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

NCT03093896 | Completed

• 1 other identifier: 003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

almonds; cereal snack

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• attention assessed by 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)

  change from baseline visual memory at 6 months

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

  change from baseline serum CRP concentration at 6 months

• inflammation - serum IL6 as measured by ELISA kit

  change from baseline serum IL-6 concentration at 6 months

• inflammation - serum IL12 as measured by ELISA kit

  change from baseline serum IL-12 concentration at 6 months

Study Arms (3)

snack mix

PLACEBO COMPARATOR

snack mix, 3 ounces: dried coconut, meat jerky, butter, cereal party mix

Dietary Supplement: snack mix

almonds, 1.5 ounces

ACTIVE COMPARATOR

almonds, 1.5 ounces/day

Dietary Supplement: almonds, 1.5 oz

almonds, 3 ounces

ACTIVE COMPARATOR

almonds, 3 ounces/day

Dietary Supplement: almonds, 3 oz

Interventions

snack mix DIETARY_SUPPLEMENT

commercial cereal mix with bits of beef jerky and coconut

snack mix

almonds, 1.5 oz DIETARY_SUPPLEMENT

almonds, 1.5 oz/day

almonds, 1.5 ounces

almonds, 3 oz DIETARY_SUPPLEMENT

almonds, 3.0 oz/day

Also known as: almonds, 3.0 oz

almonds, 3 ounces

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• 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.

  PMID: 33448906 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Elizabeth J Johnson, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist I/Associate Professor

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: March 28, 2017
• Study Start: April 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: May 1, 2019
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)