Mild Cognitive Impairment Clinical Trial
Official title:
The Effect of Consumption of Potatoes, Avocados and Chickpeas Daily for 6 Months on Cognitive Function in Older Adults
NCT number | NCT01620567 |
Other study ID # | 002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2012 |
Est. completion date | August 2014 |
Verified date | May 2019 |
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 the investigators studies suggest that the carotenoids, lutein and zeaxanthin
may be important in cognitive function in the elderly. Avocados are a source of these
carotenoids. The investigators study evaluates long-term avocado intervention as a treatment
strategy for age-related cognitive impairment which could possibly prevent the onset of
dementia. The investigators have also shown that lutein supplementation significantly
improved verbal fluency scores in healthy older women. Based on these findings, the next
logical step will be to investigate the ability of lutein and zeaxanthin contained in
avocados to influence cognitive function in older adults. The investigators hypothesize that
there will be a significant increase in cognitive function measures in older adults provided
with meals containing 1 avocado/day at the end of 6 months, while no significant improvements
will be observed in older adults given daily meals containing chickpeas and/or potatoes.
The proposed study is designed as a randomized, placebo controlled trial that tests the
effects of 6 month supplementation with 1 avocado/day on cognitive function in older adults.
Secondary analyses will determine whether baseline macular pigment (lutein in retina which
canbe measured non invasivley) density predicts relative effectiveness of the intervention on
cognitive function. Secondary outcomes include plasma biomarkers of oxidative stress and
inflammation.
Status | Completed |
Enrollment | 48 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - men and women age > 50 years - BMI 19-30 kg/m2 - lutein intake of < 3 mg/d - Docosahexaenoic acid intake < 250 mg/d (including supplements) - Mini mental state exam (MMSE) score > 24 - Macular pigment density < 0.4 at 0.5 degrees - Beck Depression Inventory < 20 - free of known disease - BMI 19-29 kg/m2 - must be able to give written informed consent - have normal hematologic parameters - normal values of plasma albumin - normal values for liver and kidney function (Appendix A) - no use of carotenoid, n3 fatty acid, multivitamin/mineral, (> 2 months). Exclusion Criteria: - history of active small bowel disease or resection - atrophic gastritis - hyperlipidemia (LDL >120 mg/dL or triglycerides >150 mg/dL) - hypertension (>150/90 mm Hg) - diabetes, alcoholism (>2 drinks/d or 14 drinks/week) - pancreatic disease - anemia, and bleeding disorders (as determined by screening interview) - avocado, potato or chickpea allergy - pregnancy or lactation - diseases that interfere with fat absorption, e.g. colitis, celiac disease, Crohn's disease, cystic fibroids (as determined by screening interview) - medications that interfere with fat absorption, e.g. bile sequestrants (as determined by screening interview) - use of antipsychotic, antimanic, anti-inflammatory, monoamine inhibitors, or dementia medications - smoking or use of nicotine patches or gum (within past 6 months) - use of drugs suspected of interfering with metabolism of blood clotting, e.g. warfarin (as determined by screening interview) - subjects having extremely high dietary intakes of carotenoids as indicated by screening plasma values > NHANES 95th percentile for lutein/zeaxanthin, beta-carotene, cryptoxanthin, or lycopene - stroke,head injury with loss of consciousness or seizures. - Non English speaking: This is a small study with a sample size. Logistically and financially, getting materials translated for such a small study is not feasible. |
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 | Cognition | measures of sustained attention will be made using CANTAB, a sensitive computerized program. Signal detection measured on a scale from 0 to 1(bad to good). | 6 months | |
Secondary | Inflammation | C-reactive protein | 0 months | |
Secondary | Inflammation | C-reactive protein | 3 month | |
Secondary | Inflammation | C-reactive protein | 6 month |
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