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NCT01624792 · ClinicalTrials.gov registry record · NA
Eicosapentaenoic Acid and Protein Modulation to Induce Anabolism in Chronic Obstructive Pulmonary Disease (COPD): Aim 2
A NA study, sponsored by Texas A&M University.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
NCT01624792 is a NA study that has completed, run by Texas A&M University. The registered enrollment target is 64 participants.
The verdict
NCT01624792, a NA study, has completed, sponsored by Texas A&M University.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
Study Summary
Loss of muscle protein is generally a central component of weight loss in Chronic Obstructive Pulmonary Disease (COPD) patients. Gains in muscle mass are difficult to achieve in COPD unless specific metabolic abnormalities are targeted. The investigators recently observed that alterations in protein metabolism are present in normal weight COPD patients. Elevated levels of protein synthesis and breakdown rates were found in this COPD group indicating that alterations are already present before muscle wasting occurs. The investigators recently observed that in order to enhance protein anabolism, manipulation of the composition of proteins and amino acids in nutrition is required in normal-weight COPD. Intake of casein protein resulted into significant protein anabolism in these patients. The anabolic response to casein protein was even higher than after whey protein intake. A substantial number of COPD patients, underweight as well as normal weight to obese, is characterized by an increased inflammatory response. This group failed to respond to nutritional therapy. Previous experimental research and clinical studies in cachectic conditions (mostly malignancy) indicate that polyunsaturated fatty acids (PUFA) are able to attenuate protein degradation by improving the anabolic response to feeding and by decreasing the acute phase response. Eicosapentaenoic acid (EPA) (in combination with docosahexaenoic acid (DHA)) has been shown to effectively inhibit weight loss in several disease states, however weight and muscle mass gain was not present or minimal. Until now, limited research has been done examining muscle protein metabolism and the response to EPA and DHA supplementation in patients with COPD. It is the investigator's hypothesis that supplementation of 2g/day EPA+DHA in COPD patients during 4 consecutive weeks will increase the muscle anabolic response to a high quality protein supplement as compared to a placebo, and supplementation of 3.5g/day EPA+DHA will inc
Interventions
- DIETARY_SUPPLEMENT Fish oil
- DIETARY_SUPPLEMENT Olive oil
- DIETARY_SUPPLEMENT Fish oil and placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2011-10-25 |
| Est. Completion | 2016-06-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01624792
The ClinicalTrials.gov registry entry for NCT01624792 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas A&M University, which has 95 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Fish oil is the first listed.
NCT01624792 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01624792 about?
NCT01624792 is a clinical study titled "Eicosapentaenoic Acid and Protein Modulation to Induce Anabolism in Chronic Obstructive Pulmonary Disease (COPD): Aim 2". Loss of muscle protein is generally a central component of weight loss in Chronic Obstructive Pulmonary Disease (COPD) patients. Gains in muscle mass are difficult to achieve in COPD unless specific metabolic abnormalities are targeted. The investigators recently observed that alterations in protein...
What is the current status of trial NCT01624792?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2011-10-25. Estimated completion is 2016-06-29.
What interventions are being tested in trial NCT01624792?
The interventions under investigation include: Fish oil (DIETARY_SUPPLEMENT), Olive oil (DIETARY_SUPPLEMENT), Fish oil and placebo (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01624792?
This trial is sponsored by Texas A&M University, which has 95 total clinical trials registered on ClinicalTrials.gov.
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