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Polyunsaturated Fatty Acid

Healthy older adults for Chronic Obstructive Pulmonary Disease

N/A
Waitlist Available
Led By Marielle Engelen, PhD
Research Sponsored by Texas A&M University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on study day 1 and the change from study day 1 on study day 2
Awards & highlights

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 increase the anabolic response even further. In the present study both the acute and chronic effects of EPA+DHA versus a placebo on muscle and whole body protein metabolism will be examined. The principal endpoint will be the extent of stimulation of net fractional muscle protein synthesis as this is the principal mechanism by which the effect of EPA+DHA on muscle anabolism can be measured. The endpoint will be assessed by isotope methodology which is thought to be the reference method.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease
  • Muscle Wasting

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on study day 1 and the change from study day 1 on study day 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and on study day 1 and the change from study day 1 on study day 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fractional muscle protein synthesis and breakdown rate (FSR and FBR) of mixed muscle protein (%/h) and net fractional muscle protein synthesis (nFSR = FSR - FBR)
Secondary outcome measures
Body composition
Glutathione turnover
Inflammatory profile (CRP, IL6, IL1b, TNFα, IL8 and IL10)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Healthy older adultsExperimental Treatment2 Interventions
Healthy controls will receive each intervention (olive oil or fish oil with 3.5 g EPA+DHA) one time and for only one day per intervention .
Group II: COPD patientsExperimental Treatment3 Interventions
COPD patients will receive one out of three possible interventions (olive oil or fish oil with 3.5 g EPA+DHA or fish oil and placebo with 2 g EPA+DHA) for 4 (+/- 7 days) weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olive oil
2014
Completed Phase 4
~7210
Fish oil
2014
Completed Phase 4
~1830

Find a Location

Who is running the clinical trial?

Texas A&M UniversityLead Sponsor
140 Previous Clinical Trials
24,293 Total Patients Enrolled
Marielle Engelen, PhDPrincipal InvestigatorTexas A&M University
6 Previous Clinical Trials
272 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby May 2025