Mild Cognitive ImpairmentNCT02023645
The Effects of a Carotenoid Intervention on Cognitive Function
A study testing active supplement in people with Mild Cognitive Impairment, run by University of Georgia at 1 site in United States.
Trial summary
Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider… Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- active supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 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 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- visual acuity correctable to 20:40 or better, Snellen notation
- able to swallow a dietary supplement
- free of dementia, characterized by a score of less than 1.5 on the Clinical Dementia Rating Scale
Who cannot join
- GI conditions that interfere with lipid absorption
- presence of or past diagnosis of age-related macular degeneration
- visual acuity poorer than 20:40, Snellen notation
- has taken lutein, omega-3 fatty acid or fish oil supplements within the last 6 months
- presence of dementia, characterized by a score of 1.5 or greater on the Clinical Dementia Rating Scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Lutein + Zeaxanthin Intervention on Cognitive Function and Neural Efficiency
Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider variety of methods (behavioral testing and neuroimaging).
Read the detailed description
Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider variety of methods (behavioral testing and neuroimaging).
- Conditions
- Mild Cognitive Impairment
- Being tested
- active supplement, placebo
- Keywords
- lutein, cognition, neural efficiency, aging
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active supplementDietary supplement
Also called FloraGlo lutein
tablet
placeboOther
Also called inert placebo
tablet
| Study group | Role | What they receive |
|---|---|---|
| Active supplement | Experimental | 10 mg lutein + 2 mg zeaxanthin Receives: Dietary Supplement: active supplement |
| inert placebo | Placebo comparator | placebo for comparison Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
macular pigment optical density
optical density of macular pigment layer in central retina, defined in log units of optical density
Measured: 12 months
Secondary outcomes (5)
serum carotenoid levels
serum carotenoids will be measured via high performance liquid chromatography
Measured: 12 months
reaction time
reaction (msec) to a light stimulus
Measured: 12-months
executive function
computerized composite score from computerized battery
Measured: 12-months
short-term memory
composite score from a computerized battery
Measured: 12-months
visual attention
composite score from computerized battery
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition, dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Billy R. Hammond, University of Georgia
- Investigators
- Billy R Hammond, Ph.D., Principal investigator, The University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023645
- Sponsor's protocol ID
- 2012-10516
- Status last verified
- May 2015
- First submitted
- 16 Dec 2013
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mewborn CM, Lindbergh CA, Hammond BR, Renzi-Hammond LM, Miller LS. The Effects of Lutein and Zeaxanthin Supplementation on Brain Morphology in Older Adults: A Randomized, Controlled Trial. J Aging Res. 2019 Dec 1;2019:3709402. doi: 10.1155/2019/3709402. eCollection 2019.
PubMed 31871787
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Lutein + Zeaxanthin Intervention on Cognitive Function and Neural Efficiency
- ClinicalTrials.gov ID
- NCT02023645
- Acronym / sponsor ID
- 2012-10516
- Conditions
- Mild Cognitive Impairment
- Keywords
- lutein, cognition, neural efficiency, aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- Abbott Nutrition, dsm-firmenich Switzerland AG
- Study start
- Jan 2012
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Dec 2013 (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.
Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider variety of methods (behavioral testing and neuroimaging).
Detailed description
Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider variety of methods (behavioral testing and neuroimaging).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active supplement | Experimental | Dietary Supplement: active supplement10 mg lutein + 2 mg zeaxanthin |
| inert placebo | Placebo comparator | Other: placeboplacebo for comparison |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- visual acuity correctable to 20:40 or better, Snellen notation
- able to swallow a dietary supplement
- free of dementia, characterized by a score of less than 1.5 on the Clinical Dementia Rating Scale
Key exclusion criteria (5 listed)
- GI conditions that interfere with lipid absorption
- presence of or past diagnosis of age-related macular degeneration
- visual acuity poorer than 20:40, Snellen notation
- has taken lutein, omega-3 fatty acid or fish oil supplements within the last 6 months
- presence of dementia, characterized by a score of 1.5 or greater on the Clinical Dementia Rating Scale
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 |
|---|---|---|
| active supplementAlso: FloraGlo luteintablet | Dietary supplement | Active supplement |
| placeboAlso: inert placebotablet | Other | inert placebo |
Primary outcome
macular pigment optical density
Time frame: 12 months
optical density of macular pigment layer in central retina, defined in log units of optical density
5 secondary outcomes
serum carotenoid levels
Time frame: 12 months
reaction time
Time frame: 12-months
executive function
Time frame: 12-months
short-term memory
Time frame: 12-months
visual attention
Time frame: 12-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Derived from this study: PubMed 31871787Mewborn CM, Lindbergh CA, Hammond BR, Renzi-Hammond LM, Miller LS. The Effects of Lutein and Zeaxanthin Supplementation on Brain Morphology in Older Adults: A Randomized, Controlled Trial. J Aging Res. 2019 Dec 1;2019:3709402. doi: 10.1155/2019/3709402. eCollection 2019.
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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.
Billy R Hammond, Ph.D. principal investigator
The University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active supplement in people with Mild Cognitive Impairment, run by University of Georgia 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 May 2015. 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?
Results are not available in the source record.
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?
macular pigment optical density (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02023645, which also lists 1 linked publication.
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 27 May 2015.