Omega-3 Supplementation and Resistance Training

November 1, 2022 updated by: University of Manitoba

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

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).

Study Overview

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

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T2N2
        • Applied Research Centre, Faculty of Kinesiology, University of Manitoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other Names:
  • eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
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.
Other Names:
  • flax seed oil, evening primrose oile, canola oil, black currant oil, pumpkin seed oil

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
12 weeks

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.
12 weeks
Leg Press Strength
Time Frame: 12 weeks
A one-repetition maximum leg press strength test will be used to assess lower body strength.
12 weeks
Lean Tissue Mass
Time Frame: 12 weeks
Dual energy x-ray absorptiometry will be used to assess changes in lean tissue mass.
12 weeks
Timed up and go Test
Time Frame: 12 weeks
Mobility and balance will be assessed using a 3 meter timed up and go test.
12 weeks
Bone Mineral Content
Time Frame: 12 weeks
Dual energy x-ray absorptiometry will be used to assess changes in bone mass.
12 weeks
Chest Press Strength
Time Frame: 12 week
A one-repetition maximum chest press strength test will be used to assess upper body strength.
12 week
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stephen M Cornish, Ph.D., University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimated)

December 1, 2015

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2015

More Information

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.

Clinical Trials on Inflammation

Clinical Trials on Placebo

3
Subscribe