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

NCT03119597 | Completed DMC

• 1 other identifier: RDG002
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

low mood, depression

Outcome Measures

Primary Outcomes (7)

• Change in Working Memory performance

  Keep tract task: measuring working memory performance

  0, 2 and 4 weeks

• Change in Mood

  measured by use of PANAS

  0, 2 and 4 weeks

• Change in verbal fluency

  Controlled oral word association task: measuring working memory performance

  0, 2 and 4 weeks

• Change in Cognitive Accuracy

  Modified Flanker Task: measuring accuracy

  0, 2 and 4 weeks

• Change in reaction time

  Modified Flanker Task: measuring reaction time

  0, 2 and 4 weeks

• Change in Depression

  measured by use of MFQ

  0 and 4 weeks

• Change in Anxiety

  measured by use of RCADS

  0 and 4 weeks

Secondary Outcomes (1)

• Change in Rumination

  0 and 4 week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Formulation containing approximately 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C

Dietary Supplement: Placebo

Wild Blueberry Power-13g

EXPERIMENTAL

Formulation containing approximately 250mg of anthocyanin+ 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C

Dietary Supplement: Wild Blueberry Powder-13g

Interventions

Wild Blueberry Powder-13g DIETARY_SUPPLEMENT

Formulation containing approximately 250mg of anthocyanin+ 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C

Wild Blueberry Power-13g

Placebo DIETARY_SUPPLEMENT

Formulation containing approximately 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C

Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Reading: lead
• Wild Blueberry Association of North America: collaborator

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

Location

MeSH Terms

Conditions

Depression; Consciousness Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Behavioral Neuroscience

Model Details: participants will be assigned to either a Placebo or Blueberry (treatment) drink, in parallel for the duration of the study

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 18, 2017
• Study Start: January 12, 2017
• Primary Completion: November 27, 2017
• Study Completion: December 22, 2018
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)