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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.

Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM) · Source last updated 2013-12-12

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Baseline Nuclear Factor Kappa B Activation15
Nuclear Factor Kappa B Activation Following 3 Capsules Per Day12
Nuclear Factor Kappa B Activation Following 6 Capsules Per Day12
Nuclear Factor Kappa B Activation Following 9 Capsules Per Day10
Nuclear Factor Kappa B Activation Post Supplement8

Reported measurements

Total Population
Values in 10^6 NFkB Luminescence units/µg protein · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Baseline Nuclear Factor Kappa B Activation7.22.250.945231Not reported
Nuclear Factor Kappa B Activation Following 3 Capsules Per Day4.11.53Not reportedNot reportedNot reported
Nuclear Factor Kappa B Activation Following 6 Capsules Per Day4.21.15Not reportedNot reportedNot reported
Nuclear Factor Kappa B Activation Following 9 Capsules Per Day0.70.94Not reportedNot reportedNot reported
Nuclear Factor Kappa B Activation Post Supplement1.50.86Not reportedNot reportedNot reported
Higher Initial Expressers
Values in 10^6 NFkB Luminescence units/µg protein · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Baseline Nuclear Factor Kappa B Activation12.82.77Not reportedNot reportedNot reported
Nuclear Factor Kappa B Activation Following 3 Capsules Per Day7.42.41Not reportedNot reportedNot reported
Nuclear Factor Kappa B Activation Following 6 Capsules Per Day6.41.42Not reportedNot reportedNot reported
Nuclear Factor Kappa B Activation Following 9 Capsules Per Day0.80.20Not reportedNot reportedNot reported
Nuclear Factor Kappa B Activation Post Supplement1.61.44Not reportedNot reportedNot reported
Lower Initial Expressers
Values in 10^6 NFkB Luminescence units/µg protein · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Baseline Nuclear Factor Kappa B Activation0.80.27Not reportedNot reportedNot reported
Nuclear Factor Kappa B Activation Following 3 Capsules Per Day0.90.37Not reportedNot reportedNot reported
Nuclear Factor Kappa B Activation Following 6 Capsules Per Day1.50.80Not reportedNot reportedNot reported
Nuclear Factor Kappa B Activation Following 9 Capsules Per Day0.60.11Not reportedNot reportedNot reported
Nuclear Factor Kappa B Activation Post Supplement1.31.16Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. 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
    1. OG000
    2. 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
  2. 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
    1. OG000
    2. 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
  3. 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
    1. OG000
    2. 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
  4. 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
    1. OG000
    2. 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
  5. 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
    1. OG000
    2. 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
  6. 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
    1. OG000
    2. 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
  7. 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
    1. OG000
    2. 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
  8. 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
    1. OG000
    2. 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
  9. 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
    1. OG000
    2. 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
  10. 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
    1. OG000
    2. 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
  11. 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
    1. OG000
    2. 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
  12. 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
    1. OG000
    2. 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
  1. 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
    1. OG000
    2. 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
  2. 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
    1. OG000
    2. 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
  3. 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
    1. OG000
    2. 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
  4. 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
    1. OG000
    2. 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
  5. 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
    1. OG000
    2. 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
  6. 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
    1. OG000
    2. 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
  7. 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
    1. OG000
    2. 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
  8. 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
    1. OG000
    2. 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
  9. 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
    1. OG000
    2. 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
  10. 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
    1. OG000
    2. 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
  11. 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
    1. OG000
    2. 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
  12. 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
    1. OG000
    2. 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
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.945
        spread
        2.25
        upper Limit
        231
        value
        7.2
      2. group Id
        OG001
        spread
        1.53
        value
        4.1
      3. group Id
        OG002
        spread
        1.15
        value
        4.2
      4. group Id
        OG003
        spread
        0.94
        value
        0.7
      5. group Id
        OG004
        spread
        0.86
        value
        1.5
    title
    Total Population
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.77
        value
        12.8
      2. group Id
        OG001
        spread
        2.41
        value
        7.4
      3. group Id
        OG002
        spread
        1.42
        value
        6.4
      4. group Id
        OG003
        spread
        0.20
        value
        0.8
      5. group Id
        OG004
        spread
        1.44
        value
        1.6
    title
    Higher Initial Expressers
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.27
        value
        0.8
      2. group Id
        OG001
        spread
        0.37
        value
        0.9
      3. group Id
        OG002
        spread
        0.80
        value
        1.5
      4. group Id
        OG003
        spread
        0.11
        value
        0.6
      5. group Id
        OG004
        spread
        1.16
        value
        1.3
    title
    Lower Initial Expressers
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      10
    5. 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
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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

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