Vitamin A Value of Spirulina Carotenoids in Humans
This trial is active, not recruiting.
|Condition||intrinsically labeled spirulina|
|Phase||phase 1/phase 2|
|Start date||April 2004|
|End date||March 2009|
|Trial size||20 participants|
|Trial identifier||NCT00680277, PV2270|
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.
|Endpoint classification||bio-equivalence study|
|Intervention model||single group assignment|
|Primary purpose||basic science|
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
Male participants from 40 years up to 70 years old.
Inclusion Criteria: - Healthy volunteer Exclusion Criteria: - Not has GI track problems - Any medical condition that will affect the intestinal absorption
|Official title||Vitamin A Value of Spirulina Carotenoids in Humans|
|Principal investigator||Guangwen Tang, Ph.D.|
|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.|
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