Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02446314
Recruitment Status : Completed
First Posted : May 18, 2015
Last Update Posted : August 17, 2017
Sponsor:
Collaborator:
Naurex, Inc, an affiliate of Allergan plc
Information provided by (Responsible Party):
Dr Claire Williams, University of Reading

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.

Condition or disease Intervention/treatment Phase
Cognitive Decline Dietary Supplement: Placebo Dietary Supplement: Wild Blueberry Powder - 450mg Dietary Supplement: Wild Blueberry Powder - 900 mg Dietary Supplement: Wild Blueberry extract 100mg Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Placebo-controlled Study Investigating the Effects of a Wild Blueberry Powder and a Wild Blueberry Extract on Cognition in Older Adults
Study Start Date : May 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
Dietary Supplement: 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
Dietary Supplement: 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
Dietary Supplement: 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

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
Dietary Supplement: 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




Primary Outcome Measures :
  1. Cognitive Performance [ Time Frame: Baseline, 12, and 24 weeks ]
    Extensive cognitive test battery including tasks measuring memory performance such as the Reys Auditory Verbal Learning Task and executive function such as the Word/Color Stroop task.


Secondary Outcome Measures :
  1. Mood [ Time Frame: Baseline, 12, and 24 weeks. ]
    Mood will be measured by use of the Positive and Negative Affect Scale.

  2. Heart Rate [ Time Frame: Baseline, 12, and 24 weeks. ]
  3. Blood Pressure [ Time Frame: Baseline, 12, and 24 weeks. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446314


Locations
Layout table for location information
United Kingdom
University of Reading
Reading, Berkshire, United Kingdom, RG6 6AH
Sponsors and Collaborators
University of Reading
Naurex, Inc, an affiliate of Allergan plc
Investigators
Layout table for investigator information
Principal Investigator: Claire M Williams, PhD University of Reaiding
Study Director: Emilie Fromentin, PhD NATURIEX-DBS,, LLC

Publications:
Layout table for additonal information
Responsible Party: Dr Claire Williams, Associate Professor in Behavioural Neuroscience, University of Reading
ClinicalTrials.gov Identifier: NCT02446314     History of Changes
Other Study ID Numbers: RDG-001
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders