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A clinical study for evaluating the safety of excessive consumption of rice bran extract(glucosylceramide fraction)

A clinical study for evaluating the safety of excessive consumption of rice bran extract(glucosylceramide fraction) - A clinical study for evaluating the safety of excessive consumption of rice bran extract

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018823
Enrollment
15
Registered
2015-09-01
Start date
2015-09-03
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

not for special condition

Interventions

two capsules (10mg glucosylceramide) a day

Sponsors

NIPPON FLOUR MILLS CO.,LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)20<=age<=60 2)Male and female 3)Outpatients 4)Healthy adults 5)Those who are able to take the test food for a month 6)Those who keep daily lifestyle during the test period 7)Those who are able to consent by the document 8)Those who are not correspond to the exclusion criteria

Exclusion criteria

Exclusion criteria: 1)Those who are with a history of treatment such as myocardial infarction or heart failure 2)Exclusion for diseases (atrial fibrillation, arrhythmia, liver failure, renal failure, cerebrovascular disease, arthritis, diabetes, dyslipidemia, those being treated with high blood pressure, and other chronic diseases, etc.) 3)Who are corresponding the criteria D of the scale of health screening Society. 4)Those who take any drugs and supplements (including herbal medicine). 5)Those who are allergic (pharmaceuticals and test article-related food) 6)Those who are Pregnancy or lactation, or to be expected pregnant during the study period 7)Those who are participating in other clinical trials within a month. 8)Those who has been determined to be inappropriate of the study

Design outcomes

Primary

MeasureTime frame
the number of the adverse events which have the causal relationship between the test food observed during test period.

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co., Ltd. Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

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