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

UMIN ID: UMIN000050163

Registered date:01/05/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy Japanese subjects
• Date of first enrollment: 2023/01/27
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Duration: Four weeks Test food: NutroxSunTM Administration: Take five capsules per 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 Outcome: 1. Incidence of adverse events
• Secondary Outcome: 1. 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 minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. 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 use the following medicines: antihypertensive agent, antianginal agent, antiarrhythmic agent, antilipemic agent, antiulcer drug, antibiotic, trematode infection medication, antineoplastic agent, anti-anxiety agent, immunosuppressive agent, antiallergic drug, adrenocortical hormone, hypnotics and sedatives, anti-HIV agent, thyroid hormone, antimalarial agent, analgesic agent, antiplatelet agent, vasopressin receptor antagonist, drug to prevent gout attacks, or antiasthmatic 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

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: Willfarm Co., Ltd.