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

NCT01620567 | Completed Results

• 1 other identifier: 002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

lutein; avocados; chickpeas; potatoes; elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Inflammation

  0 months

• Inflammation

  3 month

• Inflammation

  6 month

Study Arms (2)

chickpeas/potatoes

PLACEBO COMPARATOR

1 potato/day or 1 cup chickpeas

Other: potato or chickpea

avocados

ACTIVE COMPARATOR

1 avocados/day

Other: avocado

Interventions

avocado OTHER

1 avocado/day for 6 months

avocados

potato or chickpea OTHER

1 cup potatoes or chickpeas/day for 6 months

chickpeas/potatoes

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Elizabeth J. Johnson, PhD
• Organization: Tufts University

elizabeth.johnson@tufts.edu

617.556.3204

Study Officials

• Elizabeth J Johnson, Ph.D.

  Tufts University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 19, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)