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Completed

NCT Number: NCT02617511

Omega-3 Supplementation and Resistance Training

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).

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Key information

Age range

65 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Applied Research Centre, Faculty of Kinesiology, University of Manitoba

Winnipeg, Manitoba, R3T2N2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3 supplementation

Dietary Supplement

Other names: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)

Placebo

Dietary Supplement

Other names: flax seed oil, evening primrose oile, canola oil, black currant oil, pumpkin seed oil

Primary outcomes

  1. 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

Secondary outcomes

  1. Interleukin-6

    Time frame: 12 weeks

    Interleukin-6 will be used to assess changes in inflammatory status.

  2. Lean Tissue Mass

    Time frame: 12 weeks

    Dual energy x-ray absorptiometry will be used to assess changes in lean tissue mass.

  3. Leg Press Strength

    Time frame: 12 weeks

    A one-repetition maximum leg press strength test will be used to assess lower body strength.

  4. Timed up and go Test

    Time frame: 12 weeks

    Mobility and balance will be assessed using a 3 meter timed up and go test.

  5. Bone Mineral Content

    Time frame: 12 weeks

    Dual energy x-ray absorptiometry will be used to assess changes in bone mass.

  6. Chest Press Strength

    Time frame: 12 week

    A one-repetition maximum chest press strength test will be used to assess upper body strength.

  7. 6 Minute Walk Test

    Time frame: 12 weeks

    A 6 minute walk test will be used to assess the distance walked in 6 minutes of continuous walking.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Manitoba Medical Service Foundation

Registry information

Official study title

Omega-3 Fatty Acid Supplementation and Resistance Training on Inflammation and Body Composition in Older Men

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 1, 2015
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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