Trials / Completed
CompletedNCT00680277
Vitamin A Value of Spirulina Carotenoids in Humans
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Tufts University · Academic / Other
- Sex
- Male
- Age
- 40 Years – 70 Years
- Healthy volunteers
- Accepted
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). 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: 1. To determine labeled ß-C blood response kinetics following an acute dose of intrinsically labeled spirulina; 2. To determine labeled retinol blood response from the intrinsically labeled spirulina; 3. To determine 13C10 retinol blood response from the isotope reference material 13C10 retinyl acetate; 4. To determine s spirulina-vitamin A equivalence.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | spirulina ß-carotene | an acute dose of spirulina up to 5 g |
| DIETARY_SUPPLEMENT | spirulina ß-carotene | vitamin A value of spirulina ß-carotene |
Timeline
- Start date
- 2004-04-01
- Primary completion
- 2008-12-31
- Completion
- 2008-12-31
- First posted
- 2008-05-20
- Last updated
- 2017-10-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00680277. Inclusion in this directory is not an endorsement.