Trial Outcomes & Findings for IgG-mediated Food Test for Weight Loss (NCT NCT01592071)
NCT ID: NCT01592071
Last Updated: 2014-03-31
Results Overview
Measure of body composition: weight (kg).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
30, 60 and 90 days from baseline
Results posted on
2014-03-31
Participant Flow
Recruitment between 2008 and 2010. Blood draws and discussion of results of blood draws performed at UM Clinical Research Building
Participant milestones
| Measure |
Non-reactive Foods
Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
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|---|---|
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Overall Study
STARTED
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120
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Overall Study
COMPLETED
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120
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IgG-mediated Food Test for Weight Loss
Baseline characteristics by cohort
| Measure |
Non-reactive Foods
n=120 Participants
Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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116 Participants
n=5 Participants
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Age, Categorical
>=65 years
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4 Participants
n=5 Participants
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Age, Continuous
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45.5 years
STANDARD_DEVIATION 12.2 • n=5 Participants
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Sex: Female, Male
Female
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101 Participants
n=5 Participants
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Sex: Female, Male
Male
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19 Participants
n=5 Participants
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Region of Enrollment
United States
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120 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 30, 60 and 90 days from baselineMeasure of body composition: weight (kg).
Outcome measures
| Measure |
Non-reactive Foods
n=120 Participants
Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
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|---|---|
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Weight (kg)
Weight (Baseline)
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80 kilograms
Standard Deviation 17.2 • Interval 2.1 to 5.2
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Weight (kg)
Weight (30 days)
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76.6 kilograms
Standard Deviation 15.8 • Interval 2.6 to 7.5
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Weight (kg)
Weight (60 days)
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74.7 kilograms
Standard Deviation 16 • Interval 1.7 to 9.4
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Weight (kg)
Weight (90 days)
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75 kilograms
Standard Deviation 17.7
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PRIMARY outcome
Timeframe: 30, 60 and 90 days from baselineMeasure of body composition: height and weight to assess BMI.
Outcome measures
| Measure |
Non-reactive Foods
n=120 Participants
Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
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|---|---|
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Body Mass Index
BMI (Baseline)
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29.0 kg/m^2
Standard Deviation 5.5 • Interval 0.38 to 0.93
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Body Mass Index
BMI (30 days)
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27.7 kg/m^2
Standard Deviation 5.6 • Interval 0.57 to 1.37
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Body Mass Index
BMI (60 days)
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27.4 kg/m^2
Standard Deviation 5.6 • Interval 0.46 to 1.67
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Body Mass Index
BMI (90 days)
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27.2 kg/m^2
Standard Deviation 5.6
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PRIMARY outcome
Timeframe: 30, 60 and 90 days from baselineMeasure of body composition: waist circumference (cm).
Outcome measures
| Measure |
Non-reactive Foods
n=120 Participants
Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
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|---|---|
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Waist Circumference
Waist Circumference (Baseline)
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91.7 centimeters
Standard Deviation 14.5
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Waist Circumference
Waist Circumference (30 days)
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85.9 centimeters
Standard Deviation 12.7
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Waist Circumference
Waist Circumference (60 days)
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85.1 centimeters
Standard Deviation 11.7
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Waist Circumference
Waist Circumference (90 days)
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84.3 centimeters
Standard Deviation 12.4
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PRIMARY outcome
Timeframe: 30, 60 or 90 days from baselineMeasure of body composition: hip circumference (cm).
Outcome measures
| Measure |
Non-reactive Foods
n=120 Participants
Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
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|---|---|
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Hip Circumference
Hip Circumference (Baseline)
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106.4 centimeters
Standard Deviation 11.4
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Hip Circumference
Hip Circumference (30 days)
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103.1 centimeters
Standard Deviation 12.4
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Hip Circumference
Hip Circumference (60 days)
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103.4 centimeters
Standard Deviation 13.5
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Hip Circumference
Hip Circumference (90 days)
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102.9 centimeters
Standard Deviation 11.2
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PRIMARY outcome
Timeframe: 30, 60 or 90 days from baselineMeasure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR).
Outcome measures
| Measure |
Non-reactive Foods
n=120 Participants
Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
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|---|---|
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Waist-Hip Ratio (WHR)
Waist-Hip Ratio (Baseline)
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0.86 ratio
Standard Deviation 0.11 • Interval 0.1 to 2.57
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Waist-Hip Ratio (WHR)
Waist-Hip Ratio (30 days)
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0.84 ratio
Standard Deviation 0.12 • Interval 0.78 to 3.36
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Waist-Hip Ratio (WHR)
Waist-Hip Ratio (60 days)
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0.83 ratio
Standard Deviation 0.09 • Interval 0.56 to 3.15
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Waist-Hip Ratio (WHR)
Waist-Hip Ratio (90 days)
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0.82 ratio
Standard Deviation 0.08 • Interval 1.38 to 3.33
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SECONDARY outcome
Timeframe: 30, 60 and 90 days from baselineSystolic and diastolic blood pressure measured.
Outcome measures
| Measure |
Non-reactive Foods
n=120 Participants
Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
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Blood Pressure
Systolic BP (Baseline)
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123.2 mm Hg
Standard Deviation 17.2
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Blood Pressure
Systolic BP (30 days)
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119.0 mm Hg
Standard Deviation 12.7
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Blood Pressure
Systolic BP (60 days)
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119.0 mm Hg
Standard Deviation 15.1
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Blood Pressure
Systolic BP (90 days)
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115.7 mm Hg
Standard Deviation 13.7
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Blood Pressure
Diastolic BP (Baseline)
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79.0 mm Hg
Standard Deviation 12.1
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Blood Pressure
Diastolic BP (30 days)
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75.9 mm Hg
Standard Deviation 9.1
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Blood Pressure
Diastolic BP (60 days)
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75.0 mm Hg
Standard Deviation 9.6
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Blood Pressure
Diastolic BP (90 days)
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74.0 mm Hg
Standard Deviation 7.3
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SECONDARY outcome
Timeframe: 30, 60 and 90 days from baselineHeart rate measured.
Outcome measures
| Measure |
Non-reactive Foods
n=120 Participants
Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
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Heart Rate
Heart Rate (Baseline)
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73.6 bpm
Standard Deviation 10.7
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Heart Rate
Heart Rate (30 days)
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72.1 bpm
Standard Deviation 9.9
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Heart Rate
Heart Rate (60 days)
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73.3 bpm
Standard Deviation 8.9
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Heart Rate
Heart Rate (90 days)
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72.5 bpm
Standard Deviation 8.4
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SECONDARY outcome
Timeframe: 30, 60 or 90 days from baselineQuality of life categories measured with the SF-36 Health Survey. The SF-36 Health Survey provides psychometrically-based physical and mental health summary measures and a preference-based health utility index.The SF-36 provides a t-score for each scale or domain ranging from 0-100 with higher scores representing better perceived quality of life.
Outcome measures
| Measure |
Non-reactive Foods
n=120 Participants
Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
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Quality of Life
Physical Role Functioning (60 days)
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88.3 Scores on a scale
Standard Deviation 14.1 • Interval -20.9 to -6.2
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Quality of Life
Physical Role Functioning (90 days)
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95.6 Scores on a scale
Standard Deviation 6.1 • Interval -18.1 to -2.5
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Quality of Life
Emotional Role Functioning (Baseline)
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85.9 Scores on a scale
Standard Deviation 19.2 • Interval -16.2 to -1.2
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Quality of Life
Mental Health (90 days)
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86.5 Scores on a scale
Standard Deviation 10.1
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Quality of Life
Vitality (60 days)
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68.0 Scores on a scale
Standard Deviation 13.7
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Quality of Life
Vitality (90 days)
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70.3 Scores on a scale
Standard Deviation 14.7
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Quality of Life
Bodily Pain (Baseline)
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67.3 Scores on a scale
Standard Deviation 22.3
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Quality of Life
Bodily Pain (30 days)
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78.4 Scores on a scale
Standard Deviation 14.3
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Quality of Life
Bodily Pain (60 days)
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79.4 Scores on a scale
Standard Deviation 9.6
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Quality of Life
Physical Functioning (Baseline)
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86.5 Scores on a scale
Standard Deviation 17.9 • Interval -10.8 to -0.23
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Quality of Life
Physical Functioning (30 days)
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91.8 Scores on a scale
Standard Deviation 11.5 • Interval -13.0 to -3.8
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Quality of Life
Physical Functioning (60 days)
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91.7 Scores on a scale
Standard Deviation 9.9 • Interval -17.1 to -5.9
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Quality of Life
Physical Functioning (90 days)
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93.8 Scores on a scale
Standard Deviation 7.0 • Interval -14.3 to -2.8
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Quality of Life
Physical Role Functioning (Baseline)
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83.9 Scores on a scale
Standard Deviation 21.4 • Interval -14.6 to -1.0
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Quality of Life
Physical Role Functioning (30 days)
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91.6 Scores on a scale
Standard Deviation 16.5 • Interval -12.7 to -3.6
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Quality of Life
Emotional Role Functioning (30 days)
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91.7 Scores on a scale
Standard Deviation 16.2 • Interval -22.3 to -5.5
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Quality of Life
Emotional Role Functioning (60 days)
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95.5 Scores on a scale
Standard Deviation 9.5 • Interval -18.3 to -3.4
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Quality of Life
Emotional Role Functioning (90 days)
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93.3 Scores on a scale
Standard Deviation 9.6 • Interval -19.2 to -4.7
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Quality of Life
Mental Health (Baseline)
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75.6 Scores on a scale
Standard Deviation 15.9 • Interval -22.0 to -5.4
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Quality of Life
Mental Health (30 days)
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83.0 Scores on a scale
Standard Deviation 15.1 • Interval -14.0 to -3.9
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Quality of Life
Mental Health (60 days)
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81.7 Scores on a scale
Standard Deviation 12.7 • Interval -15.7 to -2.5
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Quality of Life
Social Functioning (Baseline)
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80.1 Scores on a scale
Standard Deviation 22.8
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Quality of Life
Social Functioning (30 days)
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87.5 Scores on a scale
Standard Deviation 20.3
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Quality of Life
Social Functioning (60 days)
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88.5 Scores on a scale
Standard Deviation 14.2
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Quality of Life
Social Functioning (90 days)
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94.4 Scores on a scale
Standard Deviation 10.3
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Quality of Life
Vitality (Baseline)
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57.7 Scores on a scale
Standard Deviation 17.8
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Quality of Life
Vitality (30 days)
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69.9 Scores on a scale
Standard Deviation 16.2
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Quality of Life
Bodily Pain (90 days)
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78.5 Scores on a scale
Standard Deviation 13.6
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Quality of Life
General Health (Baseline)
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70.9 Scores on a scale
Standard Deviation 19.6
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Quality of Life
General Health (30 days)
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82.4 Scores on a scale
Standard Deviation 13.8
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Quality of Life
General Health (60 days)
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79.3 Scores on a scale
Standard Deviation 13.4
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Quality of Life
General Health (90 days)
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81.1 Scores on a scale
Standard Deviation 11.0
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Adverse Events
Non-reactive Foods
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place