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NCT Number: NCT03093896

The Effect of Consumption of Almonds and Snack Mix Daily for 6 Months on Cognitive Function 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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

snack mix

Dietary Supplement

commercial cereal mix with bits of beef jerky and coconut

almonds, 1.5 oz

Dietary Supplement

almonds, 1.5 oz/day

almonds, 3 oz

Dietary Supplement

almonds, 3.0 oz/day

Other names: almonds, 3.0 oz

Primary outcomes

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

    Time frame: change from baseline executive function at 6 months

    tests administered via CANTAB (www.cambridgecognition.com)

Secondary outcomes

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

    Time frame: change from baseline attention at 6 months

    test administered via CANTAB (www.cambridgecognition.com)

  2. visual memory assessed by test administered via CANTAB (www.cambridgecognition.com)

    Time frame: change from baseline visual memory at 6 months

    test administered via CANTAB (www.cambridgecognition.com)

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

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

    serum C-reactive protein - ELISA kit

  4. inflammation - serum IL6 as measured by ELISA kit

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

    serum IL-6 - ELISA kit

  5. inflammation - serum IL12 as measured by ELISA kit

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

    serum IL12 - ELISA kit

  6. inflammation - serum ICAM as measured by ELISA kit

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

    serum ICAM - ELISA kit

  7. plasma fatty acids

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

    measured by gas chromatography

  8. plasma alpha-tocopherol

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

    measured by high pressure liquid chromatography

  9. plasma magnesium

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

    measured by atomic emission spectroscopy

  10. fatty acids in red blood cells

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

    measured by gas chromatography/mass spectroscopy

  11. oxidative stress - aminothiols

    Time frame: change from baseline serum aminothiols at 6 months

    serum aminothiols - HPLC

  12. oxidative stress - isoprostanes

    Time frame: change from baseline urinary isoprostanes at 6 months

    urinary isoprostanes - spectrophotometer

  13. oxidative stress - superoxide dismutase

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

    serum superoxide dismutase - ELISA kit

  14. oxidative stress - glutathione peroxidase

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

    serum glutathione peroxidase - ELISA kit

  15. oxidative stress - glutathione reductase

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

    serum glutathione reductase - ELISA kti

  16. total serum cholesterol

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

    colormetric assay Beckman Coulter AU400

  17. serum low density lipoprotein

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

    colormetric assay Beckman Coulter AU400

  18. serum high density lipoprotein

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

    colormetric assay Beckman Coulter AU400

  19. serum very low density lipoprotein

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

    colormetric assay Beckman Coulter AU400

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Mar 28, 2017
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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