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Purpose: The purpose of this study is to examine the effect of blueberry consumption on cognitive decline and body composition in humans.
Hypothesis 1: Adults with mild cognitive decline who consume blueberries will experience an improvement in cognitive abilities as measured by a standardized battery of tests, relative to those who consume a placebo.
Hypothesis 2: Adults with mild cognitive decline who consume blueberries will evidence an increase in processing speed and an improvement in memory abilities as measured in an electrophysiological paradigm and compared to those who consume a placebo.
Hypothesis 3: Daily intake of 35 g freeze-dried blueberries will improve body composition (fat mass vs. lean mass).
Hypothesis 4: Daily intake of 35 g freeze-dried blueberries will decrease oxidative stress and inflammatory markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blueberry Group | Experimental | 37 grams of dehydrated blueberries daily for 6 months |
|
| Placebo Group | Placebo Comparator | 37 grams of dextrose powder daily for 6 months |
|
| Reference Group | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freeze-dried blueberries | Dietary Supplement | Wild blueberries, freeze-dried and pulverized |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive test performance | Measured by CANTAB | Baseline, 180 days |
| Change in brain activity (N200, P300) related to cognitive abilities as measured by event-related potentials (ERP) | Recognition memory, speed of processing, and memory consolidation as measured by the electrophysiological technique known as event-related potentials (ERP) | Baseline, 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass distribution | DXA scans to measure body composition at baseline and outcome will be compared for differences | Baseline, 180 days |
| Change in oxidative stress and inflammatory markers as measured in blood and urine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol L Cheatham, Ph.D. | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrition Research Institute | Kannapolis | North Carolina | 28081 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36066009 | Derived | Cheatham CL, Canipe LG 3rd, Millsap G, Stegall JM, Chai SC, Sheppard KW, Lila MA. Six-month intervention with wild blueberries improved speed of processing in mild cognitive decline: a double-blind, placebo-controlled, randomized clinical trial. Nutr Neurosci. 2023 Oct;26(10):1019-1033. doi: 10.1080/1028415X.2022.2117475. Epub 2022 Sep 6. | |
| 29523147 |
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| Dextrose Placebo | Dietary Supplement | Placebo developed to closely match blueberry powder. |
|
Oxidative stress and inflammatory markers will be measured in blood and compared between baseline and outcome.
| Baseline, 180 days |
| Sheppard KW, Cheatham CL. Omega-6/omega-3 fatty acid intake of children and older adults in the U.S.: dietary intake in comparison to current dietary recommendations and the Healthy Eating Index. Lipids Health Dis. 2018 Mar 9;17(1):43. doi: 10.1186/s12944-018-0693-9. |