Safety evaluation of excessive ingestion of Cladosiphon okamuranus Fucoidan in healthy subjects. A Randomized, Double-blind, Placebo-controlled, Parallel Study.

Safety evaluation of excessive ingestion of Cladosiphon okamuranus Fucoidan in healthy subjects. A Randomized, Double-blind, Placebo-controlled, Parallel Study. - Safety evaluation of excessive ingestion of Cladosiphon okamuranus Fucoidan in healthy subjects.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028368

Enrollment

Registered

2017-08-01

Start date

2016-06-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No applicable

Interventions

Ingestion of 4-fold Cladosiphon okamuranus Fucoidan of recommended daily intake in test drink for 4 weeks. A placebo drink(not containing Cladosiphon okamuranus Fucoidan) intake for 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. People whose defecation frequency is no fewer than 3 nor more than 5. 2. Who usually have three meals a day. 3. Who gave the informed consents in writing after receiving enough explanation of purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.

Exclusion criteria

Exclusion criteria: People who meet any of the following conditions will be excluded. 1. Who regularly use intestinal drugs and laxative (including strong laxatives and enema) 2. Who can not stop intake the health food to relive constipation (including Food for Specified Health Uses (FOSHU)) during the screening period. 3. Who use medicine such as antibiotics that affect digestion and absorption. 4. Who can not stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relive constipation (including Food for Specified Health Uses (FOSHU)) and/or containing a large amount of sugar alcohol during the screening period. 5. Who have allergic to food. 6. Who have serious diseases requiring an urgent treatment, or who accept severe complication. 7. Who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement (except for appendicectomy). 8. Who are judged unsuitable for this study based on subject questionnaire. 9. Who is pregnant or willing to be pregnant or brest-feeding during this study. 10. Who has a current or history of drug dependence and/or alcoholism. 11. Who are participated in another clinical trial that intake/apply any of food, drug, and cosmetics, or willing to be that. 12. Who are judged unsuitable for this study by test responsibility doctor.

Design outcomes

Primary

Measure	Time frame
Safety evaluation items: Examination by a physician in charge, physical examination findings, clinical laboratory findings(Hematological test, Biochemical test, Urine test), subject symptoms at 2 weeks and 4 weeks ingestion.	—

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales Department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026