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| Name | Class |
|---|---|
| The Peanut Institute | OTHER |
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The study will test the effects of Peanuts on task-related brain activation and cognitive functions in older adults with memory complaints.
The purpose of the study is to determine the effects of peanuts on cognitive performance and task-related brain activation on functional magnetic resonance imaging (fMRI) in older adults. The specific aim of the study is to explore the neuroprotective effects of a peanut-enriched diet (2-3 oz of peanuts to replace 20% of the total energy of the habitual diet) for 12 weeks compared to a peanut-excluded habitual diet in elderly men and women with increased risk for CVD and self-reported memory complaints. The study population is older adults 60-80 years in age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peanut Group | Active Comparator | Peanuts: 2-3 ounces per day to replace 20% of daily energy intake |
|
| Control Group | Active Comparator | Habitual diet abstain from eating peanuts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanuts | Dietary Supplement | 2-3 ounces of peanuts to replace 20% of total daily energy intake |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes from baseline in Brian activation | Changes will be assessed by Functional MRI (fMRI) on participants. there is no units of measure | baseline to 12 weeks |
| changes from baseline serum markers of inflammation | changes in serum inflammation markers which includes hs-CRP, IL-6, TNF-α, ICAM/VCAM, eSelectin, F2-isoprostanes, 8-hydroxy-deoxyguanosine (8-OH-dG) will all be assessed using ELISA | baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| changes from baseline in global cognitive composite score | The composite score will be calculated using the scores from the tests listed below. We will calculate the standardized scores of each test as the score of each participant minus the group mean and divide by its standard deviation. The composite score is the mean of the standardized scores. the 5 tests are: Rey Auditory Verbal Learning Test (RAVLT), Brief Visuospatial Memory Test, Digit Span, FAS Word Fluency, Symbol Digit Modalities Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sujatha Rajaram, PhD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University School of Public Health | Loma Linda | California | 92350 | United States |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a free living , randomized, controlled, parallel design study with 30 subjects, who will be randomized to either receive peanuts or abstain from them for 12 weeks.
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The participants will be aware if they received the intervention or not, however, the cognitive testers and FMRI techs would not be aware of the participant randomization group and neither will the data analyst.
| Habitual Diet | Other | continue with habitual diet and abstain from eating peanuts |
|
| baseline to 12 weeks |
| Change in serum brain-derived neurotrophic factor (pg/mL) | changes in serum brain-derived neurotrophic factor (pg/mL) assessed by ELISA | baseline to 12 weeks |