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Vitamin A Value of Spirulina Carotenoids in Humans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00680277
First Posted: May 20, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nestlé Foundation
Information provided by:
Tufts University
May 16, 2008
May 20, 2008
October 12, 2017
April 2004
December 31, 2008   (Final data collection date for primary outcome 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 ]
Same as current
Complete list of historical versions of study NCT00680277 on ClinicalTrials.gov Archive Site
Not Provided
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Vitamin A Value of Spirulina Carotenoids in Humans
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.

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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Intrinsically Labeled Spirulina
  • Dietary Supplement: spirulina ß-carotene
    an acute dose of spirulina up to 5 g
    Other Name: spirulina VA study
  • Dietary Supplement: spirulina ß-carotene
    vitamin A value of spirulina ß-carotene
    Other Name: spirulina VA study
  • Experimental: 1
    Interventions:
    • Dietary Supplement: spirulina ß-carotene
    • Dietary Supplement: spirulina ß-carotene
  • Experimental: 2
    Interventions:
    • Dietary Supplement: spirulina ß-carotene
    • Dietary Supplement: spirulina ß-carotene
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 31, 2008
December 31, 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:

  • Not has GI track problems
  • Any medical condition that will affect the intestinal absorption
Sexes Eligible for Study: Male
40 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00680277
PV2270
No
Not Provided
Not Provided
Guangwen Tang, Tufts University
Tufts University
Nestlé Foundation
Principal Investigator: Guangwen Tang, Ph.D. USDA Human Nutrition Research Center on Aging, Tufts University
Tufts University
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP