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Consumption of Potatoes, Avocados and Chickpeas and Cognitive Function in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01620567
Recruitment Status : Completed
First Posted : June 15, 2012
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Tufts University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Other: avocado Other: potato or chickpea Not Applicable

Detailed Description:
The study is designed as a placebo controlled trial that tests the effects of 6 month supplementation with daily meals containing 1 avocado or isocaloric amounts of chickpeas and/or potatoes on cognitive function in older adults. Subjects will be randomly assigned to one of the two groups. Secondary analyses will determine whether baseline macular pigment density (a non invasive measure of lutein and zeaxanthin in neural tissue) predicts relative effectiveness of the intervention on cognitive function. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation. Participants will be recruited from community-dwelling men and women aged >50 yr, 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. The study will include baseline (0 month), 3 and 6 month visits for study procedures, and monthly telephone calls. Given that there is a visible difference between the two interventions, a blinded study is not possible.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Consumption of Potatoes, Avocados and Chickpeas Daily for 6 Months on Cognitive Function in Older Adults
Study Start Date : August 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Placebo Comparator: chickpeas/potatoes
1 potato/day or 1 cup chickpeas
Other: potato or chickpea
1 cup potatoes or chickpeas/day for 6 months

Active Comparator: avocados
1 avocados/day
Other: avocado
1 avocado/day for 6 months




Primary Outcome Measures :
  1. Cognition [ Time Frame: 6 months ]
    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).


Secondary Outcome Measures :
  1. Inflammation [ Time Frame: 0 months ]
    C-reactive protein

  2. Inflammation [ Time Frame: 3 month ]
    C-reactive protein

  3. Inflammation [ Time Frame: 6 month ]
    C-reactive protein



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620567


Locations
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United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Investigators
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Principal Investigator: Elizabeth J Johnson, Ph.D. Tufts University

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Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01620567    
Other Study ID Numbers: 002
First Posted: June 15, 2012    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tufts University:
lutein
avocados
chickpeas
potatoes
elderly
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders