Mild Cognitive Impairment Clinical Trial
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
NCT number | NCT03093896 |
Other study ID # | 003 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | May 2019 |
Verified date | March 2020 |
Source | Tufts University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2019 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tufts University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | attention assessed by test administered via CANTAB (www.cambridgecognition.com) | test administered via CANTAB (www.cambridgecognition.com) | change from baseline attention at 6 months | |
Secondary | visual memory assessed by test administered via CANTAB (www.cambridgecognition.com) | test administered via CANTAB (www.cambridgecognition.com) | change from baseline visual memory at 6 months | |
Secondary | inflammation - serum C-reactive protein as measured by ELISA kit | serum C-reactive protein - ELISA kit | change from baseline serum CRP concentration at 6 months | |
Secondary | inflammation - serum IL6 as measured by ELISA kit | serum IL-6 - ELISA kit | change from baseline serum IL-6 concentration at 6 months | |
Secondary | inflammation - serum IL12 as measured by ELISA kit | serum IL12 - ELISA kit | change from baseline serum IL-12 concentration at 6 months | |
Secondary | inflammation - serum ICAM as measured by ELISA kit | serum ICAM - ELISA kit | change from baseline serum ICAM concentration at 6 months | |
Secondary | plasma fatty acids | measured by gas chromatography | change from baseline plasma fatty acids concentration at 6 months | |
Secondary | plasma alpha-tocopherol | measured by high pressure liquid chromatography | change from baseline plasma alpha-tocopherol concentration at 6 months | |
Secondary | plasma magnesium | measured by atomic emission spectroscopy | change from baseline plasma magnesium concentration at 6 months | |
Secondary | fatty acids in red blood cells | measured by gas chromatography/mass spectroscopy | change from baseline fatty acids concentration in red blood cells at 6 months | |
Secondary | oxidative stress - aminothiols | serum aminothiols - HPLC | change from baseline serum aminothiols at 6 months | |
Secondary | oxidative stress - isoprostanes | urinary isoprostanes - spectrophotometer | change from baseline urinary isoprostanes at 6 months | |
Secondary | oxidative stress - superoxide dismutase | serum superoxide dismutase - ELISA kit | change from baseline serum superoxide dismutase at 6 months | |
Secondary | oxidative stress - glutathione peroxidase | serum glutathione peroxidase - ELISA kit | change from baseline serum glutathione peroxidase at 6 months | |
Secondary | oxidative stress - glutathione reductase | serum glutathione reductase - ELISA kti | change from baseline serum glutathione reductase at 6 months | |
Secondary | total serum cholesterol | colormetric assay Beckman Coulter AU400 | change from baseline total serum cholesterol at 6 months | |
Secondary | serum low density lipoprotein | colormetric assay Beckman Coulter AU400 | change from baseline serum low density lipoprotein at 6 months | |
Secondary | serum high density lipoprotein | colormetric assay Beckman Coulter AU400 | change from baseline serum high density lipoprotein at 6 months | |
Secondary | serum very low density lipoprotein | colormetric assay Beckman Coulter AU400 | change from baseline serum very low density lipoprotein at 6 months |
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