Intrinsically Labeled SpirulinaPhase 1/2NCT00680277
Vitamin A Value of Spirulina Carotenoids in Humans
A Phase 1/2 study testing spirulina ß-carotene in people with Intrinsically Labeled Spirulina, run by Tufts University at 1 site in United States.
Trial summary
The goal of this protocol is to determine the vitamin A value (equivalence) of spirulina. The investigation will use intrinsically deuterium labeled spirulina and an isotope vitamin A reference dose, 13C10- retinyl acetate (13C10 RAc), in males (n=20). Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Intrinsically Labeled Spirulina
- What is being tested?
- spirulina ß-carotene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to 31 Dec 2008
- Phase
- Phase 1/2
- 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 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer
Who cannot join
- Not has GI track problems
- Any medical condition that will affect the intestinal absorption
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Human Nutrition Research Center on Aging, Tufts Uni.
Boston, Massachusetts, 02111
About this study
The goal of this protocol is to determine the vitamin A value (equivalence) of spirulina. The investigation will use intrinsically deuterium labeled spirulina and an isotope vitamin A reference dose, 13C10- retinyl acetate (13C10 RAc), in males (n=20). Up to 45 blood samples (10 ml/sample) will be collected from each subject over a two-month period to evaluate the bioavailability and bioconversion of spirulina ß-carotene to vitamin A.
Read the detailed description
By utilizing novel stable isotope dilution techniques recently developed in our laboratory, we will trace deuterium labeled ß-carotene in intrinsically labeled spirulina, which is harvested from a hydroponic system. In the mean time, we will track 13C10 labeled vitamin A in humans. In this way we will determine absorption of ß-carotene from spirulina matrix and the conversion of the spirulina ß-Carotene to retinol. This will enable us quantitatively determine the vitamin A equivalence of spirulina.
The specific aims of this study are:
- To determine labeled ß-C blood response kinetics following an acute dose of intrinsically labeled spirulina;
- To determine labeled retinol blood response from the intrinsically labeled spirulina;
- To determine 13C10 retinol blood response from the isotope reference material 13C10 retinyl acetate;
- To determine s spirulina-vitamin A equivalence.
- Conditions
- Intrinsically Labeled Spirulina
- Being tested
- spirulina ß-carotene
- Keywords
- spirulina, carotenoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirulina ß-caroteneDietary supplement
Also called spirulina VA study
an acute dose of spirulina up to 5 g
spirulina ß-caroteneDietary supplement
Also called spirulina VA study
vitamin A value of spirulina ß-carotene
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: spirulina ß-carotene |
| 2 | Experimental | Not described Receives: Dietary Supplement: spirulina ß-carotene |
What is being measured
The primary outcome is the main question the study is designed to answer.
The enrichment of spirulina ß-carotene and its cleavage product vitamin A were tracked after taken the oral dose of intrinsically labeled spirulina.
Measured: 51 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startApr 2004
- Primary completion31 Dec 2008
- Study completion31 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrinsically Labeled SpirulinaStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Foundation
- Investigators
- Guangwen Tang, Ph.D., Principal investigator, USDA Human Nutrition Research Center on Aging, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680277
- Sponsor's protocol ID
- PV2270
- Status last verified
- Oct 2017
- First submitted
- 16 May 2008
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin A Value of Spirulina Carotenoids in Humans
- ClinicalTrials.gov ID
- NCT00680277
- Acronym / sponsor ID
- PV2270
- Conditions
- Intrinsically Labeled Spirulina
- Keywords
- spirulina, carotenoids
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Nestlé Foundation
- Study start
- Apr 2004
- Primary completion
- 31 Dec 2008 (actual)
- Study completion
- 31 Dec 2008 (actual)
- First posted
- 20 May 2008 (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 goal of this protocol is to determine the vitamin A value (equivalence) of spirulina. The investigation will use intrinsically deuterium labeled spirulina and an isotope vitamin A reference dose, 13C10- retinyl acetate (13C10 RAc), in males (n=20). Up to 45 blood samples (10 ml/sample) will be collected from each subject over a two-month period to evaluate the bioavailability and bioconversion of spirulina ß-carotene to vitamin A.
Detailed description
By utilizing novel stable isotope dilution techniques recently developed in our laboratory, we will trace deuterium labeled ß-carotene in intrinsically labeled spirulina, which is harvested from a hydroponic system. In the mean time, we will track 13C10 labeled vitamin A in humans. In this way we will determine absorption of ß-carotene from spirulina matrix and the conversion of the spirulina ß-Carotene to retinol. This will enable us quantitatively determine the vitamin A equivalence of spirulina.
The specific aims of this study are:
- To determine labeled ß-C blood response kinetics following an acute dose of intrinsically labeled spirulina;
- To determine labeled retinol blood response from the intrinsically labeled spirulina;
- To determine 13C10 retinol blood response from the isotope reference material 13C10 retinyl acetate;
- To determine s spirulina-vitamin A equivalence.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: spirulina ß-carotene |
| 2 | Experimental | Dietary Supplement: spirulina ß-carotene |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteer
Key exclusion criteria (2 listed)
- Not has GI track problems
- Any medical condition that will affect the intestinal absorption
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 |
|---|---|---|
| spirulina ß-caroteneAlso: spirulina VA studyan acute dose of spirulina up to 5 g | Dietary supplement | 1, 2 |
| spirulina ß-caroteneAlso: spirulina VA studyvitamin A value of spirulina ß-carotene | Dietary supplement | 1, 2 |
Primary outcome
The enrichment of spirulina ß-carotene and its cleavage product vitamin A were tracked after taken the oral dose of intrinsically labeled spirulina.
Time frame: 51 days
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 12 Oct 2017.
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.
Guangwen Tang, Ph.D. principal investigator
USDA Human Nutrition Research Center on Aging, Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing spirulina ß-carotene in people with Intrinsically Labeled Spirulina, run by Tufts University at 1 site in United States.
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 2 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 12 Oct 2017. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The enrichment of spirulina ß-carotene and its cleavage product vitamin A were tracked after taken the oral dose of intrinsically labeled spirulina. (time frame: 51 days). 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 12 Oct 2017.