Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111, United States
NCT Number: NCT03093896
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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Notify Me50 year–75 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02111, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
commercial cereal mix with bits of beef jerky and coconut
almonds, 1.5 oz/day
almonds, 3.0 oz/day
Other names: almonds, 3.0 oz
Time frame: change from baseline executive function at 6 months
tests administered via CANTAB (www.cambridgecognition.com)
Time frame: change from baseline attention at 6 months
test administered via CANTAB (www.cambridgecognition.com)
Time frame: change from baseline visual memory at 6 months
test administered via CANTAB (www.cambridgecognition.com)
Time frame: change from baseline serum CRP concentration at 6 months
serum C-reactive protein - ELISA kit
Time frame: change from baseline serum IL-6 concentration at 6 months
serum IL-6 - ELISA kit
Time frame: change from baseline serum IL-12 concentration at 6 months
serum IL12 - ELISA kit
Time frame: change from baseline serum ICAM concentration at 6 months
serum ICAM - ELISA kit
Time frame: change from baseline plasma fatty acids concentration at 6 months
measured by gas chromatography
Time frame: change from baseline plasma alpha-tocopherol concentration at 6 months
measured by high pressure liquid chromatography
Time frame: change from baseline plasma magnesium concentration at 6 months
measured by atomic emission spectroscopy
Time frame: change from baseline fatty acids concentration in red blood cells at 6 months
measured by gas chromatography/mass spectroscopy
Time frame: change from baseline serum aminothiols at 6 months
serum aminothiols - HPLC
Time frame: change from baseline urinary isoprostanes at 6 months
urinary isoprostanes - spectrophotometer
Time frame: change from baseline serum superoxide dismutase at 6 months
serum superoxide dismutase - ELISA kit
Time frame: change from baseline serum glutathione peroxidase at 6 months
serum glutathione peroxidase - ELISA kit
Time frame: change from baseline serum glutathione reductase at 6 months
serum glutathione reductase - ELISA kti
Time frame: change from baseline total serum cholesterol at 6 months
colormetric assay Beckman Coulter AU400
Time frame: change from baseline serum low density lipoprotein at 6 months
colormetric assay Beckman Coulter AU400
Time frame: change from baseline serum high density lipoprotein at 6 months
colormetric assay Beckman Coulter AU400
Time frame: change from baseline serum very low density lipoprotein at 6 months
colormetric assay Beckman Coulter AU400
Tufts University
Other
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
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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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