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Hydrolyzed Casein and Whey Protein Supplementation and the Addition of Leucine to Induce Protein Anabolism in Malnourished COPD Patients

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ClinicalTrials.gov Identifier: NCT01154400
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : October 15, 2012
Sponsor:
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University

Tracking Information
First Submitted Date  ICMJE June 24, 2010
First Posted Date  ICMJE June 30, 2010
Last Update Posted Date October 15, 2012
Study Start Date  ICMJE May 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
Change in net whole body protein balance [ Time Frame: 6 hours ]
Net whole body protein synthesis before and after protein feeding
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
Net whole body protein balance [ Time Frame: Up to 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
  • Change in whole body protein synthesis rate [ Time Frame: 6 hours ]
    Whole body protein synthesis before and after protein feeding
  • Change in whole body protein breakdown rate [ Time Frame: 6 hours ]
    Whole body protein breakdown rate before and after protein feeding
  • Change in whole body collagen breakdown [ Time Frame: 6 hours ]
    Whole body collagen breakdown before and after protein feeding
  • Change in insulin concentration [ Time Frame: 6 hours ]
    Plasma insulin during protein feeding
  • Change in glucose concentration [ Time Frame: 6 hours ]
    Plasma glucose concentration during protein feeding
  • Change in plasma amino acid levels [ Time Frame: 6 hours ]
    Plasma amino acid level during protein feeding
  • Change in whole body myofibrillar protein breakdown rate [ Time Frame: 6 hours ]
    Whole body myofibrillar protein breakdown before and after protein feeding
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
  • Whole body protein synthesis and breakdown rate [ Time Frame: Up to 2 years ]
  • Whole body myofibrillar protein breakdown rate [ Time Frame: Up to 2 years ]
  • Whole body collagen breakdown [ Time Frame: Up to 2 years ]
  • Kinetics of insulin [ Time Frame: Up to 2 years ]
  • Kinetics of glucose [ Time Frame: Up to 2 years ]
  • Amino acid levels [ Time Frame: Up to 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hydrolyzed Casein and Whey Protein Supplementation and the Addition of Leucine to Induce Protein Anabolism in Malnourished COPD Patients
Official Title  ICMJE Grant Title: Eicosapentaenoic Acid and Protein Modulation to Induce Anabolism in COPD
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Dietary Supplement: Casein protein hydrolysates
    15 g casein protein hydrolysates + 15 g maltodextrin
    Other Name: Casein
  • Dietary Supplement: Whey protein hydrolysates
    15 g whey protein isolate + 15 g maltodextrin
    Other Name: Whey
  • Dietary Supplement: Casein protein hydrolysates + LEU
    15 g casein protein hydrolysate + 2.1 g LEU (40% of EAA content) + 15 g maltodextrin
    Other Name: Casein + LEU
  • Dietary Supplement: Whey protein hydrolysates + LEU
    15 g whey protein isolate + 1.5 g LEU (40% of EAA content) + 15 g maltodextrion
    Other Name: Whey + LEU
Study Arms  ICMJE
  • Experimental: Casein protein hydrolysates
    15 g casein protein hydrolysates and 15 g maltodextrin
    Intervention: Dietary Supplement: Casein protein hydrolysates
  • Experimental: Whey protein hydrolysates
    15 g whey protein hydrolysates and 15 g maltodextrin
    Intervention: Dietary Supplement: Whey protein hydrolysates
  • Experimental: Casein protein hydrolysates + LEU
    15 g casein protein hydrolysates + 2.1 g LEU (40% of EAA content) + 15 g maltodextrin
    Intervention: Dietary Supplement: Casein protein hydrolysates + LEU
  • Experimental: Whey protein hydrolysates + LEU
    15 g whey protein hydrolysates + 1.5 g LEU (40% of EAA content) + 15 g maltodextrin
    Intervention: Dietary Supplement: Whey protein hydrolysates + LEU
Publications * Jonker 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2012)
12
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2010)
27
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01154400
Other Study ID Numbers  ICMJE 109237
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marielle PKJ Engelen, PhD, Texas A&M University
Study Sponsor  ICMJE Texas A&M University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marielle Engelen, PhD Texas A&M University
PRS Account Texas A&M University
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP