Healthy adult
Conditions
Interventions
Ingestion of a fucoidan-containing food for 12 weeks.
Ingestion of placebo without a fucoidan for 12 weeks.
Sponsors
TTC Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females from 20 years of age or older to under 65 years of age 2) A lower salivary secretory immunoglobulin A secretion rate 3) POMS2-AS FI T score is more than 50 and VA T score is less than 50
Exclusion criteria
Exclusion criteria: 1) Subjects who use fucoidan-containing food or fucoidan fortified food 2) Subjects taking medicine and quasi drug (e.g., immunosuppressant, steroid) which may influence immune function 3) Subjects routinely taking health supplements which may influence immune function 4) Subjects who are under medication (e.g., hyposensitization) which may influence the outcome of the study 5) Subjects who have a history of the allergic disease 6) Subjects who have treated oral or dental care within the last one month prior to the current study or are planned to treat oral or dental care 7) Subjects who have oral or dental problems with bleeding 8) Night and day shift worker or manual laborer 9) Subjects who have carried out an intense activity (e.g., marathon race) 10) Subjects who cannot carry out a procedure of various inspection by the rule during the study period 11) Subjects who have a disease under treatment or are judged to that medical treatment are necessary by the doctor 12) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion 13) Subjects having possibilities for emerging allergy related to the study 14) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 15) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating 16) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 17) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 18) Subjects who are judged as unsuitable for the study by the investigator for other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| salivary s-IgA secretion rate | — |
Secondary
| Measure | Time frame |
|---|---|
| salivary sIgA concentration, POMS2, Fatigue VAS, PSQI-j, Intraoral questionnaire | — |
Countries
Japan
Contacts
Public ContactKunihiko Wasaki
TTC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed