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

Primary Purpose

Mild Cognitive Impairment

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

avocado

potato or chickpea

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring lutein, avocados, chickpeas, potatoes, elderly

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

chickpeas/potatoes

avocados

Arm Description

1 potato/day or 1 cup chickpeas

1 avocados/day

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Inflammation

C-reactive protein

Inflammation

C-reactive protein

Inflammation

C-reactive protein

Full Information

NCT ID

NCT01620567

First Posted

June 13, 2012

Last Updated

May 8, 2019

Sponsor

Tufts University

1. Study Identification

Unique Protocol Identification Number

NCT01620567

Brief Title

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

Official Title

The Effect of Consumption of Potatoes, Avocados and Chickpeas Daily for 6 Months on Cognitive Function in Older Adults

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tufts University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

lutein, avocados, chickpeas, potatoes, elderly

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

chickpeas/potatoes

Arm Type

Placebo Comparator

Arm Description

1 potato/day or 1 cup chickpeas

Arm Title

avocados

Arm Type

Active Comparator

Arm Description

1 avocados/day

Intervention Type

Other

Intervention Name(s)

avocado

Intervention Description

1 avocado/day for 6 months

Intervention Type

Other

Intervention Name(s)

potato or chickpea

Intervention Description

1 cup potatoes or chickpeas/day for 6 months

Primary Outcome Measure Information:

Title

Cognition

Description

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).

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Inflammation

Description

C-reactive protein

Time Frame

0 months

Title

Inflammation

Description

C-reactive protein

Time Frame

3 month

Title

Inflammation

Description

C-reactive protein

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth J Johnson, Ph.D.

Organizational Affiliation

Tufts University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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