Trial Outcomes & Findings for An Investigation Into the Effects of a Wild Blueberry Powder and a Wild Blueberry Extract on Cognition in Older Adults (NCT NCT02446314)
NCT ID: NCT02446314
Last Updated: 2019-08-08
Results Overview
Participants indicate whether words presented on a monitor are from a list of 15 words previously presented auditorily (via headphones), or if they are novel foils.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
12, and 24 weeks
Results posted on
2019-08-08
Participant Flow
Participant milestones
| Measure |
Placebo
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 450mg
Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 900 mg
Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 900 mg: Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
|
Wild Blueberry Extract 100mg
Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
|
|---|---|---|---|---|
|
Zero to Twelve Weeks.
STARTED
|
30
|
30
|
31
|
31
|
|
Zero to Twelve Weeks.
COMPLETED
|
27
|
29
|
31
|
29
|
|
Zero to Twelve Weeks.
NOT COMPLETED
|
3
|
1
|
0
|
2
|
|
Thirteen to Twenty Four Weeks
STARTED
|
27
|
29
|
31
|
29
|
|
Thirteen to Twenty Four Weeks
COMPLETED
|
27
|
28
|
29
|
28
|
|
Thirteen to Twenty Four Weeks
NOT COMPLETED
|
0
|
1
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Investigation Into the Effects of a Wild Blueberry Powder and a Wild Blueberry Extract on Cognition in Older Adults
Baseline characteristics by cohort
| Measure |
Placebo
n=30 Participants
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 450mg
n=30 Participants
Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 900 mg
n=31 Participants
Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
|
Wild Blueberry Extract 100mg
n=31 Participants
Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 3.07 • n=93 Participants
|
70.5 years
STANDARD_DEVIATION 2.87 • n=4 Participants
|
70.3 years
STANDARD_DEVIATION 3.59 • n=27 Participants
|
70.2 years
STANDARD_DEVIATION 4.30 • n=483 Participants
|
70.5 years
STANDARD_DEVIATION 3.47 • n=36 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
75 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
47 Participants
n=36 Participants
|
|
Region of Enrollment
United Kingdom
|
30 participants
n=93 Participants
|
30 participants
n=4 Participants
|
31 participants
n=27 Participants
|
31 participants
n=483 Participants
|
122 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 12, and 24 weeksParticipants indicate whether words presented on a monitor are from a list of 15 words previously presented auditorily (via headphones), or if they are novel foils.
Outcome measures
| Measure |
Placebo
n=27 Participants
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 450mg
n=28 Participants
Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 900 mg
n=29 Participants
Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 900 mg: Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
|
Wild Blueberry Extract 100mg
n=28 Participants
Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
|
|---|---|---|---|---|
|
Proportion of Words Correctly Recognised.
12 Weeks
|
0.86 proportion of words correctly recognised
Standard Error 0.02
|
0.85 proportion of words correctly recognised
Standard Error 0.02
|
0.79 proportion of words correctly recognised
Standard Error 0.02
|
0.90 proportion of words correctly recognised
Standard Error 0.02
|
|
Proportion of Words Correctly Recognised.
24 Weeks
|
0.90 proportion of words correctly recognised
Standard Error 0.02
|
0.88 proportion of words correctly recognised
Standard Error 0.02
|
0.87 proportion of words correctly recognised
Standard Error 0.02
|
0.88 proportion of words correctly recognised
Standard Error 0.02
|
PRIMARY outcome
Timeframe: 12, and 24 weeksParticipants view an array of 9 white squares on a monitor which light up red in sequences of between 2 and 9. They are then required to press the correct squares in the sequence they were presented.
Outcome measures
| Measure |
Placebo
n=27 Participants
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 450mg
n=28 Participants
Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 900 mg
n=29 Participants
Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 900 mg: Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
|
Wild Blueberry Extract 100mg
n=28 Participants
Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
|
|---|---|---|---|---|
|
Total Number of Correct Sequences Recalled
24 Weeks
|
15.56 Correct number of sequences
Standard Error 0.48
|
16.348 Correct number of sequences
Standard Error 0.47
|
15.921 Correct number of sequences
Standard Error 0.46
|
16.302 Correct number of sequences
Standard Error 0.46
|
|
Total Number of Correct Sequences Recalled
12 Weeks
|
15.15 Correct number of sequences
Standard Error 0.41
|
14.27 Correct number of sequences
Standard Error 0.40
|
15.42 Correct number of sequences
Standard Error 0.39
|
16.19 Correct number of sequences
Standard Error 0.39
|
PRIMARY outcome
Timeframe: 12, and 24 weeksCombined Z score of proportion of words recalled, proportion of words recognised, and proportion of pictures recognised. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A negative change value reflects a decrease in memory or a worse outcome and a positive change value reflects an increase in memory or a better outcome
Outcome measures
| Measure |
Placebo
n=27 Participants
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 450mg
n=28 Participants
Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 900 mg
n=29 Participants
Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 900 mg: Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
|
Wild Blueberry Extract 100mg
n=28 Participants
Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
|
|---|---|---|---|---|
|
Combined Z Score of Delayed Words Recalled, Words Recognised, and Pictures Recognised.
12 Weeks
|
0.19 z-score
Standard Error 0.11
|
0.08 z-score
Standard Error 0.11
|
0.02 z-score
Standard Error 0.11
|
0.28 z-score
Standard Error 0.11
|
|
Combined Z Score of Delayed Words Recalled, Words Recognised, and Pictures Recognised.
24 Weeks
|
0.31 z-score
Standard Error 0.09
|
0.13 z-score
Standard Error 0.09
|
0.33 z-score
Standard Error 0.08
|
0.2 z-score
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 12, and 24 weeksCombined Z Score of Mean Reaction Time Scores for Incongruent Attention Network and Stroop Task Trials. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A negative change value reflects a decrease in memory or a worse outcome and a positive change value reflects an increase in memory or a better outcome.
Outcome measures
| Measure |
Placebo
n=27 Participants
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 450mg
n=28 Participants
Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 900 mg
n=29 Participants
Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 900 mg: Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
|
Wild Blueberry Extract 100mg
n=28 Participants
Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
|
|---|---|---|---|---|
|
Combined Z Score of Mean Reaction Time Scores for Incongruent Attention Network and Stroop Task Trials.
12 Weeks
|
0.003 z-score
Standard Error 0.067
|
0.009 z-score
Standard Error 0.068
|
-0.137 z-score
Standard Error 0.064
|
-0.037 z-score
Standard Error 0.067
|
|
Combined Z Score of Mean Reaction Time Scores for Incongruent Attention Network and Stroop Task Trials.
24 Weeks
|
-0.101 z-score
Standard Error 0.065
|
-0.176 z-score
Standard Error 0.066
|
-0.129 z-score
Standard Error 0.062
|
-0.075 z-score
Standard Error 0.065
|
SECONDARY outcome
Timeframe: 12, and 24 weeksCombined Z Score of Proportion of Immediate Words Recalled, Number of Correct Serial 3 and Serial 7 Subtractions, and the Coefficient of the Line for Reaction Time by Length of Sting During Probe Recall. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A negative change value reflects a decrease in memory or a worse outcome and a positive change value reflects an increase in memory or a better outcome
Outcome measures
| Measure |
Placebo
n=27 Participants
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 450mg
n=28 Participants
Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 900 mg
n=29 Participants
Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 900 mg: Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
|
Wild Blueberry Extract 100mg
n=28 Participants
Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
|
|---|---|---|---|---|
|
Combined Z Score of Proportion of Immediate Words Recalled, Number of Correct Serial 3 and Serial 7 Subtractions, Sternberg Task Coefficent of the Line
12 Weeks
|
0.12 z-score
Standard Error 0.09
|
-0.03 z-score
Standard Error 0.08
|
-0.13 z-score
Standard Error 0.08
|
0.03 z-score
Standard Error 0.08
|
|
Combined Z Score of Proportion of Immediate Words Recalled, Number of Correct Serial 3 and Serial 7 Subtractions, Sternberg Task Coefficent of the Line
24 Weeks
|
0.1 z-score
Standard Error 0.07
|
-0.01 z-score
Standard Error 0.07
|
-0.04 z-score
Standard Error 0.07
|
0.02 z-score
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 12, and 24 weeks.LMM analysis of intervention group x 12 and 24 wk test session. Baseline blood pressure entered as a covariate.
Outcome measures
| Measure |
Placebo
n=27 Participants
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 450mg
n=28 Participants
Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 900 mg
n=29 Participants
Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 900 mg: Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
|
Wild Blueberry Extract 100mg
n=28 Participants
Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
|
|---|---|---|---|---|
|
Systolic Blood Pressure
12 Weeks
|
124.11 mmHg
Standard Error 2.09
|
124.51 mmHg
Standard Error 2.05
|
125.16 mmHg
Standard Error 2.03
|
118.62 mmHg
Standard Error 2.15
|
|
Systolic Blood Pressure
24 Weeks
|
119.63 mmHg
Standard Error 2.05
|
122.39 mmHg
Standard Error 2.01
|
119.79 mmHg
Standard Error 1.99
|
114.72 mmHg
Standard Error 2.11
|
SECONDARY outcome
Timeframe: 12, and 24 weeksLMM analysis of intervention group x 12 and 24 wk test session. Baseline blood pressure entered as a covariate.
Outcome measures
| Measure |
Placebo
n=27 Participants
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 450mg
n=28 Participants
Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 900 mg
n=29 Participants
Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 900 mg: Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
|
Wild Blueberry Extract 100mg
n=28 Participants
Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
|
|---|---|---|---|---|
|
Diastolic Blood Pressure
12 Weeks
|
72.70 mmHg
Standard Error 1.16
|
74.85 mmHg
Standard Error 1.13
|
72.30 mmHg
Standard Error 1.09
|
72.30 mmHg
Standard Error 1.13
|
|
Diastolic Blood Pressure
24 Weeks
|
71.71 mmHg
Standard Error 1.21
|
73.54 mmHg
Standard Error 1.18
|
71.23 mmHg
Standard Error 1.13
|
71.45 mmHg
Standard Error 1.17
|
SECONDARY outcome
Timeframe: 12, and 24 weeks.LMM analysis of intervention group x 12 and 24 wk test session. Baseline heart rate entered as a covariate.
Outcome measures
| Measure |
Placebo
n=27 Participants
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 450mg
n=28 Participants
Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 900 mg
n=29 Participants
Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 900 mg: Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
|
Wild Blueberry Extract 100mg
n=28 Participants
Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
|
|---|---|---|---|---|
|
Heart Rate
24 Weeks
|
68.62 beats/min
Standard Error 1.22
|
67.47 beats/min
Standard Error 1.18
|
67.11 beats/min
Standard Error 1.15
|
70.04 beats/min
Standard Error 1.19
|
|
Heart Rate
12 Weeks
|
68.33 beats/min
Standard Error 1.02
|
69.16 beats/min
Standard Error 0.98
|
66.07 beats/min
Standard Error 0.95
|
67.56 beats/min
Standard Error 0.99
|
SECONDARY outcome
Timeframe: 12, and 24 weeksAs measured by the positive mood scale derived from the Positive and Negative Affect Schedule. This measure consists of 10 words relating to positive affect. The participants is asked to rate how they feel about each word from 1 (very slightly/not at all) to 5 (extremely) with a minimum score of 5 and maximum of 50. A higher score relates to higher positive affect.
Outcome measures
| Measure |
Placebo
n=27 Participants
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 450mg
n=28 Participants
Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 900 mg
n=29 Participants
Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 900 mg: Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
|
Wild Blueberry Extract 100mg
n=28 Participants
Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
|
|---|---|---|---|---|
|
Positive Affect Score
12 Weeks
|
31.29 units on a scale
Standard Error 0.92
|
31.18 units on a scale
Standard Error 0.90
|
32.10 units on a scale
Standard Error 0.92
|
31.30 units on a scale
Standard Error 0.92
|
|
Positive Affect Score
24 Weeks
|
31.06 units on a scale
Standard Error 0.84
|
31.07 units on a scale
Standard Error 0.82
|
30.83 units on a scale
Standard Error 0.83
|
31.96 units on a scale
Standard Error 0.83
|
SECONDARY outcome
Timeframe: 12, and 24 weeks.As measured by the negative mood scale derived from the Positive and Negative Affect Schedule. This measure consists of 10 words relating to negative affect. The participants is asked to rate how they feel about each word from 1 (very slightly/not at all) to 5 (extremely) with a minimum score of 5 and maximum of 50. A higher score relates to higher negative affect.
Outcome measures
| Measure |
Placebo
n=27 Participants
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 450mg
n=28 Participants
Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine + 2.5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 900 mg
n=29 Participants
Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
Wild Blueberry Powder - 900 mg: Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
|
Wild Blueberry Extract 100mg
n=28 Participants
Formulation containing containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
|
|---|---|---|---|---|
|
Negative Affect Score
12 Weeks
|
12.04 units on a scale
Standard Error 0.44
|
13.14 units on a scale
Standard Error 0.42
|
11.72 units on a scale
Standard Error 0.42
|
11.53 units on a scale
Standard Error 0.44
|
|
Negative Affect Score
24 Weeks
|
12.17 units on a scale
Standard Error 0.41
|
12.18 units on a scale
Standard Error 0.40
|
12.11 units on a scale
Standard Error 0.40
|
11.57 units on a scale
Standard Error 0.41
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Wild Blueberry Powder - 500mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wild Blueberry Powder - 1000 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Wild Blueberry Extract 111mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=30 participants at risk
Placebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 500mg
n=30 participants at risk
Wild Blueberry Powder - 450mg: Formulation containing 225 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione + 250 mg placebo powder, once daily, in a 2-hard capsule regimen
|
Wild Blueberry Powder - 1000 mg
n=31 participants at risk
Wild Blueberry Powder - 1000 mg: Formulation containing 900 mg wild blueberry powder + 90 mg L-Cysteine + 10 mg L-Glutathione once daily, in a 2-hard capsule regimen
|
Wild Blueberry Extract 111mg
n=31 participants at risk
Wild Blueberry extract 100mg: Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 889 mg of placebo, once daily, in a 2-hard capsule regimen
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea / Looser Stool
|
3.3%
1/30 • 6 months
|
0.00%
0/30 • 6 months
|
3.2%
1/31 • 6 months
|
6.5%
2/31 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place