Vitamin A Value of Spirulina Carotenoids in Humans

Phase 1

Completed

• Conditions: Intrinsically Labeled Spirulina
• Interventions: Dietary Supplement: spirulina ß-carotene

• Registration Number: NCT00680277
• Lead Sponsor: Tufts University

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.

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 Timeline

• Study Start: 2004-04
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-20
• Primary Completion: 2008-12-31
• Study Completion: 2008-12-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Healthy volunteer

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Exclusion Criteria

• Not has GI track problems
• Any medical condition that will affect the intestinal absorption

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	spirulina ß-carotene	-
1	spirulina ß-carotene	-

Primary Outcome Measures

Name	Time	Method
The enrichment of spirulina ß-carotene and its cleavage product vitamin A were tracked after taken the oral dose of intrinsically labeled spirulina.	51 days

Trial Locations

Locations (1)

USDA Human Nutrition Research Center on Aging, Tufts Uni.; 🇺🇸 Boston, Massachusetts, United States