Omega-3 Supplementation and Resistance Training
Primary Purpose
Sarcopenia, Dynapenia, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Omega-3 Supplementation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
Eligibility Criteria
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.
Sites / Locations
- Applied Research Centre, Faculty of Kinesiology, University of Manitoba
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omega-3 Supplementation
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Tumor Necrosis Factor-alpha
The cytokine tumor necrosis factor-alpha will be used as the primary outcome to assess change in inflammatory status over the 12 week intervention
Secondary Outcome Measures
Interleukin-6
Interleukin-6 will be used to assess changes in inflammatory status.
Lean Tissue Mass
Dual energy x-ray absorptiometry will be used to assess changes in lean tissue mass.
Leg Press Strength
A one-repetition maximum leg press strength test will be used to assess lower body strength.
Timed up and go Test
Mobility and balance will be assessed using a 3 meter timed up and go test.
Bone Mineral Content
Dual energy x-ray absorptiometry will be used to assess changes in bone mass.
Chest Press Strength
A one-repetition maximum chest press strength test will be used to assess upper body strength.
6 Minute Walk Test
A 6 minute walk test will be used to assess the distance walked in 6 minutes of continuous walking.
Full Information
NCT ID
NCT02617511
First Posted
November 23, 2015
Last Updated
November 1, 2022
Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02617511
Brief Title
Omega-3 Supplementation and Resistance Training
Official Title
Omega-3 Fatty Acid Supplementation and Resistance Training on Inflammation and Body Composition in Older Men
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this project is to evaluate whether omega-3 fatty acid supplementation (combined eicosapentaenoic acid and docosahexaenoic acid [EPA/DHA] supplement) augments the effects of a 12-week resistance training program in older men. Outcome variables include inflammatory biomarkers in the systemic circulation, body composition and performance measures. The specific inflammatory markers in the blood include: C-reactive protein, tumor necrosis factor-α, interleukin-1β, and interleukin-6. Remaining parameters include: body composition (as assessed by dual energy x-ray absorptiometry), muscle strength (as assessed by chest press and leg press one-repetition maximum strength tests), and functional ability (as assessed by timed up and go test as well as the 6-minute walking test).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Dynapenia, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega-3 Supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Supplementation
Other Intervention Name(s)
eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
flax seed oil, evening primrose oile, canola oil, black currant oil, pumpkin seed oil
Primary Outcome Measure Information:
Title
Tumor Necrosis Factor-alpha
Description
The cytokine tumor necrosis factor-alpha will be used as the primary outcome to assess change in inflammatory status over the 12 week intervention
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Interleukin-6
Description
Interleukin-6 will be used to assess changes in inflammatory status.
Time Frame
12 weeks
Title
Lean Tissue Mass
Description
Dual energy x-ray absorptiometry will be used to assess changes in lean tissue mass.
Time Frame
12 weeks
Title
Leg Press Strength
Description
A one-repetition maximum leg press strength test will be used to assess lower body strength.
Time Frame
12 weeks
Title
Timed up and go Test
Description
Mobility and balance will be assessed using a 3 meter timed up and go test.
Time Frame
12 weeks
Title
Bone Mineral Content
Description
Dual energy x-ray absorptiometry will be used to assess changes in bone mass.
Time Frame
12 weeks
Title
Chest Press Strength
Description
A one-repetition maximum chest press strength test will be used to assess upper body strength.
Time Frame
12 week
Title
6 Minute Walk Test
Description
A 6 minute walk test will be used to assess the distance walked in 6 minutes of continuous walking.
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen M Cornish, Ph.D.
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Research Centre, Faculty of Kinesiology, University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T2N2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Omega-3 Supplementation and Resistance Training
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