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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tufts University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- executive function executive function assessed by test administered via CANTAB (www.cambridgecognition.com)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
snack mix
snack mix, 3 ounces: dried coconut, meat jerky, butter, cereal party mix
Intervention: snack mix (Dietary Supplement)
almonds, 1.5 ounces
almonds, 1.5 ounces/day
Intervention: almonds, 1.5 oz (Dietary Supplement)
almonds, 3 ounces
almonds, 3 ounces/day
Intervention: almonds, 3 oz (Dietary Supplement)
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 - 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)
- 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 - isoprostanes(change from baseline urinary isoprostanes 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)
Investigators
Elizabeth Johnson
Scientist I/Associate Professor
Tufts University