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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Dietary Supplement: almonds, 3 oz; Dietary Supplement: almonds, 1.5 oz; Dietary Supplement: snack mix

• Registration Number: NCT03093896
• Lead Sponsor: Tufts University

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 Timeline

• Study First Submitted: 2015-08-25
• Study Start: 2016-04
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-28
• Primary Completion: 2018-09
• Study Completion: 2019-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
almonds, 3 ounces	almonds, 3 oz	almonds, 3 ounces/day
almonds, 1.5 ounces	almonds, 1.5 oz	almonds, 1.5 ounces/day
snack mix	snack mix	snack mix, 3 ounces: dried coconut, meat jerky, butter, cereal party mix

Primary Outcome Measures

Name	Time	Method
executive function executive function assessed by test administered via CANTAB (www.cambridgecognition.com)	change from baseline executive function at 6 months	tests administered via CANTAB (www.cambridgecognition.com)

Secondary Outcome Measures

Name	Time	Method
attention assessed by test administered via CANTAB (www.cambridgecognition.com)	change from baseline attention at 6 months	test administered via CANTAB (www.cambridgecognition.com)
visual memory assessed by test administered via CANTAB (www.cambridgecognition.com)	change from baseline visual memory at 6 months	test administered via CANTAB (www.cambridgecognition.com)
inflammation - serum C-reactive protein as measured by ELISA kit	change from baseline serum CRP concentration at 6 months	serum C-reactive protein - ELISA kit
inflammation - serum IL6 as measured by ELISA kit	change from baseline serum IL-6 concentration at 6 months	serum IL-6 - ELISA kit
inflammation - serum IL12 as measured by ELISA kit	change from baseline serum IL-12 concentration at 6 months	serum IL12 - ELISA kit
inflammation - serum ICAM as measured by ELISA kit	change from baseline serum ICAM concentration at 6 months	serum ICAM - ELISA kit
plasma fatty acids	change from baseline plasma fatty acids concentration at 6 months	measured by gas chromatography
plasma magnesium	change from baseline plasma magnesium concentration at 6 months	measured by atomic emission spectroscopy
fatty acids in red blood cells	change from baseline fatty acids concentration in red blood cells at 6 months	measured by gas chromatography/mass spectroscopy
oxidative stress - aminothiols	change from baseline serum aminothiols at 6 months	serum aminothiols - HPLC
oxidative stress - isoprostanes	change from baseline urinary isoprostanes at 6 months	urinary isoprostanes - spectrophotometer
oxidative stress - superoxide dismutase	change from baseline serum superoxide dismutase at 6 months	serum superoxide dismutase - ELISA kit
plasma alpha-tocopherol	change from baseline plasma alpha-tocopherol concentration at 6 months	measured by high pressure liquid chromatography
oxidative stress - glutathione peroxidase	change from baseline serum glutathione peroxidase at 6 months	serum glutathione peroxidase - ELISA kit
oxidative stress - glutathione reductase	change from baseline serum glutathione reductase at 6 months	serum glutathione reductase - ELISA kti
total serum cholesterol	change from baseline total serum cholesterol at 6 months	colormetric assay Beckman Coulter AU400
serum low density lipoprotein	change from baseline serum low density lipoprotein at 6 months	colormetric assay Beckman Coulter AU400
serum high density lipoprotein	change from baseline serum high density lipoprotein at 6 months	colormetric assay Beckman Coulter AU400
serum very low density lipoprotein	change from baseline serum very low density lipoprotein at 6 months	colormetric assay Beckman Coulter AU400

Trial Locations

Locations (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University; 🇺🇸 Boston, Massachusetts, United States