The main ingredient of Undaria pinnatifida Sporophyll is fucoidan, rich in alginate, and contains strong antioxidant and anti-cancer active substances such as astaxanthin and fucoxanthin among β-carotene. Fucoidan is a polysaccharide of polysaccharide, a component of the cell wall of brown algae such as seaweed, which is not only effective in improving blood flow, but also in improving cancer, immuno-control, antiviral and kidney disease, and many other research results are being published in relation to various diseases. Among the prunes, the extraction yield of hukoidan is 6.6% for Undaria pinnatifida Sporophyll, 2.7% for kelp, and 2% for large yarn, and in the case of Undaria pinnatifida Sporophyll that has a high extraction yield, it is the most commonly used in the production of hukoidan in Korea.
Fucoxanthin, which is contained in seaweed, is a carotenoid-based pigment that has antioxidant function that removes it by combining with harmful free radicals, and has various other activities such as anticancer and anti-inflammatory. Undaria pinnatifida Sporophyll contain the largest amount of fuchozantine in the seaweed area, which is 1.4 times more than seaweed leaves and twice as much as seaweed stalks.
Despite the functionality of Undaria pinnatifida Sporophyll, most seaweed farms in Korea only collect foliage and throw away Undaria pinnatifida Sporophyll and seaweed stems at the sea, raising complaints about secondary damage such as marine environmental pollution and fishing boats and fisheries. Some of the Undaria pinnatifida Sporophyll is simply used for abalone feeding or eating, but due to its poor utilization and poor commercialization and industrialization, efforts are needed to make realistic industrialization.
Physiological activations and their mechanisms for immune promotion of Undaria pinnatifida Sporophyll extract (DSU02), which contains a large amount of hukoidane, were confirmed through In Vitro and In Vivo experiments. After treating the mouse macrophages RAW 264.7 cells with DSU02 at various concentrations, an analysis of the substances secreted in the culture fluid showed that the secretion of the macrophages was significantly increased and decreased in secretion of the nitric oxyide (NO) and congenital immunoactive cytokines TNF- I, IL-1α and IL-6 respectively. In addition, as a result of treating mouse spleen cells as Undaria pinnatifida Sporophyll extracts, the concentration-dependent spleen cell proliferation was observed, and the lymphocyte subpopulation analysis using flow cytometry confirmed that the ratio of CD4+T and CD8+Trimps increased significantly. At the same time, it was confirmed that the secretion of IL-4, the adaptive immuno-mmuno-cine, was increased in these cultures, and that the expression of ERK protein, an in-cell immunoactive transcription, was significantly increased. After oral administration of 50 mg/kg of Undaria pinnatifida Sporophyll extract to normal mouse, blood was collected and analyzed two weeks later, it was confirmed that the concentration of immunoactive cytokines TNF-α and IFN-γ in the blood increased significantly in the dose group compared to the control group, and the amount of antibody IgM increased significantly when oral administration increased to 150 mg/kg. In the immunosuppressive mouse model caused by Cyclophamide drug induction, blood was collected and analyzed two weeks after oral administration of the Undaria pinnatifida Sporophyll extract, significant increases in the frequency and killability of the naturally occurring cells in the 100 and 150 mg/kg groups, significant increases in the frequency of spleen-derived trimmets (CD3, 4 and 8) and CD3+, increased spleen cell growth rates, CD3, CD3. In addition, statistically significant increases in cytokines in serum TNF-α and serum immunoglobulin IgM and IgG were identified in the 150 mg/kg dose group.
Therefore, the purpose of this human application test is to confirm the validity and safety of the eight-w

 Supportive Care

Subjects are randomly allocated to either experimental or placebo group and take test materials (Undaria pinnatifida Sporophyll extract 500mg/day) or placebo twice a day, each time 1 capsule for 8 weeks.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Subject is taken test material (DSU02; Undaria pinnatifida sporophyll extract 500mg/day) by oral, twice a day, each time 1 tablet for 8 weeks.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Subject is taken placebo by oral, twice a day, each time 1 tablet for 8 weeks.

Gender

Age

Description

1) Men and women aged 20 to 75 years old
2) Peripheral blood WBC of 3×10^3/μl or more and less than 8×10^3/μl in the screening test
3) Those whose awareness of Stress Self-Assessment scale is above “strong” (4 scales: None, Moderate, Strong, Intense)
4) Those who have had upper respiratory tract infections* more than two times within one year before the start of the test
{*cough, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc}
5) A person who has agreed to participate in this test and signed a written consent form by the subject (or legal representative) voluntarily

1) Those who have been treated or are currently being treated for clinically significant acute or chronic endocrine system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal disease, psychotic, infectious diseases, etc.
2) Those who suffer from immune system disease (AIDS, autoimmune disease, systemic lupus erythematosus, sjogren's syndrome, etc.)
3) Those who suffer from severe cardiovascular diseases (stroke, hemorrhage, etc), and sever heart diseases (angina, myocardial infarction, heart failure, arrhythmia requiring treatments) or malignant tumor, etc.
4) Those with uncontrolled hypertension (160/100mmHg or more, measured after 10 minutes of rest for the subject)
5) Subjects who have got a vaccination within 3 months before screening.
6) Those whose AST(GOT) or ALT(GPT) blood level is 3 times or more than the normal upper limit of the relevant organ.
7) Those whose creatinine blood level is more than the normal upper limit.
8) Those who have consumed or are ingesting health functional foods that may affect immunity within 2 weeks before screening.
9) Those who complain of gastrointestinal symptoms such as heartburn and indigestion.
10) Those who are pregnant, lactating or planning to become pregnant during the study period.
11) Those who have participated in other studies within 3 months before screening, or plan to participate in others during this study.
12) Those who the researcher deems unsuitable for this study.
13) Those who are sensitive or allergic to test food.

Natural killer cell activity (2.5:1, 5:1, 10:1)

week 0, week 4, week 8

blood test: IFN-γ, TNF-α, IL-1β, IL-2, IL-6, IL-10, IgG, IgM (Multiplex)

week 0, week 4, week 8

White blood cell count

Screening(week -3), week 4, week 8

The degree of infection, duration, and incidence of the upper respiratory tract infection

week 0, week 4, week 8

기분상태척도

week 0, week 4, week 8

Evaluation of improvement by the test subjects themselves

week 4, week 8

Adverse events

week 4, week 8

clinical laboratory test(hematologic/chemistry examination, Urinalysis)

Screening(week -3), week 8

Vital Sign(pulsus, arteriotony) , Physical measurement (Weight)

Screening(week -3), week 0, week 4, week 8

electrocardiography

Screening(week -3), week 8