Immunity Clinical Trial
| 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 |
| 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 |
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.
| 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Eulji University Hospital |
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|---|---|---|---|
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