NCT00899353 · OUTCOME
Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- 10^6 NFkB Luminescence units/µg protein
- Interval / dispersion
- Standard Error
- Time frame
- baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement)
What was measured
Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer's protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.
Analysis population: NFkB activation of all patients diagnosed with early stage CLL at baseline and following omega 3 consumption. Patients are further separated into high (\> median, n=7) and low initial baseline (\< median, n=6) NFkB. Patients included must have had one baseline and at least one period of omega 3 consumption. Not all patients completed all periods
Groups in this outcome
Baseline Nuclear Factor Kappa B Activation
Baseline nuclear factor Kappa B (NFkB) activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia.
Nuclear Factor Kappa B Activation Following 3 Capsules Per Day
Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 3 capsules per day (2.4 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
Nuclear Factor Kappa B Activation Following 6 Capsules Per Day
Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 6 capsules per day (4.8 g of omega 3 per day).Each 1250mg capsule provided 800mg of omega 3.
Nuclear Factor Kappa B Activation Following 9 Capsules Per Day
Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 9 capsules per day (7.2 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
Nuclear Factor Kappa B Activation Post Supplement
Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following discontinued consumption of omega 3.
| Group | Source count |
|---|---|
| Baseline Nuclear Factor Kappa B Activation | 15 |
| Nuclear Factor Kappa B Activation Following 3 Capsules Per Day | 12 |
| Nuclear Factor Kappa B Activation Following 6 Capsules Per Day | 12 |
| Nuclear Factor Kappa B Activation Following 9 Capsules Per Day | 10 |
| Nuclear Factor Kappa B Activation Post Supplement | 8 |
Reported measurements
Total Population
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Baseline Nuclear Factor Kappa B Activation | 7.2 | 2.25 | 0.945 | 231 | Not reported |
| Nuclear Factor Kappa B Activation Following 3 Capsules Per Day | 4.1 | 1.53 | Not reported | Not reported | Not reported |
| Nuclear Factor Kappa B Activation Following 6 Capsules Per Day | 4.2 | 1.15 | Not reported | Not reported | Not reported |
| Nuclear Factor Kappa B Activation Following 9 Capsules Per Day | 0.7 | 0.94 | Not reported | Not reported | Not reported |
| Nuclear Factor Kappa B Activation Post Supplement | 1.5 | 0.86 | Not reported | Not reported | Not reported |
Higher Initial Expressers
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Baseline Nuclear Factor Kappa B Activation | 12.8 | 2.77 | Not reported | Not reported | Not reported |
| Nuclear Factor Kappa B Activation Following 3 Capsules Per Day | 7.4 | 2.41 | Not reported | Not reported | Not reported |
| Nuclear Factor Kappa B Activation Following 6 Capsules Per Day | 6.4 | 1.42 | Not reported | Not reported | Not reported |
| Nuclear Factor Kappa B Activation Following 9 Capsules Per Day | 0.8 | 0.20 | Not reported | Not reported | Not reported |
| Nuclear Factor Kappa B Activation Post Supplement | 1.6 | 1.44 | Not reported | Not reported | Not reported |
Lower Initial Expressers
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Baseline Nuclear Factor Kappa B Activation | 0.8 | 0.27 | Not reported | Not reported | Not reported |
| Nuclear Factor Kappa B Activation Following 3 Capsules Per Day | 0.9 | 0.37 | Not reported | Not reported | Not reported |
| Nuclear Factor Kappa B Activation Following 6 Capsules Per Day | 1.5 | 0.80 | Not reported | Not reported | Not reported |
| Nuclear Factor Kappa B Activation Following 9 Capsules Per Day | 0.6 | 0.11 | Not reported | Not reported | Not reported |
| Nuclear Factor Kappa B Activation Post Supplement | 1.3 | 1.16 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -5.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.2
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.7
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on global response.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.78
- param Type
- Mean Difference (Final Values)
- param Value
- 3.1
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -4.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.7
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.5
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on global response.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.75
- param Type
- Mean Difference (Final Values)
- param Value
- 3.0
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -0.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.7
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.3
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on global response.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.08
- param Type
- Mean Difference (Final Values)
- param Value
- 6.6
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -1.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.2
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.4
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on global response.
- group Ids
- OG000
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.17
- param Type
- Mean Difference (Final Values)
- param Value
- 5.8
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -6.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.2
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 3.7
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on High Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.61
- param Type
- Mean Difference (Final Values)
- param Value
- 5.3
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -4.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 16.8
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 3.1
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on High Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.32
- param Type
- Mean Difference (Final Values)
- param Value
- 6.3
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- 1.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 22.3
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.8
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on High Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.03
- param Type
- Mean Difference (Final Values)
- param Value
- 12.0
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- 0.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.8
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 3.1
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on High Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.04
- param Type
- Mean Difference (Final Values)
- param Value
- 11.1
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -1.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.2
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.4
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on Low Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 1.00
- param Type
- Mean Difference (Final Values)
- param Value
- -0.1
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -3.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.3
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.7
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on Low Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.88
- param Type
- Mean Difference (Final Values)
- param Value
- -0.6
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -0.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.0
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.3
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on Low Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.98
- param Type
- Mean Difference (Final Values)
- param Value
- 0.1
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -6.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.3
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.2
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on Low Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.98
- param Type
- Mean Difference (Final Values)
- param Value
- -0.6
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- -5.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.2
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.7
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on global response.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.78
- param Type
- Mean Difference (Final Values)
- param Value
- 3.1
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -4.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.7
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.5
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on global response.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.75
- param Type
- Mean Difference (Final Values)
- param Value
- 3.0
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -0.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.7
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.3
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on global response.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.08
- param Type
- Mean Difference (Final Values)
- param Value
- 6.6
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -1.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.2
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.4
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on global response.
- group Ids
- OG000
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.17
- param Type
- Mean Difference (Final Values)
- param Value
- 5.8
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -6.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.2
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 3.7
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on High Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.61
- param Type
- Mean Difference (Final Values)
- param Value
- 5.3
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -4.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 16.8
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 3.1
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on High Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.32
- param Type
- Mean Difference (Final Values)
- param Value
- 6.3
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- 1.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 22.3
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 2.8
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on High Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.03
- param Type
- Mean Difference (Final Values)
- param Value
- 12.0
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- 0.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.8
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 3.1
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on High Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.04
- param Type
- Mean Difference (Final Values)
- param Value
- 11.1
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -1.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.2
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.4
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on Low Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 1.00
- param Type
- Mean Difference (Final Values)
- param Value
- -0.1
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -3.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.3
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.7
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on Low Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.88
- param Type
- Mean Difference (Final Values)
- param Value
- -0.6
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -0.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.0
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.3
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on Low Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.98
- param Type
- Mean Difference (Final Values)
- param Value
- 0.1
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- ci Lower Limit
- -6.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.3
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.2
- group Description
- Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05. Analysis based on Low Initial NFkB Activation Expressers.
- group Ids
- OG000
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.98
- param Type
- Mean Difference (Final Values)
- param Value
- -0.6
- statistical Comment
- Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.
- statistical Method
- ANOVA
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.945
- spread
- 2.25
- upper Limit
- 231
- value
- 7.2
- group Id
- OG001
- spread
- 1.53
- value
- 4.1
- group Id
- OG002
- spread
- 1.15
- value
- 4.2
- group Id
- OG003
- spread
- 0.94
- value
- 0.7
- group Id
- OG004
- spread
- 0.86
- value
- 1.5
- title
- Total Population
- categories
- measurements
- group Id
- OG000
- spread
- 2.77
- value
- 12.8
- group Id
- OG001
- spread
- 2.41
- value
- 7.4
- group Id
- OG002
- spread
- 1.42
- value
- 6.4
- group Id
- OG003
- spread
- 0.20
- value
- 0.8
- group Id
- OG004
- spread
- 1.44
- value
- 1.6
- title
- Higher Initial Expressers
- categories
- measurements
- group Id
- OG000
- spread
- 0.27
- value
- 0.8
- group Id
- OG001
- spread
- 0.37
- value
- 0.9
- group Id
- OG002
- spread
- 0.80
- value
- 1.5
- group Id
- OG003
- spread
- 0.11
- value
- 0.6
- group Id
- OG004
- spread
- 1.16
- value
- 1.3
- title
- Lower Initial Expressers
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 8
- units
- Participants
- description
- Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer's protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.
- dispersion Type
- Standard Error
- groups
- description
- Baseline nuclear factor Kappa B (NFkB) activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia.
- id
- OG000
- title
- Baseline Nuclear Factor Kappa B Activation
- description
- Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 3 capsules per day (2.4 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
- id
- OG001
- title
- Nuclear Factor Kappa B Activation Following 3 Capsules Per Day
- description
- Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 6 capsules per day (4.8 g of omega 3 per day).Each 1250mg capsule provided 800mg of omega 3.
- id
- OG002
- title
- Nuclear Factor Kappa B Activation Following 6 Capsules Per Day
- description
- Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 9 capsules per day (7.2 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
- id
- OG003
- title
- Nuclear Factor Kappa B Activation Following 9 Capsules Per Day
- description
- Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following discontinued consumption of omega 3.
- id
- OG004
- title
- Nuclear Factor Kappa B Activation Post Supplement
- param Type
- MEAN
- population Description
- NFkB activation of all patients diagnosed with early stage CLL at baseline and following omega 3 consumption. Patients are further separated into high (\> median, n=7) and low initial baseline (\< median, n=6) NFkB. Patients included must have had one baseline and at least one period of omega 3 consumption. Not all patients completed all periods
- reporting Status
- POSTED
- time Frame
- baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement)
- title
- Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.
- type
- PRIMARY
- unit Of Measure
- 10^6 NFkB Luminescence units/µg protein
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle