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Trial · Interventional

CompletedNot applicableResults postedRegistry data

An Investigation Into the Effects of a Wild Blueberry Powder and a Wild Blueberry Extract on Cognition in Older Adults

NCTNCT02446314 (opens ClinicalTrials.gov in a new tab)Other idRDG-001
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Glutathione, does not test it. It appears in the summary.

Overview

Status
Completed
Phase
Not applicable
Enrollment
122 participants (actual)
Sponsor
University of Reading · Other
Design
Randomized · Double masking
Countries
1 country

United Kingdom

Start
May 2015
Primary completion
Nov 2016
Completion
Jul 2017
First posted
18 May 2015 (estimated)
Last update posted
8 Aug 2019
Conditions
Cognitive Decline

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. N/A

    An Investigation Into the Effects of a Wild Blueberry Powder and a Wild Blueberry Extract on Cognition in Older Adults

    NCT02446314

    May 2015 to Jul 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine whether a 6 month dietary intervention with wild blueberry powder and extract stabilised with L-cysteine and L-glutathione have an effect on cognitive performance in participants aged between 65 - 80.

Interventions

  • PlaceboDietary supplement
  • Wild Blueberry Powder - 450mgDietary supplement
  • Wild Blueberry Powder - 900 mgDietary supplement
  • Wild Blueberry extract 100mgDietary supplement

Arms4

  • Placebo comparator

    Placebo

    Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen

  • Experimental

    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

  • Experimental

    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

  • Experimental

    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

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Proportion of Words Correctly Recognised.

    Time frame · 12, and 24 weeks

    Registry description

    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.

  2. Total Number of Correct Sequences Recalled

    Time frame · 12, and 24 weeks

    Registry description

    Participants 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.

  3. Combined Z Score of Delayed Words Recalled, Words Recognised, and Pictures Recognised.

    Time frame · 12, and 24 weeks

    Registry description

    Combined 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

Secondary outcomes(7)

  1. Combined Z Score of Mean Reaction Time Scores for Incongruent Attention Network and Stroop Task Trials.

    Time frame · 12, and 24 weeks

    Registry description

    Combined 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.

  2. Combined Z Score of Proportion of Immediate Words Recalled, Number of Correct Serial 3 and Serial 7 Subtractions, Sternberg Task Coefficent of the Line

    Time frame · 12, and 24 weeks

    Registry description

    Combined 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

  3. Systolic Blood Pressure

    Time frame · 12, and 24 weeks.

    Registry description

    LMM analysis of intervention group x 12 and 24 wk test session. Baseline blood pressure entered as a covariate.

  4. Diastolic Blood Pressure

    Time frame · 12, and 24 weeks

    Registry description

    LMM analysis of intervention group x 12 and 24 wk test session. Baseline blood pressure entered as a covariate.

  5. Heart Rate

    Time frame · 12, and 24 weeks.

    Registry description

    LMM analysis of intervention group x 12 and 24 wk test session. Baseline heart rate entered as a covariate.

  6. Positive Affect Score

    Time frame · 12, and 24 weeks

    Registry description

    As 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.

  7. Negative Affect Score

    Time frame · 12, and 24 weeks.

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 12, and 24 weeks

Proportion of Words Correctly Recognised.

GroupValue (proportion of words correctly recognised)Spread
Placebo0.860.02
Wild Blueberry Powder - 450mg0.850.02
Wild Blueberry Powder - 900 mg0.790.02
Wild Blueberry Extract 100mg0.900.02
Primary outcomeMean· 12, and 24 weeks

Total Number of Correct Sequences Recalled

GroupValue (Correct number of sequences)Spread
Placebo15.150.41
Wild Blueberry Powder - 450mg14.270.40
Wild Blueberry Powder - 900 mg15.420.39
Wild Blueberry Extract 100mg16.190.39
Primary outcomeMean· 12, and 24 weeks

Combined Z Score of Delayed Words Recalled, Words Recognised, and Pictures Recognised.

GroupValue (z-score)Spread
Placebo0.190.11
Wild Blueberry Powder - 450mg0.080.11
Wild Blueberry Powder - 900 mg0.020.11
Wild Blueberry Extract 100mg0.280.11
Secondary and other outcome results(5)
Secondary outcomeMean· 12, and 24 weeks

Combined Z Score of Mean Reaction Time Scores for Incongruent Attention Network and Stroop Task Trials.

GroupValue (z-score)Spread
Placebo0.0030.067
Wild Blueberry Powder - 450mg0.0090.068
Wild Blueberry Powder - 900 mg-0.1370.064
Wild Blueberry Extract 100mg-0.0370.067
Secondary outcomeMean· 12, and 24 weeks

Combined Z Score of Proportion of Immediate Words Recalled, Number of Correct Serial 3 and Serial 7 Subtractions, Sternberg Task Coefficent of the Line

GroupValue (z-score)Spread
Placebo0.120.09
Wild Blueberry Powder - 450mg-0.030.08
Wild Blueberry Powder - 900 mg-0.130.08
Wild Blueberry Extract 100mg0.030.08
Secondary outcomeMean· 12, and 24 weeks.

Systolic Blood Pressure

GroupValue (mmHg)Spread
Placebo124.112.09
Wild Blueberry Powder - 450mg124.512.05
Wild Blueberry Powder - 900 mg125.162.03
Wild Blueberry Extract 100mg118.622.15
Secondary outcomeMean· 12, and 24 weeks

Diastolic Blood Pressure

GroupValue (mmHg)Spread
Placebo72.701.16
Wild Blueberry Powder - 450mg74.851.13
Wild Blueberry Powder - 900 mg72.301.09
Wild Blueberry Extract 100mg72.301.13
Secondary outcomeMean· 12, and 24 weeks.

Heart Rate

GroupValue (beats/min)Spread
Placebo68.331.02
Wild Blueberry Powder - 450mg69.160.98
Wild Blueberry Powder - 900 mg66.070.95
Wild Blueberry Extract 100mg67.560.99

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboPlacebo: Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen0 / 300 / 301 / 30
Wild Blueberry Powder - 500mgWild 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 regimen0 / 300 / 300 / 30
Wild Blueberry Powder - 1000 mgWild 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 regimen0 / 310 / 311 / 31
Wild Blueberry Extract 111mgWild 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 regimen0 / 310 / 312 / 31

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultWhyte AR, Cheng N, Fromentin E, Williams CM. A Randomized, Double-Blinded, Placebo-Controlled Study to Compare the Safety and Efficacy of Low Dose Enhanced Wild Blueberry Powder and Wild Blueberry Extract (ThinkBlue) in Maintenance of Episodic and Working Memory in Older Adults. Nutrients. 2018 May 23;10(6):660. doi: 10.3390/nu10060660. PMID 29882843

Eligibility

Who could join, as posted.

Sex
All
Age
from 65 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Overall healthy volunteers as proven by medical history and/or physical examination and of all ethnicity and socioeconomic status * Free-living * Subjects with subjective memory complaints * MMSE: 24-30 * Subjects are willing to maintain their normal eating habits and exercise habits to avoid changes in body weight over the duration of the study * Being willing to complete the food diaries and questionnaires * Able to give signed written informed consent * Signed informed consent form Exclusion Criteria: * Use of complementary and alternative medicine * History of metabolic disorder, diabetes, substance abuse * Subjects diagnosed with psychiatric or neurological conditions * Subjects using medications that might affect the outcome measures (such as antidepressant and sleeping medication), or planned changes

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