Combined Phase 1 and Phase 2 protocol
Clinical research
Published human research and the current registered study.
See the earlier peer-reviewed human study, the NCT07509229 registry record, the study design and HETCHYN’s documented role as manufacturer of the active softgel.
- Published human study
- Phase 1 / Phase 2
- Registered protocol
Adults with retinitis pigmentosa
Two treatment periods and washout
Goldschleger Eye Institute, Sheba
Clinical evidence definition
What is a clinical evidence path?
A clinical evidence path is a chronological comparison of completed published research and an active registered protocol. On this page, the 2013 JAMA Ophthalmology paper is a completed human study, while NCT07509229 is a registered Phase 1/2 protocol sponsored by Sheba Medical Center. HETCHYN is named as manufacturer of the active Dunaliella softgel; that manufacturing role is not sponsorship and does not establish a clinical outcome.
- Published record
- 2013
- Registered phases
- Phase 1 · Phase 2
- Review owner
- HETCHYN Scientific & Technical Team
Evidence-state comparison
How does a published study differ from a registered protocol?
| Evidence state | Published 2013 study | NCT07509229 registry |
|---|---|---|
| Status | Completed and peer reviewed | Enrolling by invitation under a registered protocol |
| Record type | Journal article with reported outcomes | Public protocol with planned outcomes |
| HETCHYN connection | No company role asserted on this page | Manufacturer of the active Dunaliella softgel |
| What can be concluded | Only findings supported by the paper's design | Only registry facts until results are published |
Clinical evidence reading flow
Verify a clinical evidence record in four steps.
Separate record type and roles before reading the design and checking current status.
- 01Step 1 · Record
Identify publication or registry
Determine whether the source reports completed results or describes a planned and active protocol.
- 02Step 2 · Roles
Separate sponsor and manufacturer
Confirm who controls the study and who supplies the intervention without combining those responsibilities.
- 03Step 3 · Design
Read population, dose and endpoints
Check participant criteria, intervention, comparator, duration and outcome measures.
- 04Step 4 · Status
Verify the live source before citing
Use the publication DOI or current ClinicalTrials.gov record for the latest authoritative context.
Clinical research FAQ
What should be confirmed before citing these records?
These answers keep study status, institutional roles and permissible conclusions separate.
01Is NCT07509229 a completed efficacy study?
No. It is a registered Phase 1/2 protocol currently listed as enrolling by invitation. Registry information describes the planned study and status, not completed outcomes.
02Who sponsors NCT07509229?
ClinicalTrials.gov lists Sheba Medical Center as lead sponsor. The sponsor and investigators control the protocol and clinical work.
03What is HETCHYN's documented role?
The registry names Hetchyn Ingredients Biotechnology Co., Ltd. as manufacturer of the active Dunaliella softgel intervention.
04Can the 2013 paper and current registry be treated as one study?
No. The 2013 publication reports a separate completed human study; NCT07509229 is a later registered protocol with its own design and evidence status.
05Where should the current study status be verified?
Verify the live NCT07509229 record on ClinicalTrials.gov. Registry status can change after this page is published.
Who does what
Sponsor and manufacturer are different roles.
The registry record should be read literally: Sheba Medical Center is responsible for the study, while HETCHYN is named as manufacturer of the active softgel intervention.
Sheba Medical Center
ClinicalTrials.gov lists Sheba Medical Center as lead sponsor. The sponsor, investigators and study site control the registered protocol and conduct of the clinical work.
Hetchyn Ingredients Biotechnology Co., Ltd.
The intervention description names HETCHYN as manufacturer of the active Dunaliella softgel. This manufacturing role does not make HETCHYN the study sponsor, principal investigator or clinical site.
Research timeline
One published study and one registered protocol.
The 2013 paper reports completed human research. NCT07509229 describes an active Phase 1/2 study progressing under its registered protocol. They should not be read as the same type of evidence.
Published · 2013
Randomized crossover trial in retinitis pigmentosa
The peer-reviewed JAMA Ophthalmology paper evaluated a 9-cis beta-carotene-rich Dunaliella powder and reported visual-function outcomes in adults with retinitis pigmentosa.
Read the publicationRegistered Phase 1 / Phase 2
NCT07509229 at Sheba Medical Center
A randomized, masked, crossover study compares active Dunaliella softgels with a matched corn-oil placebo. ClinicalTrials.gov lists the study as enrolling by invitation and progressing under its registered protocol.
View the live registry recordPublic registry record
ClinicalTrials.gov names HETCHYN as the intervention manufacturer.
The intervention description names Hetchyn Ingredients Biotechnology Co., Ltd. as manufacturer of the active Dunaliella softgel capsules. Sheba Medical Center remains the study sponsor.
Verify on ClinicalTrials.govClinicalTrials.govNCT07509229
SponsorSheba Medical Center
PhasePhase 1 · Phase 2
Study typeRandomized crossover
Current registry statusEnrolling by invitation
Last update posted27 July 2026
Manufacturer named in intervention recordHetchyn Ingredients Biotechnology Co., Ltd.
Active softgel: oil extraction of Dunaliella, approximately 70% 9-cis and 30% all-trans beta-carotene isomers.
Study design
What the registered protocol is designed to measure.
The design uses active and placebo periods separated by a washout, with assessments at baseline and the end of each phase.
Active period
Two active softgel capsules twice daily for 90 days; each capsule contains Dunaliella oil rich in beta-carotene.
Matched placebo
Corn-oil softgels are made to match the active capsules in size, colour and texture to maintain masking.
Six-month washout
The protocol uses an extended washout between treatment periods to reduce carry-over from circulating beta-carotene.
Measured outcomes
The primary outcome is retinal sensitivity by microperimetry, supported by retinal, visual, blood and safety measures.
Study progress
The registered Phase 1/2 study is progressing according to protocol.
NCT07509229 is moving forward through its registered study pathway. This page documents the public protocol and HETCHYN’s stated manufacturing role while the clinical work continues under the sponsor’s direction.
Explore the publication libraryScopeNCT07509229 registry facts and role boundaries
Verification sourcesClinicalTrials.gov · JAMA Ophthalmology DOI record
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