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
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Vitamin A Value of Spirulina Carotenoids in Humans

Resource links provided by NLM:


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: May 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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: 2 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680277

Locations
United States, Massachusetts
USDA Human Nutrition Research Center on Aging, Tufts Uni.
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Nestlé Foundation
Investigators
Principal Investigator: Guangwen Tang, Ph.D. USDA Human Nutrition Research Center on Aging, Tufts University
  More Information

No publications provided

Responsible Party: Guangwen Tang, Tufts University
ClinicalTrials.gov Identifier: NCT00680277     History of Changes
Other Study ID Numbers: PV2270
Study First Received: May 16, 2008
Last Updated: September 22, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
spirulina
carotenoids

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

ClinicalTrials.gov processed this record on October 19, 2014