Back to resultsThe Effect of Consumption of Almonds and Snack Mix Daily for 6 Months on Cognitive Function in Older Adults
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
snack mix
almonds, 1.5 oz
almonds, 3 oz
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring almonds, cereal snack
Eligibility Criteria
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.
Sites / Locations
- Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
snack mix
almonds, 1.5 ounces
almonds, 3 ounces
Arm Description
snack mix, 3 ounces: dried coconut, meat jerky, butter, cereal party mix
almonds, 1.5 ounces/day
almonds, 3 ounces/day
Outcomes
Primary Outcome Measures
executive function executive function assessed by test administered via CANTAB (www.cambridgecognition.com)
tests administered via CANTAB (www.cambridgecognition.com)
Secondary Outcome Measures
attention assessed by test administered via CANTAB (www.cambridgecognition.com)
test administered via CANTAB (www.cambridgecognition.com)
visual memory assessed by test administered via CANTAB (www.cambridgecognition.com)
test administered via CANTAB (www.cambridgecognition.com)
inflammation - serum C-reactive protein as measured by ELISA kit
serum C-reactive protein - ELISA kit
inflammation - serum IL6 as measured by ELISA kit
serum IL-6 - ELISA kit
inflammation - serum IL12 as measured by ELISA kit
serum IL12 - ELISA kit
inflammation - serum ICAM as measured by ELISA kit
serum ICAM - ELISA kit
plasma fatty acids
measured by gas chromatography
plasma alpha-tocopherol
measured by high pressure liquid chromatography
plasma magnesium
measured by atomic emission spectroscopy
fatty acids in red blood cells
measured by gas chromatography/mass spectroscopy
oxidative stress - aminothiols
serum aminothiols - HPLC
oxidative stress - isoprostanes
urinary isoprostanes - spectrophotometer
oxidative stress - superoxide dismutase
serum superoxide dismutase - ELISA kit
oxidative stress - glutathione peroxidase
serum glutathione peroxidase - ELISA kit
oxidative stress - glutathione reductase
serum glutathione reductase - ELISA kti
total serum cholesterol
colormetric assay Beckman Coulter AU400
serum low density lipoprotein
colormetric assay Beckman Coulter AU400
serum high density lipoprotein
colormetric assay Beckman Coulter AU400
serum very low density lipoprotein
colormetric assay Beckman Coulter AU400
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03093896
Brief Title
The Effect of Consumption of Almonds and Snack Mix Daily for 6 Months on Cognitive Function in Older Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
almonds, cereal snack
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
snack mix
Arm Type
Placebo Comparator
Arm Description
snack mix, 3 ounces: dried coconut, meat jerky, butter, cereal party mix
Arm Title
almonds, 1.5 ounces
Arm Type
Active Comparator
Arm Description
almonds, 1.5 ounces/day
Arm Title
almonds, 3 ounces
Arm Type
Active Comparator
Arm Description
almonds, 3 ounces/day
Intervention Type
Dietary Supplement
Intervention Name(s)
snack mix
Intervention Description
commercial cereal mix with bits of beef jerky and coconut
Intervention Type
Dietary Supplement
Intervention Name(s)
almonds, 1.5 oz
Intervention Description
almonds, 1.5 oz/day
Intervention Type
Dietary Supplement
Intervention Name(s)
almonds, 3 oz
Other Intervention Name(s)
almonds, 3.0 oz
Intervention Description
almonds, 3.0 oz/day
Primary Outcome Measure Information:
Title
executive function executive function assessed by test administered via CANTAB (www.cambridgecognition.com)
Description
tests administered via CANTAB (www.cambridgecognition.com)
Time Frame
change from baseline executive function at 6 months
Secondary Outcome Measure Information:
Title
attention assessed by test administered via CANTAB (www.cambridgecognition.com)
Description
test administered via CANTAB (www.cambridgecognition.com)
Time Frame
change from baseline attention at 6 months
Title
visual memory assessed by test administered via CANTAB (www.cambridgecognition.com)
Description
test administered via CANTAB (www.cambridgecognition.com)
Time Frame
change from baseline visual memory at 6 months
Title
inflammation - serum C-reactive protein as measured by ELISA kit
Description
serum C-reactive protein - ELISA kit
Time Frame
change from baseline serum CRP concentration at 6 months
Title
inflammation - serum IL6 as measured by ELISA kit
Description
serum IL-6 - ELISA kit
Time Frame
change from baseline serum IL-6 concentration at 6 months
Title
inflammation - serum IL12 as measured by ELISA kit
Description
serum IL12 - ELISA kit
Time Frame
change from baseline serum IL-12 concentration at 6 months
Title
inflammation - serum ICAM as measured by ELISA kit
Description
serum ICAM - ELISA kit
Time Frame
change from baseline serum ICAM concentration at 6 months
Title
plasma fatty acids
Description
measured by gas chromatography
Time Frame
change from baseline plasma fatty acids concentration at 6 months
Title
plasma alpha-tocopherol
Description
measured by high pressure liquid chromatography
Time Frame
change from baseline plasma alpha-tocopherol concentration at 6 months
Title
plasma magnesium
Description
measured by atomic emission spectroscopy
Time Frame
change from baseline plasma magnesium concentration at 6 months
Title
fatty acids in red blood cells
Description
measured by gas chromatography/mass spectroscopy
Time Frame
change from baseline fatty acids concentration in red blood cells at 6 months
Title
oxidative stress - aminothiols
Description
serum aminothiols - HPLC
Time Frame
change from baseline serum aminothiols at 6 months
Title
oxidative stress - isoprostanes
Description
urinary isoprostanes - spectrophotometer
Time Frame
change from baseline urinary isoprostanes at 6 months
Title
oxidative stress - superoxide dismutase
Description
serum superoxide dismutase - ELISA kit
Time Frame
change from baseline serum superoxide dismutase at 6 months
Title
oxidative stress - glutathione peroxidase
Description
serum glutathione peroxidase - ELISA kit
Time Frame
change from baseline serum glutathione peroxidase at 6 months
Title
oxidative stress - glutathione reductase
Description
serum glutathione reductase - ELISA kti
Time Frame
change from baseline serum glutathione reductase at 6 months
Title
total serum cholesterol
Description
colormetric assay Beckman Coulter AU400
Time Frame
change from baseline total serum cholesterol at 6 months
Title
serum low density lipoprotein
Description
colormetric assay Beckman Coulter AU400
Time Frame
change from baseline serum low density lipoprotein at 6 months
Title
serum high density lipoprotein
Description
colormetric assay Beckman Coulter AU400
Time Frame
change from baseline serum high density lipoprotein at 6 months
Title
serum very low density lipoprotein
Description
colormetric assay Beckman Coulter AU400
Time Frame
change from baseline serum very low density lipoprotein at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth J Johnson, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
33448906
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Consumption of Almonds and Snack Mix Daily for 6 Months on Cognitive Function in Older Adults
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