Trial Outcomes & Findings for The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers (NCT NCT00805870)

Results Overview

Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

6 days

Results posted on

2012-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	Fish Oil Lovaza, 3 grams/day for 65 days	Control Wheat Germ Oil, 3 grams/day for 65 days
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fish Oil n=10 Participants Lovaza, 3 grams/day for 65 days	Control n=10 Participants Wheat Germ Oil, 3 grams/day for 65 days	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	21.9 years STANDARD_DEVIATION 1.7 • n=5 Participants	23.4 years STANDARD_DEVIATION 2.3 • n=7 Participants	22.7 years STANDARD_DEVIATION 2.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 days

Population: Number of subjects that completed the protocol. Analysis was per protocol.

Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise.

Outcome measures

Outcome measures
Measure	Fish Oil n=10 Participants 3 grams/day of fish oil for 65 days	Control n=10 Participants 3.45 grams/day of wheat germ oil for 65 days
Quadriceps Muscle Strength	151 lbs Standard Deviation 6	160 lbs Standard Deviation 8

PRIMARY outcome

Timeframe: 6 days

Population: Number of subjects that completed the protocol. Analysis was per protocol.

The required amount of force applied to the quadriceps to elicit pain or discomfort.

Outcome measures

Outcome measures
Measure	Fish Oil n=10 Participants 3 grams/day of fish oil for 65 days	Control n=10 Participants 3.45 grams/day of wheat germ oil for 65 days
Muscle Soreness of the Quadriceps Using an Algometer Strain Gauge	14.62 lbs Standard Deviation 0.47	16.46 lbs Standard Deviation 0.37

PRIMARY outcome

Timeframe: 6 days

Population: Number of subjects that completed the protocol. Analysis was per protocol.

Creatine kinase activity is an indirect indicator of muscle damage.

Outcome measures

Outcome measures
Measure	Fish Oil n=10 Participants 3 grams/day of fish oil for 65 days	Control n=10 Participants 3.45 grams/day of wheat germ oil for 65 days
Creatine Kinase Activity Measured in Blood	110.20 IU/L Standard Deviation 11.81	167.21 IU/L Standard Deviation 15.18

PRIMARY outcome

Timeframe: 6 days

Population: Number of subjects that completed the protocol. Analysis was per protocol

Interleukin-6 is an indirect indicator of muscle inflammation.

Outcome measures

Outcome measures
Measure	Fish Oil n=10 Participants 3 grams/day of fish oil for 65 days	Control n=10 Participants 3.45 grams/day of wheat germ oil for 65 days
Interleukin-6 Measured in Blood	0.23 pg/mL Standard Deviation 0.07	0.21 pg/mL Standard Deviation 0.05

Adverse Events

Fish Oil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christopher C. Cheatham

Western Michigan University

Phone: 269-387-2542

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place