Cognition, Inflammation
Conditions
Keywords
Peanuts, cognition, inflammation, oxidative stress
Brief summary
The study will test the effects of Peanuts on task-related brain activation and cognitive functions in older adults with memory complaints.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPeanuts
2-3 ounces of peanuts to replace 20% of total daily energy intake
OTHERHabitual Diet
continue with habitual diet and abstain from eating peanuts
Sponsors
The Peanut Institute
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Non-demented elderly between 60-80 years of age * Self-reported memory complaints * Two cardiovascular risk factors * Stable weight for at least 6 months prior to recruitment
Exclusion criteria
* Peanut allergy * Smoker * Endocrine, metabolic and neuropsychological disorders * Ineligible to get an MRI * Consuming more than 3 servings/week of nuts including peanuts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes from baseline in Brian activation | baseline to 12 weeks | Changes will be assessed by Functional MRI (fMRI) on participants. there is no units of measure |
| changes from baseline serum markers of inflammation | baseline to 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes from baseline in global cognitive composite score | baseline to 12 weeks | 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 |
| Change in serum brain-derived neurotrophic factor (pg/mL) | baseline to 12 weeks | changes in serum brain-derived neurotrophic factor (pg/mL) assessed by ELISA |
Countries
United States
Outcome results
None listed