Status Clinical Trial Phase
Completed NCT05102305 - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed NCT01867762 - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Phase 2
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03089515 - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust N/A
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT05552833 - Pulmonary Adaptive Responses to HIIT in COPD N/A
Recruiting NCT05835492 - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Completed NCT03244137 - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT03282526 - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease N/A
Completed NCT02546700 - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Withdrawn NCT04446637 - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD Phase 3
Completed NCT04535986 - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT03256695 - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Withdrawn NCT04042168 - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT03414541 - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02552160 - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy