Tokyo, Oct. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059547) titled 'A study to evaluate the safety of excessive consumption of blue rose extract powder' on Oct. 27.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - KINJIRUSHI Co., LTD.

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the safety of excessive consumption of blue rose extract powder. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Duration: 4weeks Test product: Aurum Blue(R) Rose Ex M (KRE-101) (500 mg/day) Administration: Consume two capsules with water at any time once daily.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Adults

4. Healthy individuals Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking or using medicines (including herbal medicines) or supplements

6. Individuals who are allergic to medicines or foods related to the test product (particularly, Rosaceae plants such as apples, peaches, or Japanese pears)

7. Individuals who are pregnant, lactating, or planning to become pregnant during this study

8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

9. Individuals who are undergoing dietary or exercise therapy under medical supervision

10. Individuals who are unable to abstain from alcohol on the day before the examination

11. Individuals who have a current or past history of drug or alcohol dependence

12. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 10

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 08 Day Date of IRB - 2025 Year 10 Month 08 Day Anticipated trial start date - 2025 Year 10 Month 27 Day Last follow-up date - 2026 Year 02 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068112

Disclaimer: Curated by HT Syndication.