Clinical Trials Directory

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

TypeNameDescription
DIETARY_SUPPLEMENTspirulina ß-carotenean acute dose of spirulina up to 5 g
DIETARY_SUPPLEMENTspirulina ß-carotenevitamin 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.