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Sponsors and Collaborators: |
Tufts University Nestle foundation |
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Information provided by: | Tufts University |
ClinicalTrials.gov Identifier: | NCT00680277 |
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.
Condition | Intervention | Phase |
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Intrinsically Labeled Spirulina |
Dietary Supplement: spirulina ß-carotene |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Bio-equivalence Study |
Official Title: | Vitamin A Value of Spirulina Carotenoids in Humans |
Estimated Enrollment: | 20 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
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
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2: Experimental |
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
|
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:
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Guangwen Tang, Ph.D | 617-556-3236 | Guangwen.tang@tufts.edu |
Contact: Robert M Russell, Ph. D | 617-556-3335 | rob.russell@tufts.edu |
United States, Massachusetts | |
USDA Human Nutrition Research Center on Aging, Tufts Uni. | Recruiting |
Boston, Massachusetts, United States, 02111 | |
Contact: Guangwen Tang, Ph. D 617-556-3236 Guangwen.tang@tufts.edu | |
Principal Investigator: Guangwen Tang, Ph.D |
Responsible Party: | Tufts University ( Guangwen Tang ) |
Study ID Numbers: | PV2270 |
Study First Received: | May 16, 2008 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00680277 |
Health Authority: | United States: Institutional Review Board |
spirulina carotenoids |
Retinol palmitate Vitamin A Carotenoids |
Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions |