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

Completed · Not applicable

Conditions studied: Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT03093896

Run by

Tufts University

People needed

60

Starts

2016-04-01

Expected to finish

2019-05-01

Last updated by the study team

2020-03-20

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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)
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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