Nutrition Deficiency (Xanth Deficiency) Due to A Particular Kind of FoodXanthovisionNCT05794074
Role of Xanthophylls in Visual Function
A study testing luteine and zeaxanthine, luteine and zeaxanthine in people with Nutrition Deficiency (Xanth Deficiency) Due to A Particular Kind of Food, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Ecy of lutein supplementation alone, or zeaxanthin supplementation alone, or a combination of both, compared to placebo, on the evolution of macular pigment density (MPOD) measured by fundus photography in XANTH-deficient patients receiving enteral nutrition. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Nutrition Deficiency (Xanth Deficiency) Due to A Particular Kind of Food
- What is being tested?
- luteine and zeaxanthine, luteine and zeaxanthine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- On exclusive enteral nutrition for at least 6 months
- Exclusive enteral nutrition that is intended to be continued for at least 6 more months.
- No XANTH supplementation in the last 6 months.
- Able to sit up to allow visual examinations to be performed
- Sufficient understanding to perform visual examinations, at the discretion of the physician
- Written consent signed by the patient or agreement of their carer, trusted person, relative, family for patients with cognitive impairment (assessed using an MMS test). A patient with an MMSE test result ≤ 24 will be considered as having cognitive disorders.
Who cannot join
- Current treatment with hydroxychloroquine or any other drug known to cause ocular toxicity
- Visually impaired patient: patient unable to read text (font size 11) at close range, with visual correction if the patient usually wears it
- Unoperated cataracts in both eyes
- Pregnant or breastfeeding woman
- Patient under legal protection: guardianship or curatorship
- Participation in other research in the same field of dietary supplementation, which may interfere with the results of this research.
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- Secondary exclusion criteria :
- Absence of XANTH (lutein and zeaxanthin) deficiency* in the blood sample taken at inclusion.
- Physical, ophthalmological or cognitive characteristics, evaluated at the Quinze-Vingt ophthalmological examination, which do not allow a reliable measurement of MPOD or of all the settings of visual function.
About this study
Ecy of lutein supplementation alone, or zeaxanthin supplementation alone, or a combination of both, compared to placebo, on the evolution of macular pigment density (MPOD) measured by fundus photography in XANTH-deficient patients receiving enteral nutrition.
Read the detailed description
Lutein and zeaxanthin are plant pigments belonging to the carotenoid family, and more precisely to the subfamily of xanthophylls (XANTH), which are oxygenated carotenoids. These phytochemicals are not synthesised by humans and are almost always present in our diet. They are significantly absorbed and transported in our body. They are present in various organs, e.g. the eye and the skin. They accumulate in very high concentrations in the central area of the human retina. Because of this high accumulation, it has been hypothesised that they play one or more specific roles in the eye. This has been confirmed by several studies which have shown that XANTHs are involved in protecting the eye from damage by certain light rays (blue) and age-related macular degeneration. Other studies suggest that XANTH may improve glare tolerance and contrast sensitivity. They may also improve sensitivity to red and green colour discrimination. However, identifying the exact relationship between XANTH and visual function in XANTH supplementation is complicated by two main problems. Firstly, XANTH supplementation does not always increase MPOD (Macular Pigment Optical Density), which is an indicator of the concentration of XANTH in the macula, because there are poor responders to XANTH, i.e. subjects who absorb it very poorly and/or transport it very poorly to the retina. Secondly, MPOD seems to reach a maximum value and a plateau, and increasing the dose of XANTH, or the duration of supplementation, does not increase MPOD further. This is particularly the case in individuals who already have a high MPOD, close to the maximum value, before supplementation because they often consume XANTH-rich foods, and/or because they are strong responders to XANTH. Therefore, although studies suggest a specific role for XANTH in visual function, the problem of initially high MPOD in some individuals, coupled with MPOD saturation, has not allowed previous studies to provide definitive evidence on their role(s) in visual function.
- Being tested
- luteine and zeaxanthine, luteine, zeaxanthine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
luteine and zeaxanthineDietary supplement
luteine and zeaxanthine
luteineDietary supplement
luteine
zeaxanthineDietary supplement
zeaxanthine
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| lutéine | Experimental | 10 mg/d lutéine Receives: Dietary Supplement: luteine |
| zeaxanthine | Experimental | 10 mg/d zéaxanthine Receives: Dietary Supplement: zeaxanthine |
| lutéine and zeaxanthine | Experimental | 10 mg/d lutéine + 2 mg/d zéaxanthine Receives: Dietary Supplement: luteine and zeaxanthine |
| placebo | Placebo comparator | same excipient used in the other arms with a carmine red dye Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of MPOD Baseline Vs M6
Changes in MPOD by fundus photography (blue light autofluorescence) from baseline to 6 months of supplementation (M6) with lutein or zeaxanthin, or a combination of both, vs placebo.
Measured: Baseline, month 6
Secondary outcomes (3)
Linkage between MPDO and visual settings
evaluate the relation between MPOD and visual accuity/settings
Measured: Baseline, Month 6
Linkage between MPOD and blood and xanth blodd count
evaluate the relation between MPOD and Xanth blood count
Measured: Baseline, Month 4 and Month 13(option)
Measurement of visual accuity and settings
Measurement of visual accuity and settings assessed in a standardised manner at the Quinze-Vingt by :
- Retinal structure assessed by OCT and adaptive optics
- Visual acuity
- Central macular sensitivity measured by microperimetry
- Colour vision, especially in blue
- Contrast sensitivity
- Glare sensitivity and dark adaptation.
