Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094562
Status:
COMPLETED
Last Update Posted:
2019-01-18
First Post:
2004-10-20
Brief Title:
A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
AAFA Fish Oil Nutritional Supplementation to Maintain Body Weight in Patients With Disease-Related Weight Loss
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of fish oil supplements in maintaining weight in people with disease-related weight loss andor cachexia
Detailed Description:
The overall goal of this project is to evaluate the safety and efficacy of nutritional supplementation with fish oils to maintain weight in patients with disease-related weight loss cachexia Weight loss commonly results in a poorer prognosis functional status and quality of life Despite the high morbidity and mortality associated with cachexia mainstream treatment does not sustain weight and although nutritional supplements are commonly used many of these have not been tested in clinical trials Recent work in cachexia has revealed that this is mediated by pro-inflammatory cytokines There are data that suggests that fish oils can affect the underlying pathogenic inflammatory response and have an affect on weight maintenance and nutritional balance
Diseases in which cachexia is most common
Cancer
Chronic Heart Failure CHF
Chronic Obstructive Pulmonary Disease COPD
Rheumatoid Arthritis RA
Goals of the Study
To evaluate the safety and efficacy of fish oils vs corn oil in the maintenance of weight and lean body mass in patients with disease-related weight loss
To understand the mechanism of fish oil effect on health maintenance by evaluating the anti-inflammatory anti-catabolic anti-oxidant and anabolic actions of these compounds
To document the effect of our interventions on quality of life and functional status
Study Outline
Participants will be randomly assigned to receive either fish oil supplements or corn oil for the duration of this 3-month study Participants will have five study visits and two telephone interviews During each study visit participants will undergo laboratory tests a physical exam and a dual energy X-ray absorptiometry DEXA bone scan Participants will be asked to keep a food diary during the study During the telephone interviews participants will be asked health-related questions and discuss their current functional status
Diseases in which cachexia is most common
Cancer
Chronic Heart Failure CHF
Chronic Obstructive Pulmonary Disease COPD
Rheumatoid Arthritis RA
Goals of the Study
To evaluate the safety and efficacy of fish oils vs corn oil in the maintenance of weight and lean body mass in patients with disease-related weight loss
To understand the mechanism of fish oil effect on health maintenance by evaluating the anti-inflammatory anti-catabolic anti-oxidant and anabolic actions of these compounds
To document the effect of our interventions on quality of life and functional status
Study Outline
Participants will be randomly assigned to receive either fish oil supplements or corn oil for the duration of this 3-month study Participants will have five study visits and two telephone interviews During each study visit participants will undergo laboratory tests a physical exam and a dual energy X-ray absorptiometry DEXA bone scan Participants will be asked to keep a food diary during the study During the telephone interviews participants will be asked health-related questions and discuss their current functional status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50AT000437 | NIH | JHM IRB | httpsreporternihgovquickSearchP50AT000437 |
| 03-02-10-12 | OTHER | None | None |