Eye HealthNCT00718653
Effects of Antioxidants on Human Macular Pigments
A study testing Lutein and Lutein plus green tea extract in people with Eye Health, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
Age-related macular degeneration (AMD) is the leading cause of blindness in the United States. Low dietary intake or low blood levels of lutein and zeaxanthin, which are the only pigments found in the macular region of the human retina, has been associated with an increased risk for AMD. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Health
- What is being tested?
- Lutein and Lutein plus green tea extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Dec 2007
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption and no drug intake which would interfere with fat absorption, metabolism or blood clotting
- non-smokers
Who cannot join
- A history of kidney stones, active small bowel disease or resection, atrophic gastritis, hyperlipidemia, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders
- Exogenous hormone users
- weighing greater than 20% above or below the NHANES median standard
- subjects with serum lutein/zeaxanthin concentrations that are more than 150 % of median of normal population (as previously reported in NHANES III at same age group)
- early age related macular degeneration, cataract, or glaucoma except for those with age appropriate progression of the eye status.
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
Age-related macular degeneration (AMD) is the leading cause of blindness in the United States. Low dietary intake or low blood levels of lutein and zeaxanthin, which are the only pigments found in the macular region of the human retina, has been associated with an increased risk for AMD. We have reported that the dietary supplementation of lutein and zeaxanthin can increase the macular pigments (MP) of the eye. MP effectively absorbs blue light as well as quenches reactive oxygen species (ROS). Green tea polyphenols are also effective scavenger of ROS in vitro.
Our goal is to elucidate how to effectively increase MP by physiologic levels of antioxidant supplementation. We hypothesize that lutein and tea polyphenols protect the macula of the eye by increasing MP carotenoids effectively through an antioxidant mechanism.
- Conditions
- Eye Health
- Being tested
- Lutein, Lutein plus green tea extract
- Keywords
- Macular pigment, lutein, green tea extract, antioxidant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuteinDietary supplement
Lutein (12 mg/d)
Lutein plus green tea extractDietary supplement
lutein (12 mg/d) plus green tea extract (200 mg/d)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | lutein Receives: Dietary Supplement: Lutein |
| 2 | Experimental | Lutein plus green tea extract Receives: Dietary Supplement: Lutein plus green tea extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
macular pigments, Plasma lutein concentrations
Measured: Every month - baseline, 1, 2, 3, & 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startSep 2004
- Primary completionDec 2007
- Study completionDec 2007
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 Eye HealthStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Kyung-Jin Yeum, Ph.D., Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718653
- Sponsor's protocol ID
- R03EY015674
- Other IDs
- R03EY015674
- Status last verified
- Feb 2009
- First submitted
- 17 Jul 2008
- Last updated
- 3 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Li L, Duker JS, Yoshida Y, Niki E, Rasmussen H, Russell RM, Yeum KJ. Oxidative stress and antioxidant status in older adults with early cataract. Eye (Lond). 2009 Jun;23(6):1464-8. doi: 10.1038/eye.2008.281. Epub 2008 Sep 19.
PubMed 18806766
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antioxidants on Human Macular Pigments
- ClinicalTrials.gov ID
- NCT00718653
- Acronym / sponsor ID
- R03EY015674
- Conditions
- Eye Health
- Keywords
- Macular pigment, lutein, green tea extract, antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Sep 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Jul 2008 (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.
Age-related macular degeneration (AMD) is the leading cause of blindness in the United States. Low dietary intake or low blood levels of lutein and zeaxanthin, which are the only pigments found in the macular region of the human retina, has been associated with an increased risk for AMD. We have reported that the dietary supplementation of lutein and zeaxanthin can increase the macular pigments (MP) of the eye. MP effectively absorbs blue light as well as quenches reactive oxygen species (ROS). Green tea polyphenols are also effective scavenger of ROS in vitro.
Our goal is to elucidate how to effectively increase MP by physiologic levels of antioxidant supplementation. We hypothesize that lutein and tea polyphenols protect the macula of the eye by increasing MP carotenoids effectively through an antioxidant mechanism.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Luteinlutein |
| 2 | Experimental | Dietary Supplement: Lutein plus green tea extractLutein plus green tea extract |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption and no drug intake which would interfere with fat absorption, metabolism or blood clotting
- non-smokers
Key exclusion criteria (5 listed)
- A history of kidney stones, active small bowel disease or resection, atrophic gastritis, hyperlipidemia, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders
- Exogenous hormone users
- weighing greater than 20% above or below the NHANES median standard
- subjects with serum lutein/zeaxanthin concentrations that are more than 150 % of median of normal population (as previously reported in NHANES III at same age group)
- early age related macular degeneration, cataract, or glaucoma except for those with age appropriate progression of the eye status.
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 |
|---|---|---|
| LuteinLutein (12 mg/d) | Dietary supplement | 1 |
| Lutein plus green tea extractlutein (12 mg/d) plus green tea extract (200 mg/d) | Dietary supplement | 2 |
Primary outcome
macular pigments, Plasma lutein concentrations
Time frame: Every month - baseline, 1, 2, 3, & 4 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 3 Mar 2009.
- Results publication: PubMed 18806766Li L, Duker JS, Yoshida Y, Niki E, Rasmussen H, Russell RM, Yeum KJ. Oxidative stress and antioxidant status in older adults with early cataract. Eye (Lond). 2009 Jun;23(6):1464-8. doi: 10.1038/eye.2008.281. Epub 2008 Sep 19.
- Related InfoLink provided by the sponsor.
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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.
Kyung-Jin Yeum, Ph.D. principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutein and Lutein plus green tea extract in people with Eye Health, run by National Eye Institute (NEI) 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 2 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: finished, as of the sponsor's last update on 3 Mar 2009. 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. 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?
macular pigments, Plasma lutein concentrations (time frame: Every month - baseline, 1, 2, 3, & 4 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 NCT00718653, 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 3 Mar 2009.