NCT00468962

Brief Summary

Functional properties of chitooligosaccharides have been studied for antitumor activity, immunostimulating effects, antimicrobial activity, free radical scavening activity, adn angiotensin I converting enzyme inhibitory activity. Recent in vitro, and in vivo toxicity and absorbability studies have demonstrated that chitooligosaccharides have high absorbability and are essentially non-toxic. In the present study, we prepared a chitooligosaccharide with high absorbability and evaluated its effects on activation of immune function and cardiovascular funciton(lipid, atrial stiffness, etc) in healthy adults. This study was a 8-week, randomized, double-blind clinical trial. The 30 volunteers were divided into a control group(n=10), half dose chitooligosaccaride(FACOSTM) intake group(n=10), and full dose FACOS intake group(n=10). Peripheral blood mononuclear cells(PBMCs) were isolated and cultured in 12 well plate for 48 hours. Cytokine production by PBMCs pre- and postintervention were measured simultaneously after stimulation with lipopolysaccaride.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2007

Completed
Last Updated

May 3, 2007

Status Verified

May 1, 2007

First QC Date

May 2, 2007

Last Update Submit

May 2, 2007

Conditions

Immunity

Interventions

FACOS (functional food)DRUG

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adults(the ages between 20\~50 year)

You may not qualify if:

  • food allergy and allergy skin disease
  • severe liver and kidney disease
  • pregnant, lactating women
  • cancer, stroke, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Functional Food

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Hee-Jeong Choi, MD, Ph.D

    Eulji University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2007

First Posted

May 3, 2007

Last Updated

May 3, 2007

Record last verified: 2007-05