- SLO Imaging
Measured: Baseline, Month 4, Month 7, Month 13(option)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Deficiency (Xanth Deficiency) Due to A Particular Kind of FoodStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794074
- Sponsor's protocol ID
- APHP220293
- Acronym
- Xanthovision
- Status last verified
- Jan 2023
- First submitted
- 3 Feb 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Xanthophylls in Visual Function
- ClinicalTrials.gov ID
- NCT05794074
- Acronym / sponsor ID
- Xanthovision / APHP220293
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 31 Mar 2023 (actual)
- 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.
Ecy of lutein supplementation alone, or zeaxanthin supplementation alone, or a combination of both, compared to placebo, on the evolution of macular pigment density (MPOD) measured by fundus photography in XANTH-deficient patients receiving enteral nutrition.
Detailed description
Lutein and zeaxanthin are plant pigments belonging to the carotenoid family, and more precisely to the subfamily of xanthophylls (XANTH), which are oxygenated carotenoids. These phytochemicals are not synthesised by humans and are almost always present in our diet. They are significantly absorbed and transported in our body. They are present in various organs, e.g. the eye and the skin. They accumulate in very high concentrations in the central area of the human retina. Because of this high accumulation, it has been hypothesised that they play one or more specific roles in the eye. This has been confirmed by several studies which have shown that XANTHs are involved in protecting the eye from damage by certain light rays (blue) and age-related macular degeneration. Other studies suggest that XANTH may improve glare tolerance and contrast sensitivity. They may also improve sensitivity to red and green colour discrimination. However, identifying the exact relationship between XANTH and visual function in XANTH supplementation is complicated by two main problems. Firstly, XANTH supplementation does not always increase MPOD (Macular Pigment Optical Density), which is an indicator of the concentration of XANTH in the macula, because there are poor responders to XANTH, i.e. subjects who absorb it very poorly and/or transport it very poorly to the retina. Secondly, MPOD seems to reach a maximum value and a plateau, and increasing the dose of XANTH, or the duration of supplementation, does not increase MPOD further. This is particularly the case in individuals who already have a high MPOD, close to the maximum value, before supplementation because they often consume XANTH-rich foods, and/or because they are strong responders to XANTH. Therefore, although studies suggest a specific role for XANTH in visual function, the problem of initially high MPOD in some individuals, coupled with MPOD saturation, has not allowed previous studies to provide definitive evidence on their role(s) in visual function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lutéine | Experimental | Dietary Supplement: luteine10 mg/d lutéine |
| zeaxanthine | Experimental | Dietary Supplement: zeaxanthine10 mg/d zéaxanthine |
| lutéine and zeaxanthine | Experimental | Dietary Supplement: luteine and zeaxanthine10 mg/d lutéine + 2 mg/d zéaxanthine |
| placebo | Placebo comparator | Dietary Supplement: Placebosame excipient used in the other arms with a carmine red dye |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- On exclusive enteral nutrition for at least 6 months
- Exclusive enteral nutrition that is intended to be continued for at least 6 more months.
- No XANTH supplementation in the last 6 months.
- Able to sit up to allow visual examinations to be performed
- Sufficient understanding to perform visual examinations, at the discretion of the physician
Key exclusion criteria (9 listed)
- Current treatment with hydroxychloroquine or any other drug known to cause ocular toxicity
- Visually impaired patient: patient unable to read text (font size 11) at close range, with visual correction if the patient usually wears it
- Unoperated cataracts in both eyes
- Pregnant or breastfeeding woman
- Patient under legal protection: guardianship or curatorship
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 |
|---|---|---|
| luteine and zeaxanthineluteine and zeaxanthine | Dietary supplement | lutéine and zeaxanthine |
| luteineluteine | Dietary supplement | lutéine |
| zeaxanthinezeaxanthine | Dietary supplement | zeaxanthine |
| PlaceboPlacebo | Dietary supplement | placebo |
Primary outcome
evolution of MPOD Baseline Vs M6
Time frame: Baseline, month 6
Changes in MPOD by fundus photography (blue light autofluorescence) from baseline to 6 months of supplementation (M6) with lutein or zeaxanthin, or a combination of both, vs placebo.
3 secondary outcomes
Linkage between MPDO and visual settings
Time frame: Baseline, Month 6
Linkage between MPOD and blood and xanth blodd count
Time frame: Baseline, Month 4 and Month 13(option)
Measurement of visual accuity and settings
Time frame: Baseline, Month 4, Month 7, Month 13(option)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing luteine and zeaxanthine, luteine and zeaxanthine in people with Nutrition Deficiency (Xanth Deficiency) Due to A Particular Kind of Food, run by Assistance Publique - Hôpitaux de Paris.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
evolution of MPOD Baseline Vs M6 (time frame: Baseline, month 6). 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 31 Mar 2023.