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Vitamin A Value of Spirulina Carotenoids in Humans

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ClinicalTrials.gov Identifier: NCT00680277
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : October 12, 2017
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Intrinsically Labeled Spirulina Dietary Supplement: spirulina ß-carotene Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Vitamin A Value of Spirulina Carotenoids in Humans
Study Start Date : April 2004
Primary Completion Date : December 31, 2008
Study Completion Date : December 31, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Guangwen Tang, Tufts University
ClinicalTrials.gov Identifier: NCT00680277     History of Changes
Other Study ID Numbers: PV2270
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by Tufts University:
spirulina
carotenoids

Additional relevant MeSH terms:
Vitamins
Vitamin A
Retinol palmitate
Carotenoids
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents