Clinical trial NCT03093896: The Effect of Consumption of Almonds and Snack Mix Daily for 6 Months on Cognitive Function in Older Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: almonds
cereal snack
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* 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.

Primary outcomes:
measure: executive function executive function assessed by test administered via CANTAB (www.cambridgecognition.com)
timeFrame: change from baseline executive function at 6 months
Secondary outcomes:
measure: attention assessed by test administered via CANTAB (www.cambridgecognition.com)
timeFrame: change from baseline attention at 6 months
measure: visual memory assessed by test administered via CANTAB (www.cambridgecognition.com)
timeFrame: change from baseline visual memory at 6 months
measure: inflammation - serum C-reactive protein as measured by ELISA kit
timeFrame: change from baseline serum CRP concentration at 6 months
measure: inflammation - serum IL6 as measured by ELISA kit
timeFrame: change from baseline serum IL-6 concentration at 6 months
measure: inflammation - serum IL12 as measured by ELISA kit
timeFrame: change from baseline serum IL-12 concentration at 6 months
measure: inflammation - serum ICAM as measured by ELISA kit
timeFrame: change from baseline serum ICAM concentration at 6 months
measure: plasma fatty acids
timeFrame: change from baseline plasma fatty acids concentration at 6 months
measure: plasma alpha-tocopherol
timeFrame: change from baseline plasma alpha-tocopherol concentration at 6 months
measure: plasma magnesium
timeFrame: change from baseline plasma magnesium concentration at 6 months
measure: fatty acids in red blood cells
timeFrame: change from baseline fatty acids concentration in red blood cells at 6 months
measure: oxidative stress - aminothiols
timeFrame: change from baseline serum aminothiols at 6 months
measure: oxidative stress - isoprostanes
timeFrame: change from baseline urinary isoprostanes at 6 months
measure: oxidative stress - superoxide dismutase
timeFrame: change from baseline serum superoxide dismutase at 6 months
measure: oxidative stress - glutathione peroxidase
timeFrame: change from baseline serum glutathione peroxidase at 6 months
measure: oxidative stress - glutathione reductase
timeFrame: change from baseline serum glutathione reductase at 6 months
measure: total serum cholesterol
timeFrame: change from baseline total serum cholesterol at 6 months
measure: serum low density lipoprotein
timeFrame: change from baseline serum low density lipoprotein at 6 months
measure: serum high density lipoprotein
timeFrame: change from baseline serum high density lipoprotein at 6 months
measure: serum very low density lipoprotein
timeFrame: change from baseline serum very low density lipoprotein at 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Elizabeth J Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mustra Rakic J, Tanprasertsuk J, Scott TM, Rasmussen HM, Mohn ES, Chen CO, Johnson EJ. Effects of daily almond consumption for six months on cognitive measures in healthy middle-aged to older adults: a randomized control trial. Nutr Neurosci. 2022 Jul;25(7):1466-1476. doi: 10.1080/1028415X.2020.1868805. Epub 2021 Jan 15.