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Trial record 66 of 215 for:    Inflammatory Myopathies

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

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ClinicalTrials.gov Identifier: NCT00805870
Recruitment Status : Completed
First Posted : December 10, 2008
Results First Posted : September 5, 2012
Last Update Posted : September 5, 2012
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Christopher Cheatham, Western Michigan University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Muscle Damage
Muscle Inflammation
Interventions Drug: Lovaza (omega-3-acid ethyl esters)
Drug: Wheat Germ Oil
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fish Oil Control
Hide Arm/Group Description Lovaza, 3 grams/day for 65 days Wheat Germ Oil, 3 grams/day for 65 days
Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Fish Oil Control Total
Hide Arm/Group Description Lovaza, 3 grams/day for 65 days Wheat Germ Oil, 3 grams/day for 65 days Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
21.9  (1.7) 23.4  (2.3) 22.7  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
5
  50.0%
5
  50.0%
10
  50.0%
Male
5
  50.0%
5
  50.0%
10
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Quadriceps Muscle Strength
Hide Description Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise.
Time Frame 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects that completed the protocol. Analysis was per protocol.
Arm/Group Title Fish Oil Control
Hide Arm/Group Description:
3 grams/day of fish oil for 65 days
3.45 grams/day of wheat germ oil for 65 days
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: lbs
151  (6) 160  (8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fish Oil, Control
Comments Null hypothesis is that no difference is observed in quadriceps muscle strength between the fish oil and control groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 8.271
Confidence Interval (2-Sided) 95%
-63.521 to 46.978
Parameter Dispersion
Type: Standard Error of the mean
Value: 26.298
Estimation Comments [Not Specified]
2.Primary Outcome
Title Muscle Soreness of the Quadriceps Using an Algometer Strain Gauge
Hide Description The required amount of force applied to the quadriceps to elicit pain or discomfort.
Time Frame 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects that completed the protocol. Analysis was per protocol.
Arm/Group Title Fish Oil Control
Hide Arm/Group Description:
3 grams/day of fish oil for 65 days
3.45 grams/day of wheat germ oil for 65 days
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: lbs
14.62  (0.47) 16.46  (0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fish Oil, Control
Comments Null hypothesis is that there is no difference in the amount of force applied to the quadriceps to elicit pain or discomfort between the fish oil and control groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.845
Confidence Interval (2-Sided) 95%
-4.823 to 1.132
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.417
Estimation Comments [Not Specified]
3.Primary Outcome
Title Creatine Kinase Activity Measured in Blood
Hide Description Creatine kinase activity is an indirect indicator of muscle damage.
Time Frame 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects that completed the protocol. Analysis was per protocol.
Arm/Group Title Fish Oil Control
Hide Arm/Group Description:
3 grams/day of fish oil for 65 days
3.45 grams/day of wheat germ oil for 65 days
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: IU/L
110.20  (11.81) 167.21  (15.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fish Oil, Control
Comments Null hypothesis is that there is no difference in creatine kinase activity between the fish oil and the control groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -57.015
Confidence Interval (2-Sided) 95%
-156.373 to 42.344
Parameter Dispersion
Type: Standard Error of the mean
Value: 47.093
Estimation Comments [Not Specified]
4.Primary Outcome
Title Interleukin-6 Measured in Blood
Hide Description Interleukin-6 is an indirect indicator of muscle inflammation.
Time Frame 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects that completed the protocol. Analysis was per protocol
Arm/Group Title Fish Oil Control
Hide Arm/Group Description:
3 grams/day of fish oil for 65 days
3.45 grams/day of wheat germ oil for 65 days
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: pg/mL
0.23  (0.07) 0.21  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fish Oil, Control
Comments The null hypothesis is that there is no difference in interleukin-6 concentration between the fish oil and control groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.022
Confidence Interval (2-Sided) 95%
-0.374 to 0.417
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.188
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fish Oil Control
Hide Arm/Group Description Lovaza, 3 grams/day for 65 days Wheat Germ Oil, 3 grams/day for 65 days
All-Cause Mortality
Fish Oil Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fish Oil Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fish Oil Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Christopher C. Cheatham
Organization: Western Michigan University
Phone: 269-387-2542
Responsible Party: Christopher Cheatham, Western Michigan University
ClinicalTrials.gov Identifier: NCT00805870     History of Changes
Other Study ID Numbers: 08-02-31
First Submitted: December 9, 2008
First Posted: December 10, 2008
Results First Submitted: August 11, 2011
Results First Posted: September 5, 2012
Last Update Posted: September 5, 2012