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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093896
• Other study ID #: 003
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2019

Study information

• Verified date: March 2020
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Dietary Supplement:
• snack mix
commercial cereal mix with bits of beef jerky and coconut
• almonds, 1.5 oz
almonds, 1.5 oz/day
• almonds, 3 oz
almonds, 3.0 oz/day

Locations

Country	Name	City	State
United States	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

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