Hydrolyzed Casein and Whey Protein Supplementation and the Addition of Leucine to Induce Protein Anabolism in Malnourished COPD Patients
Grant Title: Eicosapentaenoic Acid and Protein Modulation to Induce Anabolism in COPD
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease
Started May 2009
Typical duration for not_applicable chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 24, 2010
CompletedFirst Posted
Study publicly available on registry
June 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedOctober 15, 2012
October 1, 2012
2.2 years
June 24, 2010
October 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in net whole body protein balance
Net whole body protein synthesis before and after protein feeding
6 hours
Secondary Outcomes (7)
Change in whole body protein synthesis rate
6 hours
Change in whole body protein breakdown rate
6 hours
Change in whole body collagen breakdown
6 hours
Change in insulin concentration
6 hours
Change in glucose concentration
6 hours
- +2 more secondary outcomes
Study Arms (4)
Casein protein hydrolysates
EXPERIMENTAL15 g casein protein hydrolysates and 15 g maltodextrin
Whey protein hydrolysates
EXPERIMENTAL15 g whey protein hydrolysates and 15 g maltodextrin
Casein protein hydrolysates + LEU
EXPERIMENTAL15 g casein protein hydrolysates + 2.1 g LEU (40% of EAA content) + 15 g maltodextrin
Whey protein hydrolysates + LEU
EXPERIMENTAL15 g whey protein hydrolysates + 1.5 g LEU (40% of EAA content) + 15 g maltodextrin
Interventions
15 g casein protein hydrolysates + 15 g maltodextrin
15 g whey protein isolate + 15 g maltodextrin
15 g casein protein hydrolysate + 2.1 g LEU (40% of EAA content) + 15 g maltodextrin
15 g whey protein isolate + 1.5 g LEU (40% of EAA content) + 15 g maltodextrion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Related Publications (2)
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.
PMID: 37542951DERIVEDJonker 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.
PMID: 23886411DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marielle Engelen, PhD
Texas A&M University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
June 24, 2010
First Posted
June 30, 2010
Study Start
May 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
October 15, 2012
Record last verified: 2012-10