NCT00680277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2008

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

4.8 years

First QC Date

May 16, 2008

Last Update Submit

October 11, 2017

Conditions

Intrinsically Labeled Spirulina

Keywords

spirulinacarotenoids

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: spirulina ß-carotene

2

EXPERIMENTAL
Dietary Supplement: spirulina ß-carotene

Interventions

spirulina ß-caroteneDIETARY_SUPPLEMENT

an acute dose of spirulina up to 5 g

Also known as: spirulina VA study
12

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Human Nutrition Research Center on Aging, Tufts Uni.

Boston, Massachusetts, 02111, United States

Location

Study Officials

  • Guangwen Tang, Ph.D.

    USDA Human Nutrition Research Center on Aging, Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 20, 2008

Study Start

April 1, 2004

Primary Completion

December 31, 2008

Study Completion

December 31, 2008

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

US(1)