Overview

This trial is active, not recruiting.

Condition intrinsically labeled spirulina
Treatments spirulina ß-carotene
Phase phase 1/phase 2
Sponsor Tufts University
Collaborator Nestlé Foundation
Start date April 2004
End date March 2009
Trial size 20 participants
Trial identifier NCT00680277, PV2270

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification bio-equivalence study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
spirulina ß-carotene spirulina VA study
an acute dose of spirulina up to 5 g
spirulina ß-carotene spirulina VA study
vitamin A value of spirulina ß-carotene
(Experimental)
spirulina ß-carotene spirulina VA study
an acute dose of spirulina up to 5 g
spirulina ß-carotene spirulina VA study
vitamin A value of spirulina ß-carotene

Primary Outcomes

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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Tufts University.