NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000048785

Registered date:30/11/2023

A study to evaluate the safety of excessive consumption of the test food in human

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedHealthy Japanese subjects
Date of first enrollment2022/08/29
Target sample size10
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Duration: Four weeks Test food: METABOLAID(R) Administration: Take ten capsules with water without chewing once a day *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Outcome(s)

Primary Outcome1. Incidence of adverse events
Secondary Outcome1. The proportion of subjects whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before consumption; Scr)

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in this study by the physician

Related Information

Contact

public contact
Name Naoko Suzuki
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan. Japan 112-0002
Telephone 03-3818-0610
E-mail nao@orthomedico.jp
Affiliation ORTHOMEDICO Inc. R&D Department
scientific contact
Name Tsuyoshi Takara
Address 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan Japan
Telephone 03-5793-3623
E-mail t-takara@takara-clinic.com
Affiliation Medical Corporation Seishinkai, Takara Clinic Director