The Effect of Consumption of Almonds and Snack Mix Daily for 6 Months on Cognitive Function in Older Adults

Study Overview
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Brief Summary
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Cognitive impairment is also a major risk factor for development of dementia later in life. Findings from recent studies suggest that the there are many nutrients contained in foods that may be important in cognitive function in the elderly. This study evaluates long-term intervention with almonds and snack mix as a treatment strategy for age-related cognitive impairment which could possibly prevent the onset of dementia. The proposed study is designed as a randomized, placebo controlled trial that tests the effects of 6 month supplementation with 1.5 or 3 ounces of almonds or 3 ounces of shortbread containing coconut oil on cognitive function in older adults. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation.

Detailed Description
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The study is designed as a controlled trial that tests the effects of 6 month supplementation with 1.5 or 3 ounces of almonds or 3 ounces of snack mix a day on cognitive function in older adults. Subjects will be randomly assigned to one of the three groups. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation. Participants will be recruited from community-dwelling men and women aged greater than of equal to 50 yr and less than or equal to 75 years and potential participants will be screened to meet cognitive and functional criteria. Participants will be pre-screened by telephone; those who appear to meet criteria will undergo further screening.

Official Title
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The Effect of Consumption of Almonds and Snack Mix Daily for 6 Months on Performance on a Battery of Computerized Cognitive Tests (CANTAB) in Older Adults

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Dietary Supplement: snack mix
* Dietary Supplement: almonds, 1.5 oz
* Dietary Supplement: almonds, 3 oz


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women age >50 - 75 years body mass index >25-35 kg/m2 Mini mental state exam (MMSE) score >24 must be able to give written informed consent Exclusion Criteria: history of active small bowel disease or resection atrophic gastritis uncontrolled blood pressure or untreated hypertension alcoholism (>2 drinks/d or 14 drinks/week) abnormal hematologic parameters that are determined by the study MD to influence study outcomes. endocrine disorders including diabetes or current pharmacological treatment of diabetes and untreated thyroid disease pancreatic disease anemia, and bleeding disorders nut allergy major chronic illness that might interfere with the study outcomes active cancer except for prostate cancer or cancer-free for at least 5 years unwilling to not use lutein, n3 fatty acid, or choline supplements for 2 months prior to study start diseases that interfere with fat absorption, e.g. colitis, celiac disease, Crohn's disease, cystic fibrosis (as determined by screening interview) rheumatologic diseases including gout or inflammatory arthritis immune deficiency conditions including autoimmune dieases, human immune deficiency virus (HIV); history of organ transplantation medications that interfere with fat absorption, e.g. bile sequestrants (as determined by screening interview) use of antipsychotic, antimanic, anti-inflammatory (except for aspirin and non steroidal anti-inflammatory drugs[NSAIDS]), monoamine inhibitors, or dementia medications inability to discontinue aspirin, NSAIDS for 72 hours prior to and for the duration of testing at study visits (baseline, 3 and 6 months) daily intake of proton pump inhibitors or H2 blockers smoking or use of nicotine patches or gum (within past 6 months) use of drugs suspected of interfering with metabolism of blood clotting with the exception of aspirin and NSAIDS, e.g. warfarin (as determined by screening interview) stroke, head injury with loss of consciousness or seizures. history or clinical manifestation of any significant neurologic disorder in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: snack mix<br>snack mix, 3 ounces: dried coconut, meat jerky, butter, cereal party mix | Dietary Supplement: snack mix<br>* commercial cereal mix with bits of beef jerky and coconut<br>|
| Active Comparator: almonds, 1.5 ounces<br>almonds, 1.5 ounces/day | Dietary Supplement: almonds, 1.5 oz<br>* almonds, 1.5 oz/day<br>|
| Active Comparator: almonds, 3 ounces<br>almonds, 3 ounces/day | Dietary Supplement: almonds, 3 oz<br>* almonds, 3.0 oz/day<br>* Other names: almonds, 3.0 oz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| executive function executive function assessed by test administered via CANTAB (www.cambridgecognition.com) | tests administered via CANTAB (www.cambridgecognition.com) | change from baseline executive function at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| attention assessed by test administered via CANTAB (www.cambridgecognition.com) | test administered via CANTAB (www.cambridgecognition.com) | change from baseline attention at 6 months | 
| visual memory assessed by test administered via CANTAB (www.cambridgecognition.com) | test administered via CANTAB (www.cambridgecognition.com) | change from baseline visual memory at 6 months | 
| inflammation - serum C-reactive protein as measured by ELISA kit | serum C-reactive protein - ELISA kit | change from baseline serum CRP concentration at 6 months | 
| inflammation - serum IL6 as measured by ELISA kit | serum IL-6 - ELISA kit | change from baseline serum IL-6 concentration at 6 months | 
| inflammation - serum IL12 as measured by ELISA kit | serum IL12 - ELISA kit | change from baseline serum IL-12 concentration at 6 months | 
| inflammation - serum ICAM as measured by ELISA kit | serum ICAM - ELISA kit | change from baseline serum ICAM concentration at 6 months | 
| plasma fatty acids | measured by gas chromatography | change from baseline plasma fatty acids concentration at 6 months | 
| plasma alpha-tocopherol | measured by high pressure liquid chromatography | change from baseline plasma alpha-tocopherol concentration at 6 months | 
| plasma magnesium | measured by atomic emission spectroscopy | change from baseline plasma magnesium concentration at 6 months | 
| fatty acids in red blood cells | measured by gas chromatography/mass spectroscopy | change from baseline fatty acids concentration in red blood cells at 6 months | 
| oxidative stress - aminothiols | serum aminothiols - HPLC | change from baseline serum aminothiols at 6 months | 
| oxidative stress - isoprostanes | urinary isoprostanes - spectrophotometer | change from baseline urinary isoprostanes at 6 months | 
| oxidative stress - superoxide dismutase | serum superoxide dismutase - ELISA kit | change from baseline serum superoxide dismutase at 6 months | 
| oxidative stress - glutathione peroxidase | serum glutathione peroxidase - ELISA kit | change from baseline serum glutathione peroxidase at 6 months | 
| oxidative stress - glutathione reductase | serum glutathione reductase - ELISA kti | change from baseline serum glutathione reductase at 6 months | 
| total serum cholesterol | colormetric assay Beckman Coulter AU400 | change from baseline total serum cholesterol at 6 months | 
| serum low density lipoprotein | colormetric assay Beckman Coulter AU400 | change from baseline serum low density lipoprotein at 6 months | 
| serum high density lipoprotein | colormetric assay Beckman Coulter AU400 | change from baseline serum high density lipoprotein at 6 months | 
| serum very low density lipoprotein | colormetric assay Beckman Coulter AU400 | change from baseline serum very low density lipoprotein at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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almonds, cereal snack