A study for evaluating the immune response by ingestion of a fucoidan-containing food in adult males and females : a randomized, double blind, placebo-controlled, parallel-group trial

Not Applicable

• Conditions: Healthy adult

• Registration Number: JPRN-UMIN000024995
• Lead Sponsor: TTC Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified