Age-related Macular Degeneration (AMD)I-TEAMNCT01694680
Intervention Trial in Early Age-related Macular Degeneration
A study testing Lutein-enriched-egg beverage (NWT-02) in people with Age-related Macular Degeneration (AMD), run by Newtricious R&D BV at 4 sites in 4 countries.
Trial summary
The purpose of the I-TEAM project is to assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of Age-related Macular Degeneration. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration (AMD)
- What is being tested?
- Lutein-enriched-egg beverage (NWT-02)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Oct 2012to Apr 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early AMD (AREDS category 2)
- many small drusen, or
- a few intermediate-sized (63-124 micrometres in diameter) drusen, or
- macular pigmentary changes
- OR
- Intermediate AMD (AREDS category 3)
Show all 19Show fewer
- extensive intermediate sized (63-124 micrometres in diameter) drusen, or
- at least one large (>125 micrometers in diameter) drusen or
- geographic atrophy not involving the foveal centre
- men and women age ≥50 years
- BMI 18-35 kg/m2
- Vision ≥ 20/40 for Snellen visual acuity
- lutein intake of < 2 mg/day (including supplements)
- DHA intake of < 150 mg/day (including supplements)
- must be able to give written informed consent
- have normal hematologic parameters
- normal values of plasma albumin
- normal values for liver and kidney function
- no use of carotenoid, fish oil, or n3 fatty acid supplements (within 1 month of study start)
Who cannot join
- ocular media opacity (severe cataract)
- history of active small bowel disease or resection
- atrophic gastritis
- history of hyperlipidemia or screening values as follows (LDL > 5.33mmol/L or 205mg/dL; triglycerides > 4.52mmol/L or >400 mg/dL)
- hypertension (>150/90 mm Hg)
- diabetes mellitus (if also accompanied by signs of diabetic retinopathy)
Show all 24Show fewer
- alcohol intake of >2 drinks/day or 14 drinks/week
- pancreatic disease
- dementia or Alzheimer's disease
- anemia, and bleeding disorders
- known allergy to egg or egg products
- known allergy to milk or milk products
- known allergy to cocoa or chocolate products
- known allergy to fish or fish oils
- lactose intolerance
- pregnancy or lactation
- diseases that interfere with fat absorption, e.g. colitis, celiac disease, Crohn's disease, cystic fibrosis (as determined by screening interview)
- medication or supplements that contain a significant level of carotenoids, including an amount of lutein of more than 0.25 mg per day within 1 month of the study start
- medications that interfere with fat absorption, e.g. bile sequestrants (as determined by screening interview)
- use of antipsychotic, anti manic, or dementia medications
- smoking or use of nicotine patches or gum (within the past 6 months)
- subjects having extremely high dietary intakes of carotenoids
- stroke, head injury with loss of consciousness or seizures
- for US and UK center: Non English speaking
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United Kingdom1 site
Manchester Royal Eye Hospital - Manchester
Manchester
About this study
Official title: Intervention Study to Assess the Effect of Daily Consumption of a Lutein-enriched-egg Beverage on Maintenance of Visual Function in Subjects With Early Signs of Age-related Macular Degeneration
The purpose of the I-TEAM project is to assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of Age-related Macular Degeneration.
- Conditions
- Age-related Macular Degeneration (AMD)
- Being tested
- Lutein-enriched-egg beverage (NWT-02), Placebo
- Keywords
- AMD, Lutein, Visual function, Early signs of AMD, AREDS-category 2
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutein-enriched-egg beverage (NWT-02)Dietary supplement
Lutein, zeaxanthin and DHA-enriched-egg yolk combined with buttermilk beverage
PlaceboDietary supplement
color-, taste- and energy-matched powder without enriched egg-yolk
| Study group | Role | What they receive |
|---|---|---|
| Lutein-enriched-egg beverage | Active comparator | Powder in sachets is provided and dissolved to prepare Lutein-enriched-egg beverage Receives: Dietary Supplement: Lutein-enriched-egg beverage (NWT-02) |
| Placebo | Placebo comparator | Powder in sachet to prepare beverage Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual function
Measured: 12 months
Secondary outcomes (1)
Carotenoid levels
Levels of lutein and Zeaxanthin
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 posted27 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2016
- Study completionApr 2016
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 Age-related Macular Degeneration (AMD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newtricious R&D BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Responsible party
- Sponsor
- Investigators
- E J Johnson, PhD, Principal investigator, Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA), Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694680
- Sponsor's protocol ID
- NWT-02/Human 4
- Acronym
- I-TEAM
- Status last verified
- Sep 2016
- First submitted
- 25 Sep 2012
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.
PubMed 37702300
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study to Assess the Effect of Daily Consumption of a Lutein-enriched-egg Beverage on Maintenance of Visual Function in Subjects With Early Signs of Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01694680
- Acronym / sponsor ID
- I-TEAM / NWT-02/Human 4
- Conditions
- Age-related Macular Degeneration (AMD)
- Keywords
- AMD, Lutein, Visual function, Early signs of AMD, AREDS-category 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Newtricious R&D BVIndustry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- Oct 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Sep 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.
The purpose of the I-TEAM project is to assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of Age-related Macular Degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lutein-enriched-egg beverage | Active comparator | Dietary Supplement: Lutein-enriched-egg beverage (NWT-02)Powder in sachets is provided and dissolved to prepare Lutein-enriched-egg beverage |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPowder in sachet to prepare beverage |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Early AMD (AREDS category 2)
- OR
- Intermediate AMD (AREDS category 3)
- men and women age ≥50 years
- BMI 18-35 kg/m2
Key exclusion criteria (24 listed)
- ocular media opacity (severe cataract)
- history of active small bowel disease or resection
- atrophic gastritis
- history of hyperlipidemia or screening values as follows (LDL > 5.33mmol/L or 205mg/dL; triglycerides > 4.52mmol/L or >400 mg/dL)
- hypertension (>150/90 mm Hg)
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 |
|---|---|---|
| Lutein-enriched-egg beverage (NWT-02)Lutein, zeaxanthin and DHA-enriched-egg yolk combined with buttermilk beverage | Dietary supplement | Lutein-enriched-egg beverage |
| Placebocolor-, taste- and energy-matched powder without enriched egg-yolk | Dietary supplement | Placebo |
Primary outcome
Visual function
Time frame: 12 months
1 secondary outcome
Carotenoid levels
Time frame: 12 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 21 Sep 2016.
- Derived from this study: PubMed 37702300Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.
Related trials for Age-related Macular Degeneration (AMD)
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
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.
E J Johnson, PhD principal investigator
Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA), Boston
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutein-enriched-egg beverage (NWT-02) in people with Age-related Macular Degeneration (AMD), run by Newtricious R&D BV at 4 sites in 4 countries.
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 19 inclusion and 24 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 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany, Netherlands, United Kingdom. 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?
Visual function (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 NCT01694680, 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 21 Sep 2016.