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Mild Cognitive ImpairmentNCT03093896

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

A study testing snack mix, almonds, 1.5 oz and almonds, 3 oz in people with Mild Cognitive Impairment, run by Tufts University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
snack mix, almonds, 1.5 oz and almonds, 3 oz
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
Apr 2016to May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Boston, Massachusetts, 02111

Other trials in United States

About this study

Official 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

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.

Read the 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.

Being tested
snack mix, almonds, 1.5 oz, almonds, 3 oz
Keywords
almonds, cereal snack
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • snack mixDietary supplement

    commercial cereal mix with bits of beef jerky and coconut

  • almonds, 1.5 ozDietary supplement

    almonds, 1.5 oz/day

  • almonds, 3 ozDietary supplement

    Also called almonds, 3.0 oz

    almonds, 3.0 oz/day

Study groups in NCT03093896
Study groupRoleWhat they receive
snack mixPlacebo comparatorsnack mix, 3 ounces: dried coconut, meat jerky, butter, cereal party mix
Receives: Dietary Supplement: snack mix
almonds, 1.5 ouncesActive comparatoralmonds, 1.5 ounces/day
Receives: Dietary Supplement: almonds, 1.5 oz
almonds, 3 ouncesActive comparatoralmonds, 3 ounces/day
Receives: Dietary Supplement: almonds, 3 oz

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    tests administered via CANTAB (www.cambridgecognition.com)

    Measured: change from baseline executive function at 6 months

Secondary outcomes (19)

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

    test administered via CANTAB (www.cambridgecognition.com)

    Measured: change from baseline attention at 6 months

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

    test administered via CANTAB (www.cambridgecognition.com)

    Measured: change from baseline visual memory at 6 months

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

    serum C-reactive protein - ELISA kit

    Measured: change from baseline serum CRP concentration at 6 months

  4. inflammation - serum IL6 as measured by ELISA kit

    serum IL-6 - ELISA kit

    Measured: change from baseline serum IL-6 concentration at 6 months

  5. inflammation - serum IL12 as measured by ELISA kit

    serum IL12 - ELISA kit

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

  6. inflammation - serum ICAM as measured by ELISA kit

    serum ICAM - ELISA kit

    Measured: change from baseline serum ICAM concentration at 6 months

  7. plasma fatty acids

    measured by gas chromatography

    Measured: change from baseline plasma fatty acids concentration at 6 months

  8. plasma alpha-tocopherol

    measured by high pressure liquid chromatography

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

  9. plasma magnesium

    measured by atomic emission spectroscopy

    Measured: change from baseline plasma magnesium concentration at 6 months

  10. fatty acids in red blood cells

    measured by gas chromatography/mass spectroscopy

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

  11. oxidative stress - aminothiols

    serum aminothiols - HPLC

    Measured: change from baseline serum aminothiols at 6 months

  12. oxidative stress - isoprostanes

    urinary isoprostanes - spectrophotometer

    Measured: change from baseline urinary isoprostanes at 6 months

  13. oxidative stress - superoxide dismutase

    serum superoxide dismutase - ELISA kit

    Measured: change from baseline serum superoxide dismutase at 6 months

  14. oxidative stress - glutathione peroxidase

    serum glutathione peroxidase - ELISA kit

    Measured: change from baseline serum glutathione peroxidase at 6 months

  15. oxidative stress - glutathione reductase

    serum glutathione reductase - ELISA kti

    Measured: change from baseline serum glutathione reductase at 6 months

  16. total serum cholesterol

    colormetric assay Beckman Coulter AU400

    Measured: change from baseline total serum cholesterol at 6 months

  17. serum low density lipoprotein

    colormetric assay Beckman Coulter AU400

    Measured: change from baseline serum low density lipoprotein at 6 months

  18. serum high density lipoprotein

    colormetric assay Beckman Coulter AU400

    Measured: change from baseline serum high density lipoprotein at 6 months

  19. serum very low density lipoprotein

    colormetric assay Beckman Coulter AU400

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2017
  2. Study startApr 2016
  3. Primary completionSep 2018
  4. Study completionMay 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03093896
Sponsor's protocol ID
003
Status last verified
Mar 2020
First submitted
25 Aug 2015
Last updated
20 Mar 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

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.

    PubMed 33448906

Questions about this trial

What is this clinical trial studying?

A study testing snack mix, almonds, 1.5 oz and almonds, 3 oz in people with Mild Cognitive Impairment, run by Tufts University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

executive function executive function assessed by test administered via CANTAB (www.cambridgecognition.com) (time frame: change from baseline executive function at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03093896, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.

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