- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02617511
Omega-3 Supplementation and Resistance Training
Omega-3 Fatty Acid Supplementation and Resistance Training on Inflammation and Body Composition in Older Men
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Summary: Sarcopenia is a prevalent health concern for many older individuals and finding strategies to ameliorate and reduce the loss of skeletal muscle mass and strength is deemed important for maintaining functional ability and independence as individual's age. Currently, resistance training is considered the standard of care for inducing an anabolic stimulus and preserving as well as enhancing muscle mass and strength in aged individuals. One mechanism whereby older adults seem to lose muscle mass with age is via chronic low grade inflammation. Finding complementary strategies to reduce inflammation, while at the same time building skeletal muscle mass and strength, is considered essential for combating the increased prevalence of sarcopenia observed as the population ages. Using nutritional supplementation strategies, such as omega-3 fatty acids, seems to provide an effect in not only reducing inflammation but also acting as an anabolic stimulus for skeletal muscle growth. It is not known whether or not providing omega-3 fatty acids (in the form of EPA/DHA supplementation) along with resistance training will result in a greater increase in skeletal muscle mass and strength than resistance training alone in an older population.
Hypotheses: The primary hypothesis of this research project is that omega-3 fatty acid supplementation and resistance training for 12 weeks will decrease markers of inflammation more so than resistance training and placebo in a cohort of older adults. A secondary hypothesis of the project is that omega-3 fatty acid supplementation and resistance training for 12 weeks will provide for a greater increase in skeletal muscle mass, strength, and functional ability than resistance training and placebo in a cohort of older adults.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3T2N2
- Applied Research Centre, Faculty of Kinesiology, University of Manitoba
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- equal to or greater than 65 years of age,
- male,
- they will not participate in a structured exercise program any more than 2-times per week.
Exclusion Criteria:
- consumption of anti-inflammatory medication (which would confound the results in terms of the effects that the exercise and nutritional intervention is accomplishing),
- diagnosis with an inflammatory disease (such as inflammatory bowel disease or rheumatoid arthritis) as this is not the participant population we want to evaluate,
- consumption of any natural health products that have anti-inflammatory components to them (such as omega-3 fatty acids or omega-3 fortified eggs or more than 2 servings per week of fatty fish),
- current participation in an exercise program ≥ 2 times per week or current participation in a structured resistance training program > 1 time per week as we want to evaluate an untrained, sedentary population,
- has a mental or cognitive disability (such as dementia), and
- has a physical disability that would limit them from participating in a structured resistance training program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omega-3 Supplementation
This groups will supplement their regular diet with 2.97 grams of combined omega-3 fatty acid (EPA/DHA) supplement in soft gel form on a daily basis for 12 weeks.
This group will also complete a whole body progressive resistance training program 3 days per week for 12 weeks.
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Other Names:
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Placebo Comparator: Placebo
This group will supplement their regular diet with 3.0 grams of a combined omega-3-6-9 supplement in soft gel form on a daily basis for 12 weeks.
This group will also complete a whole body progressive resistance training program 3 days per week for 12 weeks.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor Necrosis Factor-alpha
Time Frame: 12 weeks
|
The cytokine tumor necrosis factor-alpha will be used as the primary outcome to assess change in inflammatory status over the 12 week intervention
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interleukin-6
Time Frame: 12 weeks
|
Interleukin-6 will be used to assess changes in inflammatory status.
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12 weeks
|
Leg Press Strength
Time Frame: 12 weeks
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A one-repetition maximum leg press strength test will be used to assess lower body strength.
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12 weeks
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Lean Tissue Mass
Time Frame: 12 weeks
|
Dual energy x-ray absorptiometry will be used to assess changes in lean tissue mass.
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12 weeks
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Timed up and go Test
Time Frame: 12 weeks
|
Mobility and balance will be assessed using a 3 meter timed up and go test.
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12 weeks
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Bone Mineral Content
Time Frame: 12 weeks
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Dual energy x-ray absorptiometry will be used to assess changes in bone mass.
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12 weeks
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Chest Press Strength
Time Frame: 12 week
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A one-repetition maximum chest press strength test will be used to assess upper body strength.
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12 week
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6 Minute Walk Test
Time Frame: 12 weeks
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A 6 minute walk test will be used to assess the distance walked in 6 minutes of continuous walking.
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12 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen M Cornish, Ph.D., University of Manitoba
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2015:020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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