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

Tufts University60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Mild Cognitive Impairment

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

executive function executive function assessed by test administered via CANTAB (www.cambridgecognition.com)

tests administered via CANTAB (www.cambridgecognition.com)

Time frame: change from baseline executive function at 6 months

Secondary Outcomes

attention assessed by test administered via CANTAB (www.cambridgecognition.com)

test administered via CANTAB (www.cambridgecognition.com)

Time frame: 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)

Time frame: change from baseline visual memory at 6 months

inflammation - serum C-reactive protein as measured by ELISA kit

serum C-reactive protein - ELISA kit

Time frame: change from baseline serum CRP concentration at 6 months

inflammation - serum IL6 as measured by ELISA kit

serum IL-6 - ELISA kit

Time frame: change from baseline serum IL-6 concentration at 6 months

inflammation - serum IL12 as measured by ELISA kit

serum IL12 - ELISA kit

Time frame: change from baseline serum IL-12 concentration at 6 months

inflammation - serum ICAM as measured by ELISA kit

serum ICAM - ELISA kit

Time frame: change from baseline serum ICAM concentration at 6 months

plasma fatty acids

measured by gas chromatography

Time frame: change from baseline plasma fatty acids concentration at 6 months

plasma alpha-tocopherol

measured by high pressure liquid chromatography

Time frame: change from baseline plasma alpha-tocopherol concentration at 6 months

plasma magnesium

measured by atomic emission spectroscopy

Time frame: change from baseline plasma magnesium concentration at 6 months

fatty acids in red blood cells

measured by gas chromatography/mass spectroscopy

Time frame: change from baseline fatty acids concentration in red blood cells at 6 months

oxidative stress - aminothiols

serum aminothiols - HPLC

Time frame: change from baseline serum aminothiols at 6 months

oxidative stress - isoprostanes

urinary isoprostanes - spectrophotometer

Time frame: change from baseline urinary isoprostanes at 6 months

oxidative stress - superoxide dismutase

serum superoxide dismutase - ELISA kit

Time frame: change from baseline serum superoxide dismutase at 6 months

oxidative stress - glutathione peroxidase

serum glutathione peroxidase - ELISA kit

Time frame: change from baseline serum glutathione peroxidase at 6 months

oxidative stress - glutathione reductase

serum glutathione reductase - ELISA kti

Time frame: change from baseline serum glutathione reductase at 6 months

total serum cholesterol

colormetric assay Beckman Coulter AU400

Time frame: change from baseline total serum cholesterol at 6 months

serum low density lipoprotein

colormetric assay Beckman Coulter AU400

Time frame: change from baseline serum low density lipoprotein at 6 months

serum high density lipoprotein

colormetric assay Beckman Coulter AU400

Time frame: change from baseline serum high density lipoprotein at 6 months

serum very low density lipoprotein

colormetric assay Beckman Coulter AU400

Time frame: change from baseline serum very low density lipoprotein at 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes