Changes in Macular Pigment Optical DensityKALESIGHTNCT02136303
Regional Kale as Source of Lutein and Zeaxanthin to Improve Vision of AMD-patients
A study testing S1: Dosage-dependency, S2: Kale extract versus kale purée and S3: Kale extract: AMD-patients in people with Changes in Macular Pigment Optical Density, run by University of Jena at 1 site in Germany.
Trial summary
The age-related macular degeneration (AMD) is an age-dependent, multi-factorial disease. In Western industrial countries, it is the main cause of visual impairments. In Germany, approximately 4.5 million people suffer from AMD. Genetic as well as nutritional aspects are mainly important in AMD development. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Changes in Macular Pigment Optical Density
- What is being tested?
- S1: Dosage-dependency, S2: Kale extract versus kale purée and S3: Kale extract: AMD-patients
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy, > 18 years, written consent
Who cannot join
- uptake of dietary supplements, glaucoma
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Eye Hospital, Friedrich Schiller University Jena
Jena, 07743
About this study
Official title: Regional Kale as Source of Lutein and Zeaxanthin to Improve Vision of Patients With Age-related Macular Degeneration - an Alternative to Supplements With Isolated Xanthophylls
The age-related macular degeneration (AMD) is an age-dependent, multi-factorial disease. In Western industrial countries, it is the main cause of visual impairments. In Germany, approximately 4.5 million people suffer from AMD. Genetic as well as nutritional aspects are mainly important in AMD development. Until now, AMD-patients are advised to use supplements based on the carotenoids lutein and zeaxanthin, comprised in high doses and in isolated form. Results showing the effects of food items (kale, spinach) rich in lutein on improvement of vision are scarce. And how much is needed within the diet? Within the planned project, human intervention studies will investigate whether an oil-based kale extract or fresh kale can be used to improve vision of AMD-patients and persons aged 50+ (without AMD). The first study will use volunteers without AMD (>18 y) to investigate if there is a dose-dependent effect of lutein and zeaxanthin (out of a kale extract) on macular pigment optical density (MPOD). This study will also compare the bioavailability of the carotenoids from the extract and from a supplement. A second study (also using volunteers without AMD, >18 y) will compare the bioavailability of lutein and zeaxanthin from the extract and from kale purée. The third study will investigate the effect of the oil-based kale extract on improvements of MPOD and vision of AMD-patients and of a control group (volunteers 50+ without AMD).
Usually, the intestinal absorption of lutein and zeaxanthin is determined by analyzing changes in concentrations in blood plasma. A fast, non-invasive sampling will be evaluated to check the efficacy of an increased uptake of lutein. Thus, the project will test the usability of buccal mucosa cells to detect metabolic changes after an uptake of carotenoids. Besides, the determination of carotenoid contents in skin will be checked on its use as biomarker of carotenoids in plasma and macula.
Thus, the planned research project will evaluate two non-invasive markers of exposition on their usability as markers of absorption of lutein and zeaxanthin in blood and macula. In addition, the minimally needed dosage of lutein and zeaxanthin for AMD prevention will be determined to reduce the possible risk of currently recommended doses of these compounds. The project will also present alternatives (kale extract, kale purée) for AMD prevention and to improve vision to be used instead of currently used high-dose supplements.
- Being tested
- S1: Dosage-dependency, S2: Kale extract versus kale purée, S3: Kale extract: AMD-patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1: Dosage-dependencyDietary supplement
kale extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein tagetes extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein, 10 mg lutein
S2: Kale extract versus kale puréeOther
S3: Kale extract: AMD-patientsOther
| Study group | Role | What they receive |
|---|---|---|
| S1-Placebo | Placebo comparator | placebo capsule with all ingredients, but without active compound, intervention for 4 weeks, S1: Dosage-dependency Receives: Dietary Supplement: S1: Dosage-dependency |
| S1-1L | Experimental | capsule containing 1 mg lutein out of kale, intervention for 4 weeks, S1: Dosage-dependency Receives: Dietary Supplement: S1: Dosage-dependency |
| S1-2L | Experimental | capsule containing 2 mg lutein out of kale, intervention for 4 weeks, S1: Dosage-dependency Receives: Dietary Supplement: S1: Dosage-dependency |
| S1-5L | Experimental | capsule containing 5 mg lutein out of kale, intervention for 4 weeks, S1: Dosage-dependency Receives: Dietary Supplement: S1: Dosage-dependency |
| S2-Kale_extract | Experimental | Not described Receives: Other: S2: Kale extract versus kale purée |
| S2-Kale_purée | Experimental | Not described Receives: Other: S2: Kale extract versus kale purée |
| S3-Placebo | Placebo comparator | Not described Receives: Other: S3: Kale extract: AMD-patients |
| S3-AMD-Patients | Experimental | Not described Receives: Other: S3: Kale extract: AMD-patients |
| S3-non-AMD | Experimental | Not described Receives: Other: S3: Kale extract: AMD-patients |
| S1-Placebo-Tagetes | Placebo comparator | capsule containing all ingredients, but without active compound, intervention for 4 weeks, S1: Dosage-dependency Receives: Dietary Supplement: S1: Dosage-dependency |
| S1-1L-Tagetes | Experimental | capsule containing 1 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency Receives: Dietary Supplement: S1: Dosage-dependency |
| S1-2L-Tagetes | Experimental | capsule containing 2 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency Receives: Dietary Supplement: S1: Dosage-dependency |
| S1-5L-Tagetes | Experimental | capsule containing 5 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency Receives: Dietary Supplement: S1: Dosage-dependency |
| S1-10L-Tagetes | Experimental | capsule containing 10 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency Receives: Dietary Supplement: S1: Dosage-dependency |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in macular pigment optical density MPOD [ODU: optical density units]
Changes from baseline to various time points for different parameters of MPOD will be measured: changes in mean MPOD [ODU], changes in max. MPOD [ODU], changes in volume of MPOD [ODU x (degree)2], changes in area of MPOD [degree2]
Measured: baseline and after 4/8 weeks, baseline and after 6/12/18/24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Changes in Macular Pigment Optical DensityStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volker Boehm, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136303
- Sponsor's protocol ID
- BO 1511/8-1
- Acronym
- KALESIGHT
- Status last verified
- May 2018
- First submitted
- 6 May 2014
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Arnold C, Winter L, Frohlich K, Jentsch S, Dawczynski J, Jahreis G, Bohm V. Macular xanthophylls and omega-3 long-chain polyunsaturated fatty acids in age-related macular degeneration: a randomized trial. JAMA Ophthalmol. 2013 May;131(5):564-72. doi: 10.1001/jamaophthalmol.2013.2851.
PubMed 23519529Arnold C, Jentsch S, Dawczynski J, Bohm V. Age-related macular degeneration: Effects of a short-term intervention with an oleaginous kale extract--a pilot study. Nutrition. 2013 Nov-Dec;29(11-12):1412-7. doi: 10.1016/j.nut.2013.05.012.
PubMed 24103519
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Kale as Source of Lutein and Zeaxanthin to Improve Vision of Patients With Age-related Macular Degeneration - an Alternative to Supplements With Isolated Xanthophylls
- ClinicalTrials.gov ID
- NCT02136303
- Acronym / sponsor ID
- KALESIGHT / BO 1511/8-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 May 2014 (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 age-related macular degeneration (AMD) is an age-dependent, multi-factorial disease. In Western industrial countries, it is the main cause of visual impairments. In Germany, approximately 4.5 million people suffer from AMD. Genetic as well as nutritional aspects are mainly important in AMD development. Until now, AMD-patients are advised to use supplements based on the carotenoids lutein and zeaxanthin, comprised in high doses and in isolated form. Results showing the effects of food items (kale, spinach) rich in lutein on improvement of vision are scarce. And how much is needed within the diet? Within the planned project, human intervention studies will investigate whether an oil-based kale extract or fresh kale can be used to improve vision of AMD-patients and persons aged 50+ (without AMD). The first study will use volunteers without AMD (>18 y) to investigate if there is a dose-dependent effect of lutein and zeaxanthin (out of a kale extract) on macular pigment optical density (MPOD). This study will also compare the bioavailability of the carotenoids from the extract and from a supplement. A second study (also using volunteers without AMD, >18 y) will compare the bioavailability of lutein and zeaxanthin from the extract and from kale purée. The third study will investigate the effect of the oil-based kale extract on improvements of MPOD and vision of AMD-patients and of a control group (volunteers 50+ without AMD).
Usually, the intestinal absorption of lutein and zeaxanthin is determined by analyzing changes in concentrations in blood plasma. A fast, non-invasive sampling will be evaluated to check the efficacy of an increased uptake of lutein. Thus, the project will test the usability of buccal mucosa cells to detect metabolic changes after an uptake of carotenoids. Besides, the determination of carotenoid contents in skin will be checked on its use as biomarker of carotenoids in plasma and macula.
Thus, the planned research project will evaluate two non-invasive markers of exposition on their usability as markers of absorption of lutein and zeaxanthin in blood and macula. In addition, the minimally needed dosage of lutein and zeaxanthin for AMD prevention will be determined to reduce the possible risk of currently recommended doses of these compounds. The project will also present alternatives (kale extract, kale purée) for AMD prevention and to improve vision to be used instead of currently used high-dose supplements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| S1-Placebo | Placebo comparator | Dietary Supplement: S1: Dosage-dependencyplacebo capsule with all ingredients, but without active compound, intervention for 4 weeks, S1: Dosage-dependency |
| S1-1L | Experimental | Dietary Supplement: S1: Dosage-dependencycapsule containing 1 mg lutein out of kale, intervention for 4 weeks, S1: Dosage-dependency |
| S1-2L | Experimental | Dietary Supplement: S1: Dosage-dependencycapsule containing 2 mg lutein out of kale, intervention for 4 weeks, S1: Dosage-dependency |
| S1-5L | Experimental | Dietary Supplement: S1: Dosage-dependencycapsule containing 5 mg lutein out of kale, intervention for 4 weeks, S1: Dosage-dependency |
| S2-Kale_extract | Experimental | Other: S2: Kale extract versus kale purée |
| S2-Kale_purée | Experimental | Other: S2: Kale extract versus kale purée |
| S3-Placebo | Placebo comparator | Other: S3: Kale extract: AMD-patients |
| S3-AMD-Patients | Experimental | Other: S3: Kale extract: AMD-patients |
| S3-non-AMD | Experimental | Other: S3: Kale extract: AMD-patients |
| S1-Placebo-Tagetes | Placebo comparator | Dietary Supplement: S1: Dosage-dependencycapsule containing all ingredients, but without active compound, intervention for 4 weeks, S1: Dosage-dependency |
| S1-1L-Tagetes | Experimental | Dietary Supplement: S1: Dosage-dependencycapsule containing 1 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency |
| S1-2L-Tagetes | Experimental | Dietary Supplement: S1: Dosage-dependencycapsule containing 2 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency |
| S1-5L-Tagetes | Experimental | Dietary Supplement: S1: Dosage-dependencycapsule containing 5 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency |
| S1-10L-Tagetes | Experimental | Dietary Supplement: S1: Dosage-dependencycapsule containing 10 mg lutein out of tagetes, intervention for 4 weeks, S1: Dosage-dependency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy, > 18 years, written consent
Key exclusion criteria (1 listed)
- uptake of dietary supplements, glaucoma
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 |
|---|---|---|
| S1: Dosage-dependencykale extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein tagetes extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein, 10 mg lutein | Dietary supplement | S1-10L-Tagetes, S1-1L, S1-1L-Tagetes, S1-2L, S1-2L-Tagetes, S1-5L, S1-5L-Tagetes, S1-Placebo, S1-Placebo-Tagetes |
| S2: Kale extract versus kale purée | Other | S2-Kale_extract, S2-Kale_purée |
| S3: Kale extract: AMD-patients | Other | S3-AMD-Patients, S3-Placebo, S3-non-AMD |
Primary outcome
changes in macular pigment optical density MPOD [ODU: optical density units]
Time frame: baseline and after 4/8 weeks, baseline and after 6/12/18/24 weeks
Changes from baseline to various time points for different parameters of MPOD will be measured: changes in mean MPOD [ODU], changes in max. MPOD [ODU], changes in volume of MPOD [ODU x (degree)2], changes in area of MPOD [degree2]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Results publication: PubMed 23519529Arnold C, Winter L, Frohlich K, Jentsch S, Dawczynski J, Jahreis G, Bohm V. Macular xanthophylls and omega-3 long-chain polyunsaturated fatty acids in age-related macular degeneration: a randomized trial. JAMA Ophthalmol. 2013 May;131(5):564-72. doi: 10.1001/jamaophthalmol.2013.2851.
- Results publication: PubMed 24103519Arnold C, Jentsch S, Dawczynski J, Bohm V. Age-related macular degeneration: Effects of a short-term intervention with an oleaginous kale extract--a pilot study. Nutrition. 2013 Nov-Dec;29(11-12):1412-7. doi: 10.1016/j.nut.2013.05.012.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S1: Dosage-dependency, S2: Kale extract versus kale purée and S3: Kale extract: AMD-patients in people with Changes in Macular Pigment Optical Density, run by University of Jena at 1 site in Germany.
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 1 inclusion and 1 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 8 May 2018. 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 Germany. 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?
Contact Volker Böhm, Dr. (+49-(0)3641-949633, Volker.Boehm@uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in macular pigment optical density MPOD [ODU: optical density units] (time frame: baseline and after 4/8 weeks, baseline and after 6/12/18/24 weeks). 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 NCT02136303, which also lists 2 linked publications.
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 8 May 2018.