Omega-3 Supplementation and Resistance Training

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617511
• Other study ID #: E2015:020
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dynapenia
• Inflammation
• Sarcopenia

Intervention

Dietary Supplement:
• Omega-3 Supplementation

• Placebo

Locations

Country	Name	City	State
Canada	Applied Research Centre, Faculty of Kinesiology, University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Manitoba Medical Service Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks
Secondary	Interleukin-6	Interleukin-6 will be used to assess changes in inflammatory status.	12 weeks
Secondary	Lean Tissue Mass	Dual energy x-ray absorptiometry will be used to assess changes in lean tissue mass.	12 weeks
Secondary	Leg Press Strength	A one-repetition maximum leg press strength test will be used to assess lower body strength.	12 weeks
Secondary	Timed up and go Test	Mobility and balance will be assessed using a 3 meter timed up and go test.	12 weeks
Secondary	Bone Mineral Content	Dual energy x-ray absorptiometry will be used to assess changes in bone mass.	12 weeks
Secondary	Chest Press Strength	A one-repetition maximum chest press strength test will be used to assess upper body strength.	12 week
Secondary	6 Minute Walk Test	A 6 minute walk test will be used to assess the distance walked in 6 minutes of continuous walking.	12 weeks