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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00468962
Other study ID # 07-05
Secondary ID
Status Completed
Phase Phase 4
First received May 2, 2007
Last updated May 2, 2007

Study information

Verified date May 2007
Source Eulji University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- healthy adults(the ages between 20~50 year)

Exclusion Criteria:

- food allergy and allergy skin disease

- severe liver and kidney disease

- pregnant, lactating women

- cancer, stroke, etc.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind


Related Conditions & MeSH terms


Intervention

Drug:
FACOS (functional food)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eulji University Hospital
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