USDA Human Nutrition Research Center on Aging, Tufts Uni.
Boston, Massachusetts, 02111, United States
Completed
NCT Number: NCT00680277
Vitamin A Value of Spirulina Carotenoids in Humans
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.
Completed
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Conditions
Age range
40 year–70 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy volunteer
Exclusion criteria
- Not has GI track problems
- Any medical condition that will affect the intestinal absorption
Treatment and study plan
spirulina ß-carotene
Dietary Supplementan acute dose of spirulina up to 5 g
Other names: spirulina VA study
Primary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Tufts University
Other
Collaborators
- Nestlé Foundation
Registry information
Important dates
- Study start
- 2004
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- May 20, 2008
- Registry last updated
- Oct 12, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.