NCT01621646

Brief Summary

Cognitive impairment is also a major risk factor for development of dementia later in life. Findings from our studies suggest that the carotenoids, lutein and zeaxanthin may be important in cognitive function in the elderly. The investigators have previously reported eggs to be a highly bioavailable source of lutein and zeaxanthin. Our study evaluates long-term egg 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. Our studies have shown that egg interventions can significantly increase serum lutein concentrations in older adults. Based on the sum of our findings, the next logical step will be to investigate the ability of lutein and zeaxanthin contained in eggs 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 2 egg/day at the end of 6 months, while no significant improvements will be observed in older adults given daily meals containing egg substitute. The proposed study is designed as a randomized, placebo controlled trial that tests the effects of 6 month supplementation with 2 eggs/day on cognitive function in older adults. Secondary analyses will determine whether baseline MP density predicts relative effectiveness of the intervention on cognitive function. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

3.1 years

First QC Date

March 13, 2012

Last Update Submit

August 31, 2017

Conditions

Mild Cognitive Impairment

Keywords

luteineggsmild cognitive impairmentelderly

Outcome Measures

Primary Outcomes (1)

  • cognition

    measures of attention, executive function, verbal fluency will be made using a sensitive computerized program

    6 months

Secondary Outcomes (1)

  • inflammation

    6 months

Study Arms (2)

egg white (control)

PLACEBO COMPARATOR

egg whites, 4 ounces per day for six months

Other: eggs or egg whites

eggs

EXPERIMENTAL

eggs, 2 large per day for 6 months

Other: eggs or egg whites

Interventions

eggs or egg whitesOTHER

2 eggs/day or 4 oz egg whites/day for 6 months

egg white (control)eggs

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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
  • DHA (docosahexaehoic acid) intake \< 250 mg/d (including supplements)
  • Mini mental state exam (MMSE) score \> 24 (Appendix B)
  • macular pigment density \< 0.5 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, or choline supplements (\> 3 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Interventions

EggsEgg White

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Elizabeth J Johnson, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

June 18, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations

US(1)