Mild Cognitive Decline Clinical Trial
— BERRYOfficial title:
The Effect of Blueberry Consumption on Cognition and Body Composition in Elderly Who Are Experiencing Mild Cognitive Decline
| NCT number | NCT01515098 |
| Other study ID # | 11-2075 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2012 |
| Est. completion date | March 2015 |
| Verified date | March 2022 |
| Source | University of North Carolina, Chapel Hill |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 123 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 65 Years to 79 Years |
| Eligibility | Inclusion Criteria: - Men and women age 65 and older - BMI between 18.5 and 34.5 - Close individual to report memory decline Exclusion Criteria: - History of central nervous system or psychiatric disorders - Dementia or Alzheimer's diagnosis - Diabetes - Smoking >20 cigarettes/day - Gastrointestinal/digestive disorders - Uncontrolled chronic disease |
| Country | Name | City | State |
|---|---|---|---|
| United States | Nutrition Research Institute | Kannapolis | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| University of North Carolina, Chapel Hill |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in cognitive test performance | Measured by CANTAB | Baseline, 180 days | |
| Primary | 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 | |
| Secondary | Change in body mass distribution | DXA scans to measure body composition at baseline and outcome will be compared for differences | Baseline, 180 days | |
| Secondary | Change in oxidative stress and inflammatory markers as measured in blood and urine | Oxidative stress and inflammatory markers will be measured in blood and compared between baseline and outcome. | Baseline, 180 days |