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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Tufts University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- executive function executive function assessed by test administered via CANTAB (www.cambridgecognition.com)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Elizabeth Johnson
Scientist I/Associate Professor
Tufts University
Eligibility Criteria
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
Outcomes
Primary Outcomes
executive function executive function assessed by test administered via CANTAB (www.cambridgecognition.com)
Time Frame: change from baseline executive function at 6 months
tests administered via CANTAB (www.cambridgecognition.com)
Secondary Outcomes
- oxidative stress - isoprostanes(change from baseline urinary isoprostanes at 6 months)
- attention assessed by 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)(change from baseline visual memory at 6 months)
- inflammation - serum C-reactive protein as measured by ELISA kit(change from baseline serum CRP concentration at 6 months)
- inflammation - serum IL6 as measured by ELISA kit(change from baseline serum IL-6 concentration at 6 months)
- inflammation - serum IL12 as measured by ELISA kit(change from baseline serum IL-12 concentration at 6 months)
- inflammation - serum ICAM as measured by ELISA kit(change from baseline serum ICAM concentration at 6 months)
- plasma fatty acids(change from baseline plasma fatty acids concentration at 6 months)
- plasma magnesium(change from baseline plasma magnesium concentration at 6 months)
- fatty acids in red blood cells(change from baseline fatty acids concentration in red blood cells at 6 months)
- oxidative stress - aminothiols(change from baseline serum aminothiols at 6 months)
- oxidative stress - superoxide dismutase(change from baseline serum superoxide dismutase at 6 months)
- plasma alpha-tocopherol(change from baseline plasma alpha-tocopherol concentration at 6 months)
- oxidative stress - glutathione peroxidase(change from baseline serum glutathione peroxidase at 6 months)
- oxidative stress - glutathione reductase(change from baseline serum glutathione reductase at 6 months)
- total serum cholesterol(change from baseline total serum cholesterol at 6 months)
- serum low density lipoprotein(change from baseline serum low density lipoprotein at 6 months)
- serum high density lipoprotein(change from baseline serum high density lipoprotein at 6 months)
- serum very low density lipoprotein(change from baseline serum very low density lipoprotein at 6 months)