Clinical trial NCT02617511: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Dynapenia
Inflammation
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Medical Service Foundation
First posted: 2015-12-01
Enrollment: 24
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. equal to or greater than 65 years of age,
2. male,
3. they will not participate in a structured exercise program any more than 2-times per week.

Exclusion Criteria:

1. consumption of anti-inflammatory medication (which would confound the results in terms of the effects that the exercise and nutritional intervention is accomplishing),
2. diagnosis with an inflammatory disease (such as inflammatory bowel disease or rheumatoid arthritis) as this is not the participant population we want to evaluate,
3. 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),
4. 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,
5. has a mental or cognitive disability (such as dementia), and
6. has a physical disability that would limit them from participating in a structured resistance training program.

Primary outcomes:
measure: Tumor Necrosis Factor-alpha
timeFrame: 12 weeks
Secondary outcomes:
measure: Interleukin-6
timeFrame: 12 weeks
measure: Lean Tissue Mass
timeFrame: 12 weeks
measure: Leg Press Strength
timeFrame: 12 weeks
measure: Timed up and go Test
timeFrame: 12 weeks
measure: Bone Mineral Content
timeFrame: 12 weeks
measure: Chest Press Strength
timeFrame: 12 week
measure: 6 Minute Walk Test
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Applied Research Centre, Faculty of Kinesiology, University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Stephen M Cornish, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: