Casein Protein and Leucine Supplementation in Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- COPD
- Interventions
- Dietary Supplement: Hydrolyzed casein protein + carbohydratesDietary Supplement: Hydrolyzed casein protein + carbohydrates + leucineDietary Supplement: 4 levels of hydrolyzed casein protein + carbohydratesDietary Supplement: Hydrolyzed casein proteinDietary Supplement: Hydrolyzed casein protein + leucine
- Registration Number
- NCT01734473
- Lead Sponsor
- Texas A&M University
- Brief Summary
Weight loss commonly occurs in patients with COPD, negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of this weight loss and independently increases mortality. This study will provide relevant clinical information in regards to the anabolic properties of specific dietary substrates and their co-active anabolic effects. Hypotheses: 1) That supplementation of a hydrolyzed casein-based protein meal with the addition of carbohydrates is more anabolic than a hydrolyzed casein-based protein meal without carbohydrates in COPD patients and healthy older adults; 2) That leucine addition to a hydrolyzed casein-based protein meal only enhances the protein anabolic response in COPD patients and healthy older adults when carbohydrates are not added to the protein meal; 3) That COPD patients have a more efficient protein anabolic response to a hydrolyzed casein-based protein meal than healthy older adults.
A fifth study day was added to measure protein requirements of included individuals to be able to interpret their response to the other interventions on the other study days, and to test the hypothesis that subjects with lower protein requirements respond less to intervention with leucine and/or carbohydrates. For the 5th additional test day we will first approach the 10 COPD and 10 healthy subjects who already completed the first 4 study days (and signed the re-contact form) to come back for this extra test day. We will (pre-)screen these subjects by phone for eligibility and check for changes in their recent medical history (with help of the (pre-)screening questionnaires in CRF). If all inclusion criteria are still met, these subjects will be asked to provide a written re-consent. If necessary, we will recruit new subjects who will complete only one of the four test days (i.e. the test day on which the hydrolyzed casein-based protein meal with carbohydrates is provided) and the additional 5th study day.
- Detailed Description
The study involves 5 study days. The duration of the first 4 study days is approximately 6.5 hours per day and the duration of the 5th study day is approximately 8 hours. On each of the first 4 study days the effect a casein protein meal with or without leucine and carbohydrates will be examined. On the fifth study day the effect of 4 different levels of casein protein and carbohydrate intake by sip feeding (every 20 minutes) is examined.
Also, subjects will receive a mixture of amino acids (little parts of protein) which are a little bit heavier than normal, called stable isotopes. This is the so-called stable isotope method to investigate protein behavior in the body (protein kinetics). Altogether about 75 ml of blood will be drawn per study day to assess outcome measures.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Study day 2 Hydrolyzed casein protein + carbohydrates Hydrolyzed casein protein + carbohydrates. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order. Study day 4 Hydrolyzed casein protein + carbohydrates + leucine Hydrolyzed casein protein + carbohydrates + leucine. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order. Study Day 5 4 levels of hydrolyzed casein protein + carbohydrates 4 levels of hydrolyzed casein protein + carbohydrates Study day 1 Hydrolyzed casein protein Hydrolyzed casein protein. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order. Study day 3 Hydrolyzed casein protein + leucine Hydrolyzed casein protein + leucine. On each study day participants receive one out of 4 protein meals (interventions). The 4 interventions are given in a randomized order.
- Primary Outcome Measures
Name Time Method Net whole-body protein synthesis with different levels of protein intake (Fifth Study Day) before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min) Change in net whole-body protein synthesis (whole-body protein synthesis - whole-body protein breakdown) with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Net whole-body protein synthesis 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal Change in net whole-body protein synthesis (whole-body protein synthesis - whole-body protein breakdown)
- Secondary Outcome Measures
Name Time Method Whole-body protein synthesis 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal Change in whole-body protein synthesis
Inflammatory mediators 90 min before protein meal C-reactive protein, interleukines
Whole-body protein breakdown 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal Change in whole-body protein breakdown
Splanchnic extraction 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal The amount of amino acids in the protein meal extracted by the splanchnic tissues after intake
Body composition 1 day Difference in muscle mass, fat mass and bone density between COPD patients and healthy older adults
Whole-body protein synthesis with different levels of protein intake (Fifth Study Day) before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min) Change in whole-body protein synthesis with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Whole-body protein breakdown with different levels of protein intake (Fifth Study Day) before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min) Change in whole-body protein breakdown with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Glucose 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal Peak plasma concentration (Cmax) of glucose
Amino acid concentrations 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal Peak plasma concentration (Cmax) of amino acids
Hormones with different levels of protein intake (Fifth Study Day) before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min) Area under the plasma concentration versus time curve (AUC) of insulin with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Glucose with different levels of protein intake (Fifth Study Day) before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min) Peak plasma concentration (Cmax) of glucose with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Amino acid concentrations with different levels of protein intake (Fifth Study Day) before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min) Peak plasma concentration (Cmax) of amino acids with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Skeletal and respiratory muscle strength 1 day Difference in handgrip strength and fatigue and maximum inspiratory and expiratory pressure between COPD patients and healthy older adults
Hormones 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal Area under the plasma concentration versus time curve (AUC) of insulin
Splanchnic extraction with different levels of protein intake (Fifth Study Day) before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min) The amount of amino acids in the protein meal extracted by the splanchnic tissues after intake of 4 different levels of protein (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Trial Locations
- Locations (1)
Texas A&M University
🇺🇸College Station, Texas, United States