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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Tufts University
Sponsor:
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT01620567
First received: June 13, 2012
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Mild Cognitive Impairment
Dietary Supplement: avocado or chickpeas/potatoes
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Consumption of Potatoes, Avocados and Chickpeas Daily for 6 Months on Cognitive Function in Older Adults

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • cognition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measures of attention, executive function, verbal fluency will be made using a sensitive computerized program


Secondary Outcome Measures:
  • inflammation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    markers of inflammation will be made in plasma


Estimated Enrollment: 44
Study Start Date: August 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: chickpeas/potatoes Dietary Supplement: avocado or chickpeas/potatoes
1 avocado/day for 6 months or equivalent calories of chickpeas/potatoes for 6 months
Active Comparator: avocados
avocados
Dietary Supplement: avocado or chickpeas/potatoes
1 avocado/day for 6 months or equivalent calories of chickpeas/potatoes for 6 months

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 (eggs, egg substitute), a blinded study is not possible.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- men and women age > 50 years BMI 19-30 kg/m2 lutein intake of < 3 mg/d DHA intake < 250 mg/d (including supplements) Mini mental state exam (MMSE) score > 24 (Appendix B) MP 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 fibrosid (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. Future larger studies resulting from this pilot trial would consider non-English speaking participants.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620567

Contacts
Contact: Elizabeth J Johnson, Ph.D. 617 556 3204 elizabeth.johnson@tufts.edu
Contact: Rohini Vishwanathan, Ph.D. 978 837 2061 rohini.vishwanathan@tufts.edu

Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University Recruiting
Boston, Massachusetts, United States, 02111
Contact: Elizabeth J Johnson, Ph.D.    617-556-3204      
Contact: Rohini Vishwanathan, Ph.D.    978 837 2061    rohini.vishwanathan@tufts.edu   
Sponsors and Collaborators
Tufts University
  More Information

No publications provided

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01620567     History of Changes
Other Study ID Numbers: 002
Study First Received: June 13, 2012
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
lutein
avocados
chickpeas
potatoes
elderly

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014