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Safety evaluation of excessive intake of food containing fucose.

A randomized, double-blind, placebo-controlled, parallel-group study on the safety evaluation of excessive intake of food containing fucose. - Safety evaluation of excessive intake of food containing fucose.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043095
Enrollment
20
Registered
2021-01-23
Start date
2021-01-25
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

None listed

Interventions

Intake of food containing fucose for 4 weeks. Intake of placebo without fucose for 4 weeks.

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy males and females aged 20 to 64 years old 2. Subjects who are between 23 kg/m2 or more and less than 30 kg/m2 in BMI 3. Subjects who can make self-judgment and are voluntarily giving written informed consent

Exclusion criteria

Exclusion criteria: 1. Subjects who use medications affecting obesity, hyperlipidemia and lipid metabolism 2. Subjects who cannot stop using supplements and/or functional foods affecting obesity, hyperlipidemia and lipid metabolism 3. Subjects who are under treatment or have a history of disease e.g., serious liver disease, heart disease, respiratory insufficiency, endocrine disorder, metabolic diseases or food allergy 4. Subjects who have under treatment or a history of drug addiction and/or alcoholism 5. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 6. Subjects who have been diagnosed as familial hyperlipidemia 7. Subjects who has food allergy. 8. Subjects who are participating or planning to participate in other clinical studies to examine effects of food, medicine or cosmetics 9. Subjects who are planning to become pregnant during the study or are pregnant or lactating 10. Subjects who are judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Hematologic test Biochemistry test Urinalysis Blood pressure/pulse Weight/body mass index Medical interview Adverse event and side effect

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