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An Investigation Into the Effects of Blueberry Anthocyanin on Cognitive Functioning and Mood in Adolescents.

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: NCT03119597
Recruitment Status : Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : July 4, 2018
Sponsor:
Collaborator:
Wild Blueberry Association of North America (WBANA)
Information provided by (Responsible Party):
Prof Claire Williams, University of Reading

Brief Summary:
The purpose of this study is to determine whether a 4-week dietary intervention with wild blueberry powder can have an effect on cognitive performance in participants aged between 13-17.

Condition or disease Intervention/treatment Phase
Depression Dietary Supplement: Wild Blueberry Powder-13g Dietary Supplement: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: participants will be assigned to either a Placebo or Blueberry (treatment) drink, in parallel for the duration of the study
Masking: Double (Participant, Investigator)
Masking Description: Neither the participants nor the researchers will be aware of which participants are receiving treatment or placebo. Participants and their parents will be debriefed on the last test day.
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled Study Investigating the Effects of Blueberry Anthocyanin on Cognitive Functioning and Mood in Adolescents.
Actual Study Start Date : January 12, 2017
Actual Primary Completion Date : November 27, 2017
Estimated Study Completion Date : December 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Formulation containing approximately 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C
Dietary Supplement: Placebo
Formulation containing approximately 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C

Experimental: Wild Blueberry Power-13g
Formulation containing approximately 250mg of anthocyanin+ 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C
Dietary Supplement: Wild Blueberry Powder-13g
Formulation containing approximately 250mg of anthocyanin+ 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C




Primary Outcome Measures :
  1. Change in Working Memory performance [ Time Frame: 0, 2 and 4 weeks ]
    Keep tract task: measuring working memory performance

  2. Change in Mood [ Time Frame: 0, 2 and 4 weeks ]
    measured by use of PANAS

  3. Change in verbal fluency [ Time Frame: 0, 2 and 4 weeks ]
    Controlled oral word association task: measuring working memory performance

  4. Change in Cognitive Accuracy [ Time Frame: 0, 2 and 4 weeks ]
    Modified Flanker Task: measuring accuracy

  5. Change in reaction time [ Time Frame: 0, 2 and 4 weeks ]
    Modified Flanker Task: measuring reaction time

  6. Change in Depression [ Time Frame: 0 and 4 weeks ]
    measured by use of MFQ

  7. Change in Anxiety [ Time Frame: 0 and 4 weeks ]
    measured by use of RCADS


Secondary Outcome Measures :
  1. Change in Rumination [ Time Frame: 0 and 4 week ]
    Measured using Rumination Response Scale.



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
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
  • Participants at risk of depression or healthy as assessed by MFQ (score 27 or above and score 14 or below)
  • Able to get a parent or guardian to give signed written informed consent in addition to they themselves giving informed assent

Exclusion Criteria:

  • Use of complementary and alternative medicine
  • History of metabolic disorder, diabetes, or other medical conditions.
  • Participants using medications that might affect the outcome measures, such as antidepressant and sleeping medication.
  • Participants who score between 14 and 27 on the MFQ.

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): NCT03119597


Locations
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United Kingdom
University of Reading
Reading, Berkshire, United Kingdom, RG6 6AL
Sponsors and Collaborators
University of Reading
Wild Blueberry Association of North America (WBANA)

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Responsible Party: Prof Claire Williams, Professor in Behavioral Neuroscience, University of Reading
ClinicalTrials.gov Identifier: NCT03119597     History of Changes
Other Study ID Numbers: RDG002
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof Claire Williams, University of Reading:
low mood, depression

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Vitamins
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents