Vitamin A Value of Spirulina Carotenoids in Humans

NCT ID: NCT00680277

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Intrinsically Labeled Spirulina

Keywords

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spirulina carotenoids

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

spirulina ß-carotene

Intervention Type DIETARY_SUPPLEMENT

an acute dose of spirulina up to 5 g

spirulina ß-carotene

Intervention Type DIETARY_SUPPLEMENT

vitamin A value of spirulina ß-carotene

2

Group Type EXPERIMENTAL

spirulina ß-carotene

Intervention Type DIETARY_SUPPLEMENT

an acute dose of spirulina up to 5 g

spirulina ß-carotene

Intervention Type DIETARY_SUPPLEMENT

vitamin A value of spirulina ß-carotene

Interventions

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spirulina ß-carotene

an acute dose of spirulina up to 5 g

Intervention Type DIETARY_SUPPLEMENT

spirulina ß-carotene

vitamin A value of spirulina ß-carotene

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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spirulina VA study spirulina VA study

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteer

Exclusion Criteria

* Not has GI track problems
* Any medical condition that will affect the intestinal absorption
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nestlé Foundation

OTHER

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Tufts University

Principal Investigators

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Guangwen Tang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

USDA Human Nutrition Research Center on Aging, Tufts University

Locations

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USDA Human Nutrition Research Center on Aging, Tufts Uni.

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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PV2270

Identifier Type: -

Identifier Source: org_study_id