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

NCT02446314 | Completed Results

• 1 other identifier: RDG-001
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Decline

Outcome Measures

Primary Outcomes (3)

• Proportion of Words Correctly Recognised.

  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.

  12, and 24 weeks

• Total Number of Correct Sequences Recalled

  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.

  12, and 24 weeks

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

  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

  12, and 24 weeks

Secondary Outcomes (7)

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

  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

  12, and 24 weeks

• Systolic Blood Pressure

  12, and 24 weeks.

• Diastolic Blood Pressure

  12, and 24 weeks

• Heart Rate

  12, and 24 weeks.

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Wild Blueberry Powder - 450mg

EXPERIMENTAL

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

Dietary Supplement: Wild Blueberry Powder - 450mg

Wild Blueberry Powder - 900 mg

EXPERIMENTAL

Formulation containing containing 450 mg wild blueberry powder + 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen

Dietary Supplement: Wild Blueberry Powder - 900 mg

Wild Blueberry extract 100mg

EXPERIMENTAL

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

Dietary Supplement: Wild Blueberry extract 100mg

Interventions

Placebo DIETARY_SUPPLEMENT

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

Placebo

Wild Blueberry Powder - 450mg DIETARY_SUPPLEMENT

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

Wild Blueberry Powder - 900 mg DIETARY_SUPPLEMENT

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 Powder - 900 mg

Wild Blueberry extract 100mg DIETARY_SUPPLEMENT

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

Wild Blueberry extract 100mg

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead
• Naurex, Inc, an affiliate of Allergan plc: collaborator

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AH, United Kingdom

Location

Related Publications (6)

• How, P.S., Ellis, J.A., Neshatdoust, S., Spencer, J.P.E. (2008). The impact of plant-derived flavonoids on mood, memory and motor skills in healthy older UK adults. Proceedings of the Nutrition Society, 67, E316.

  BACKGROUND

• Krikorian R, Shidler MD, Nash TA, Kalt W, Vinqvist-Tymchuk MR, Shukitt-Hale B, Joseph JA. Blueberry supplementation improves memory in older adults. J Agric Food Chem. 2010 Apr 14;58(7):3996-4000. doi: 10.1021/jf9029332.

  PMID: 20047325 BACKGROUND

• Macready AL, Kennedy OB, Ellis JA, Williams CM, Spencer JP, Butler LT. Flavonoids and cognitive function: a review of human randomized controlled trial studies and recommendations for future studies. Genes Nutr. 2009 Dec;4(4):227-42. doi: 10.1007/s12263-009-0135-4. Epub 2009 Aug 13.

  PMID: 19680703 BACKGROUND

• Rendeiro C, Vauzour D, Kean RJ, Butler LT, Rattray M, Spencer JP, Williams CM. Blueberry supplementation induces spatial memory improvements and region-specific regulation of hippocampal BDNF mRNA expression in young rats. Psychopharmacology (Berl). 2012 Oct;223(3):319-30. doi: 10.1007/s00213-012-2719-8. Epub 2012 May 9.

  PMID: 22569815 BACKGROUND

• Rendeiro C, Vauzour D, Rattray M, Waffo-Teguo P, Merillon JM, Butler LT, Williams CM, Spencer JP. Dietary levels of pure flavonoids improve spatial memory performance and increase hippocampal brain-derived neurotrophic factor. PLoS One. 2013 May 28;8(5):e63535. doi: 10.1371/journal.pone.0063535. Print 2013.

  PMID: 23723987 BACKGROUND

• Whyte 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 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Prof Claire Williams
• Organization: The University of Reading

claire.williams@reading.ac.uk

0118 378 7540

Study Officials

• Claire M Williams, PhD

  University of Reaiding

  PRINCIPAL INVESTIGATOR

• Emilie Fromentin, PhD

  NATURIEX-DBS,, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Behavioural Neuroscience

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 18, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: July 1, 2017
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-06

Locations

GB (1)