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

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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Dietary supplement: snack mix; Dietary supplement: almonds, 1.5 oz; Dietary supplement: almonds, 3 oz

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: snack mix; snack mix, 3 ounces: dried coconut, meat jerky, butter, cereal party mix	Dietary supplement: snack mix; commercial cereal mix with bits of beef jerky and coconut
Active Comparator: almonds, 1.5 ounces; almonds, 1.5 ounces/day	Dietary supplement: almonds, 1.5 oz; almonds, 1.5 oz/day
Active Comparator: almonds, 3 ounces; almonds, 3 ounces/day	Dietary supplement: almonds, 3 oz; almonds, 3.0 oz/day; Other Names: almonds, 3.0 oz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
executive function executive function assessed by test administered via CANTAB (www.cambridgecognition.com)	tests administered via CANTAB (www.cambridgecognition.com)	change from baseline executive function at 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tufts University
• Investigators: Principal Investigator: Elizabeth J Johnson, PhD, Tufts University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: August 25, 2015
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: almonds; cereal snack
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 003 (033)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES