Healthy VolunteersEarly Phase 1NCT03443882
Bioavailability of Astaxanthin Formulations
A Early Phase 1 study testing Astaxanthin in people with Healthy Volunteers, run by Algatechnologies Ltd. at 1 site in Israel.
Trial summary
Bioavailability of dietary supplement formulations in healthy volunteers after a single oral dose. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Astaxanthin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Mar 2018to 30 May 2019
- Phase
- Early Phase 1
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who have signed an informed consent form and who meet all of the following entrance criteria may be enrolled in this clinical trial: Generally, healthy men and women who are 21 to 50 years of age, inclusive, at the baseline visit.
Who cannot join
- 1. Are unwilling to follow the procedures of the trial, such as making visits or having their blood drawn.
- 2. Have unintentionally lost or gained 10 or more kg of body weight in the last 3 months; 3. Have an acute illness (such as a severe cold or flu) or have been hospitalized within the past month for certain conditions; 4. Have severe co-morbid disease including cardiac, pulmonary, renal, hepatic, carotid, peripheral vascular disease, stroke, neurological, clotting disorders or active cancer; 5. Taking chronic drugs which interfere with lipids metabolism (statins or similar) 6. Consume alcohol at an elevated level (Defined as consumption of more than 10 standard alcoholic drinks per week. A standard alcoholic drink is defined as one bottle/can of beer or one glass of wine equals one portion of hard liquor).
- 7. Consume carotenoids as food supplements. 8. Have a Body Mass Index (BMI) of less than 17 or greater than 35 m/kg2; 9. Have participated in a clinical trial in the past 4 weeks; 10. Have any disease or condition that in the investigator's opinion compromises the integrity of the clinical trial or the safety of the subject; 11. Smokers 12. Pregnant woman
Trial locations and contacts
1 site in 1 country.
Israel1 site
Bert W. Strassburger Lipid Center, Sheba Medical Center,
Tel HaShomer, 52621
About this study
Bioavailability of dietary supplement formulations in healthy volunteers after a single oral dose.
Read the detailed description
Comparison of the bioavailability of 3 formulations with astaxanthin in healthy volunteers after single dose
- Conditions
- Healthy Volunteers
- Being tested
- Astaxanthin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstaxanthinDietary supplement
an oral dose form
| Study group | Role | What they receive |
|---|---|---|
| Astaxanthin formulation #1 | Active comparator | capsules Receives: Dietary Supplement: Astaxanthin |
| Astaxanthin formulation #2 | Active comparator | tablets Receives: Dietary Supplement: Astaxanthin |
| Astaxanthin formulation #3 | Active comparator | powder Receives: Dietary Supplement: Astaxanthin |
| Astaxanthin formulations | Experimental | fast condition Receives: Dietary Supplement: Astaxanthin |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma level
astaxanthin in plasma
Measured: 0-48 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start25 Mar 2018
- Primary completion2 May 2019
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algatechnologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rafael Bitzur, MD, Principal investigator, Bert W. Strassburger Lipid Center, Sheba Medical Center, Tel Hashomer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443882
- Sponsor's protocol ID
- 01 2018 ver1
- Status last verified
- Jul 2018
- First submitted
- 18 Feb 2018
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Astaxanthin Formulations
- ClinicalTrials.gov ID
- NCT03443882
- Acronym / sponsor ID
- 01 2018 ver1
- Conditions
- Healthy Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Algatechnologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2018 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 23 Feb 2018 (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.
Bioavailability of dietary supplement formulations in healthy volunteers after a single oral dose.
Detailed description
Comparison of the bioavailability of 3 formulations with astaxanthin in healthy volunteers after single dose
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Astaxanthin formulation #1 | Active comparator | Dietary Supplement: Astaxanthincapsules |
| Astaxanthin formulation #2 | Active comparator | Dietary Supplement: Astaxanthintablets |
| Astaxanthin formulation #3 | Active comparator | Dietary Supplement: Astaxanthinpowder |
| Astaxanthin formulations | Experimental | Dietary Supplement: Astaxanthinfast condition |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects who have signed an informed consent form and who meet all of the following entrance criteria may be enrolled in this clinical trial: Generally, healthy men and women who are 21 to 50 years of age, inclusive, at the baseline visit.
Key exclusion criteria (3 listed)
- 1. Are unwilling to follow the procedures of the trial, such as making visits or having their blood drawn.
- 2. Have unintentionally lost or gained 10 or more kg of body weight in the last 3 months; 3. Have an acute illness (such as a severe cold or flu) or have been hospitalized within the past month for certain conditions; 4. Have severe co-morbid disease including cardiac, pulmonary, renal, hepatic, carotid, peripheral vascular disease, stroke, neurological, clotting disorders or active cancer; 5. Taking chronic drugs which interfere with lipids metabolism (statins or similar) 6. Consume alcohol at an elevated level (Defined as consumption of more than 10 standard alcoholic drinks per week. A standard alcoholic drink is defined as one bottle/can of beer or one glass of wine equals one portion of hard liquor).
- 7. Consume carotenoids as food supplements. 8. Have a Body Mass Index (BMI) of less than 17 or greater than 35 m/kg2; 9. Have participated in a clinical trial in the past 4 weeks; 10. Have any disease or condition that in the investigator's opinion compromises the integrity of the clinical trial or the safety of the subject; 11. Smokers 12. Pregnant woman
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 |
|---|---|---|
| Astaxanthinan oral dose form | Dietary supplement | Astaxanthin formulation #1, Astaxanthin formulation #2, Astaxanthin formulation #3, Astaxanthin formulations |
Primary outcome
plasma level
Time frame: 0-48 hr
astaxanthin in plasma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Individual participant dataSharing planned: No
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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.
Rafael Bitzur, MD principal investigator
Bert W. Strassburger Lipid Center, Sheba Medical Center, Tel Hashomer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Astaxanthin in people with Healthy Volunteers, run by Algatechnologies Ltd. at 1 site in Israel.
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 3 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 21 May 2019. 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 Israel. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
plasma level (time frame: 0-48 hr). 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 21 May 2019.