The Effect of Consumption of Almonds and Snack Mix Daily for 6 Months on Cognitive Function in Older Adults
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About
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.
Full 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.
Enrollment
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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