Omega-3 Supplementation and Resistance Training

NCT02617511 | Completed Results

• 1 other identifier: E2015:020
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Sarcopenia; Dynapenia; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Interleukin-6

  12 weeks

• Lean Tissue Mass

  12 weeks

• Leg Press Strength

  12 weeks

• Timed up and go Test

  12 weeks

• Bone Mineral Content

  12 weeks

Study Arms (2)

Omega-3 Supplementation

EXPERIMENTAL

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.

Dietary Supplement: Omega-3 Supplementation

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Omega-3 Supplementation DIETARY_SUPPLEMENT

Also known as: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)

Omega-3 Supplementation

Placebo DIETARY_SUPPLEMENT

Also known as: flax seed oil, evening primrose oile, canola oil, black currant oil, pumpkin seed oil

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Medical Service Foundation: collaborator

Study Sites (1)

Applied Research Centre, Faculty of Kinesiology, University of Manitoba

Winnipeg, Manitoba, R3T2N2, Canada

Location

MeSH Terms

Conditions

Sarcopenia; Inflammation

Interventions

Eicosapentaenoic Acid; Docosahexaenoic Acids; Linseed Oil; Rapeseed Oil; black currant oil

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Stephen Cornish
• Organization: University of Manitoba

Stephen.Cornish@umanitoba.ca

204-474-9981

Study Officials

• Stephen M Cornish, Ph.D.

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 1, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: September 13, 2023
• Results First Posted: September 13, 2023

Record last verified: 2015-11

Locations

CA (1)