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| Name | Class |
|---|---|
| Wild Blueberry Association of North America | OTHER |
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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.
Interventions: Flavonoid drink and a matched placebo will be used in this study. Flavonoid drink will contain approximately, 13g of freeze dried wild blueberry powder, containing 250mg of anthocyanin flavonoid, mixed with 170ml water and flavored with 30ml 'Rock's Organic Orange Squash' as it has a low flavonoid content. The placebo drink will contain placebo powder matched for vitamin C (45mg), glucose (4.52g) and fructose (4.79g), mixed with 170ml of water and 30ml 'Rock's Organic Orange Squash'. Participants will be randomly allocated to either placebo or treatment. Participants will be instructed to consume the drink every morning for 4 weeks. The powder will be prepared and sealed in opaque packets. Participants will be provided with 2 weeks worth of supplies at baseline and then in week 2. Parents will be provided with instructions on how to prepare the drinks in addition to supplies such as opaque straws and containers. Assessment of left-over product will be conducted in 2 weeks to allow for continued compliance verification.
Procedure: the study comprises of a screen and four visits, including a familiarization week and 2 test visits.
Participants may stop the study treatment without stating any reason at any time during the study. In addition, a participant will be withdrawn from the study if a volunteer or parents request a discontinuation, participant exhibits a serious adverse event to any component of the test product, an illness emerges and/or the investigator's opinion is that withdrawal is appropriate and in the best interest of the participant. If a participant withdraws from the study, participants will be encouraged to make a final visit as soon as possible, irrespective of the reason for withdrawal, to complete a final battery of cognitive tasks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Formulation containing approximately 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C |
|
| Wild Blueberry Power-13g | Experimental | Formulation containing approximately 250mg of anthocyanin+ 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wild Blueberry Powder-13g | Dietary Supplement | Formulation containing approximately 250mg of anthocyanin+ 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rumination | Measured using Rumination Response Scale. | 0 and 4 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Reading | Reading | Berkshire | RG6 6AL | United Kingdom |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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participants will be assigned to either a Placebo or Blueberry (treatment) drink, in parallel for the duration of the study
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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.
| Placebo | Dietary Supplement | Formulation containing approximately 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C |
|
| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |