Effects of Peanut Intake on Cognitive Functions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Peanut Intake on Task-related Brain Activation and Cognitive Functions in Older Adults With Memory Complaints: A Randomized Controlled Study

Conditions
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Cognition, Inflammation

Intervention / Treatment
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* Dietary Supplement: Peanuts
* Other: Habitual Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peanut Group<br>Peanuts: 2-3 ounces per day to replace 20% of daily energy intake | Dietary Supplement: Peanuts<br>* 2-3 ounces of peanuts to replace 20% of total daily energy intake<br>|
| Active Comparator: Control Group<br>Habitual diet abstain from eating peanuts | Other: Habitual Diet<br>* continue with habitual diet and abstain from eating peanuts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peanuts, cognition, inflammation, oxidative stress