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Vitamin A Value of Spirulina Carotenoids in Humans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Tufts University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Nestlé Foundation
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00680277
First received: May 16, 2008
Last updated: September 22, 2009
Last verified: September 2009

May 16, 2008
September 22, 2009
April 2004
March 2009   (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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00680277 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
20
May 2009
March 2009   (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
Male
40 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00680277
PV2270
No
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
September 2009

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