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The Effect of Daily Consumption of Eggs on Cognitive Function in the Elderly

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eggs or egg whites
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring lutein, eggs, mild cognitive impairment, 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
  • 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).

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

Experimental

Arm Label

egg white (control)

eggs

Arm Description

egg whites, 4 ounces per day for six months

eggs, 2 large per day for 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

inflammation
markers of inflammation will be made in plasma

Full Information

First Posted
March 13, 2012
Last Updated
August 31, 2017
Sponsor
Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT01621646
Brief Title
The Effect of Daily Consumption of Eggs on Cognitive Function in the Elderly
Official Title
The Effect of Consumption of 2 Eggs or 4 oz of Egg Substitute Daily for 6 Months on Cognitive Function in Older Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study is designed as a placebo controlled trial that tests the effects of 6 month supplementation with 2 eggs or 4 ounces of egg substitute a day 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) or choline status predicts relative effectiveness of the intervention on cognitive function. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation, choline bioavailability, and genetic variants related to endogenous choline production. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
lutein, eggs, mild cognitive impairment, elderly

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
egg white (control)
Arm Type
Placebo Comparator
Arm Description
egg whites, 4 ounces per day for six months
Arm Title
eggs
Arm Type
Experimental
Arm Description
eggs, 2 large per day for 6 months
Intervention Type
Other
Intervention Name(s)
eggs or egg whites
Intervention Description
2 eggs/day or 4 oz egg whites/day for 6 months
Primary Outcome Measure Information:
Title
cognition
Description
measures of attention, executive function, verbal fluency will be made using a sensitive computerized program
Time Frame
6 months
Secondary Outcome Measure Information:
Title
inflammation
Description
markers of inflammation will be made in plasma
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth J Johnson, PhD
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

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The Effect of Daily Consumption of Eggs on Cognitive Function in the Elderly

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