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

Mild Cognitive Impairment Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621646
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: March 13, 2012
• Last updated: August 31, 2017
• Start date: July 2012
• Est. completion date: August 2015

Study information

• Verified date: August 2017
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
United States	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognition	measures of attention, executive function, verbal fluency will be made using a sensitive computerized program	6 months
Secondary	inflammation	markers of inflammation will be made in plasma	6 months