Back to resultsOmega-3 Fatty Acid Supplementation in Older Adults
Primary Purpose
Inflammation
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 fatty acid
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Inflammation focused on measuring Omega-3 fatty acid, Fish oil, Muscle mass, Muscle strength, Older adults, Circulating inflammatory cytokines, Skeletal muscle mass, Upper body strength, Lower body strength
Eligibility Criteria
Inclusion Criteria:
- 60 years of age or over
Exclusion Criteria:
- Fish, seafood allergies, nut allergies, soy allergies
- Habitual (>1/week) fish or seafood consumption
- Current Omega-3 supplement use
- Gastrointestinal problems
- Current anti-inflammatory medication use
- Current anticoagulant medication use
Sites / Locations
- Department of Health and Sport Sciences, The University of Memphis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fish oil (Omega-3 fatty acid)
Soybean oil
Arm Description
2 capsules/day of ProOmega providing 650mg EPA and 450mg DHA
2 capsules/day
Outcomes
Primary Outcome Measures
C-Reactive protein
Inflammatory marker
IL6
Inflammatory cytokine
TNFα
Inflammatory cytokine
Secondary Outcome Measures
Skeletal muscle mass/body composition
The amount of skeletal muscle mass and fat mass and their ration will be determined.
Lower body muscular strength
Measurement of maximum strength in the leg press exercise
Upper body muscular strength
Measurement of maximum strength in the chest press exercise
Full Information
NCT ID
NCT01666392
First Posted
August 10, 2012
Last Updated
October 8, 2012
Sponsor
University of Memphis
Collaborators
Nordic Naturals
1. Study Identification
Unique Protocol Identification Number
NCT01666392
Brief Title
Omega-3 Fatty Acid Supplementation in Older Adults
Official Title
The Impact of Omega-3 Fatty Acid Supplementation on Markers of Inflammation and Lean Body Mass in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Withdrawn
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Memphis
Collaborators
Nordic Naturals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study to determine whether Fish oil (Omega-3 Fatty Acid) supplementation has an impact on inflammation and lean body mass in older adults. The investigators expect that Fish oil supplementation will reduce inflammation and prevent the loss of lean mass compared to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Omega-3 fatty acid, Fish oil, Muscle mass, Muscle strength, Older adults, Circulating inflammatory cytokines, Skeletal muscle mass, Upper body strength, Lower body strength
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fish oil (Omega-3 fatty acid)
Arm Type
Experimental
Arm Description
2 capsules/day of ProOmega providing 650mg EPA and 450mg DHA
Arm Title
Soybean oil
Arm Type
Placebo Comparator
Arm Description
2 capsules/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acid
Other Intervention Name(s)
ProOmega (Nordic Naturals)
Intervention Description
Omega-3 fatty acid, Eicosapentaenoic acid+docosahexaenoic acid in capsule form
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
C-Reactive protein
Description
Inflammatory marker
Time Frame
At baseline testing and at 3 month endpoint
Title
IL6
Description
Inflammatory cytokine
Time Frame
At baseline and at 3 month endpoint
Title
TNFα
Description
Inflammatory cytokine
Time Frame
At baseline and at 3 month endpoint
Secondary Outcome Measure Information:
Title
Skeletal muscle mass/body composition
Description
The amount of skeletal muscle mass and fat mass and their ration will be determined.
Time Frame
At baseline testing and at 3 month endpoint
Title
Lower body muscular strength
Description
Measurement of maximum strength in the leg press exercise
Time Frame
At baseline and at 3 month endpoint
Title
Upper body muscular strength
Description
Measurement of maximum strength in the chest press exercise
Time Frame
At baseline and at 3 month endpoint
Other Pre-specified Outcome Measures:
Title
EPA and DHA
Description
To determine the effectiveness of fish oil supplementation, we measure EPA and DHA Omega-3 fatty acid levels
Time Frame
At baseline and at 3 month endpoint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
60 years of age or over
Exclusion Criteria:
Fish, seafood allergies, nut allergies, soy allergies
Habitual (>1/week) fish or seafood consumption
Current Omega-3 supplement use
Gastrointestinal problems
Current anti-inflammatory medication use
Current anticoagulant medication use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zsolt Murlasits, Ph.D.
Organizational Affiliation
The University of Memphis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Health and Sport Sciences, The University of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38152
Country
United States
12. IPD Sharing Statement
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Omega-3 Fatty Acid Supplementation in Older Adults
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