Trial Outcomes & Findings for Omega-3 Supplementation and Resistance Training (NCT NCT02617511)

NCT ID: NCT02617511

Last Updated: 2023-09-13

Results Overview

The cytokine tumor necrosis factor-alpha will be used as the primary outcome to assess change in inflammatory status over the 12 week intervention

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2023-09-13

Participant Flow

Participant milestones

Measure	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. Omega-3 Supplementation	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. Placebo
Overall Study STARTED	12	12
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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. Omega-3 Supplementation	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. Placebo
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Omega-3 Supplementation and Resistance Training

Baseline characteristics by cohort

Measure	Omega-3 Supplementation n=11 Participants 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. Omega-3 Supplementation	Placebo n=12 Participants 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. Placebo	Total n=23 Participants Total of all reporting groups
Age, Continuous	71.4 years STANDARD_DEVIATION 6.2 • n=5 Participants	70.9 years STANDARD_DEVIATION 5.0 • n=7 Participants	71.1 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment Canada	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants
Baseline Characteristics	175.1 Height (cm) STANDARD_DEVIATION 4.7 • n=5 Participants	176.7 Height (cm) STANDARD_DEVIATION 5.7 • n=7 Participants	175.9 Height (cm) STANDARD_DEVIATION 5.2 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Omega-3 Supplementation n=11 Participants 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. Omega-3 Supplementation	Placebo n=12 Participants 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. Placebo
Tumor Necrosis Factor-alpha Baseline	1.05 pg/mL Standard Deviation 0.49	0.93 pg/mL Standard Deviation 0.54
Tumor Necrosis Factor-alpha 12 weeks post	1.04 pg/mL Standard Deviation 0.41	1.18 pg/mL Standard Deviation 0.59

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Omega-3 Supplementation n=11 Participants 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. Omega-3 Supplementation	Placebo n=12 Participants 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. Placebo
Interleukin-6 Baseline	2.01 pg/mL Standard Deviation 1.49	1.84 pg/mL Standard Deviation 0.93
Interleukin-6 12 weeks post	2.1 pg/mL Standard Deviation 1.49	2.19 pg/mL Standard Deviation 1.21

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Omega-3 Supplementation n=11 Participants 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. Omega-3 Supplementation	Placebo n=12 Participants 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. Placebo
Lean Tissue Mass Baseline	55.2 kilograms Standard Deviation 6.3	55.8 kilograms Standard Deviation 6.1
Lean Tissue Mass 12 weeks post	55.7 kilograms Standard Deviation 5.9	56.5 kilograms Standard Deviation 5.6

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Omega-3 Supplementation n=11 Participants 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. Omega-3 Supplementation	Placebo n=12 Participants 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. Placebo
Leg Press Strength Baseline	114.5 kilograms Standard Deviation 38.4	105.7 kilograms Standard Deviation 27.8
Leg Press Strength 12 weeks post	158.7 kilograms Standard Deviation 50	142.0 kilograms Standard Deviation 31.2

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Omega-3 Supplementation n=11 Participants 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. Omega-3 Supplementation	Placebo n=12 Participants 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. Placebo
Timed up and go Test Baseline	6.35 seconds Standard Deviation 1.06	5.91 seconds Standard Deviation 0.58
Timed up and go Test 12 weeks post	5.83 seconds Standard Deviation 1.11	5.62 seconds Standard Deviation 0.44

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Omega-3 Supplementation n=11 Participants 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. Omega-3 Supplementation	Placebo n=12 Participants 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. Placebo
Bone Mineral Content Baseline	3.18 kilograms Standard Deviation 0.31	3.26 kilograms Standard Deviation 0.15
Bone Mineral Content 12 week post	3.19 kilograms Standard Deviation 0.31	3.26 kilograms Standard Deviation 0.16

SECONDARY outcome

Timeframe: 12 week

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

Outcome measures

Measure	Omega-3 Supplementation n=11 Participants 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. Omega-3 Supplementation	Placebo n=12 Participants 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. Placebo
Chest Press Strength Baseline	51.4 kilograms Standard Deviation 19.6	49.6 kilograms Standard Deviation 14.3
Chest Press Strength 12 weeks post	67.2 kilograms Standard Deviation 25.1	65.0 kilograms Standard Deviation 13.9

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Omega-3 Supplementation n=11 Participants 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. Omega-3 Supplementation	Placebo n=12 Participants 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. Placebo
6 Minute Walk Test Baseline	604.8 meters Standard Deviation 71.1	622.5 meters Standard Deviation 43.6
6 Minute Walk Test 12 weeks post	636.7 meters Standard Deviation 89.8	646.4 meters Standard Deviation 64.6

Adverse Events

Omega-3 Supplementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Omega-3 Supplementation n=11 participants at risk 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. Omega-3 Supplementation	Placebo n=12 participants at risk 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. Placebo
Gastrointestinal disorders Diarrhea	0.00% 0/11	8.3% 1/12 • Number of events 1

Additional Information

Dr. Stephen Cornish

University of Manitoba

Phone: 204-474-9981

Email: Stephen.Cornish@umanitoba.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place