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Vitamin A Value of Spirulina Carotenoids in Humans
This study is currently recruiting participants.
Verified by Tufts University, May 2008
Sponsors and Collaborators: Tufts University
Nestle foundation
Information provided by: Tufts University
ClinicalTrials.gov Identifier: NCT00680277
  Purpose

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
Intrinsically Labeled Spirulina
Dietary Supplement: spirulina ß-carotene
Phase I
Phase II

MedlinePlus related topics: Dietary Supplements
Drug Information available for: Vitamin A Retinol Carotenoids
U.S. FDA Resources
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

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • 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 ]

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
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
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

Detailed 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.
  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:

  • Not has GI track problems
  • Any medical condition that will affect the Intestinal absorption
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680277

Contacts
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

Locations
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            
Sponsors and Collaborators
Tufts University
Nestle foundation
  More Information

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

Keywords provided by Tufts University:
spirulina
carotenoids

Study placed in the following topic categories:
Retinol palmitate
Vitamin A
Carotenoids

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins
Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009