Mild Cognitive ImpairmentNCT01621646
The Effect of Daily Consumption of Eggs on Cognitive Function in the Elderly
A study testing eggs or egg whites in people with Mild Cognitive Impairment, run by Tufts University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- eggs or egg whites
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
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.
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- eggs or egg whites
- Keywords
- lutein, eggs, mild cognitive impairment, elderly
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eggs or egg whitesOther
2 eggs/day or 4 oz egg whites/day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| egg white (control) | Placebo comparator | egg whites, 4 ounces per day for six months Receives: Other: eggs or egg whites |
| eggs | Experimental | eggs, 2 large per day for 6 months Receives: Other: eggs or egg whites |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognition
measures of attention, executive function, verbal fluency will be made using a sensitive computerized program
Measured: 6 months
Secondary outcomes (1)
inflammation
markers of inflammation will be made in plasma
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth J Johnson, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621646
- Sponsor's protocol ID
- 001
- Status last verified
- Aug 2017
- First submitted
- 13 Mar 2012
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01621646
- Acronym / sponsor ID
- 001
- Conditions
- Mild Cognitive Impairment
- Keywords
- lutein, eggs, mild cognitive impairment, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| egg white (control) | Placebo comparator | Other: eggs or egg whitesegg whites, 4 ounces per day for six months |
| eggs | Experimental | Other: eggs or egg whiteseggs, 2 large per day for 6 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eggs or egg whites2 eggs/day or 4 oz egg whites/day for 6 months | Other | egg white (control), eggs |
Primary outcome
cognition
Time frame: 6 months
measures of attention, executive function, verbal fluency will be made using a sensitive computerized program
1 secondary outcome
inflammation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth J Johnson, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eggs or egg whites in people with Mild Cognitive Impairment, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognition (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.