Tokyo, Nov. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059891) titled 'A study to evaluate the safety of excessive consumption of the test product: a randomized, placebo-controlled, double-blind, parallel-group comparison study' on Nov. 26.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - UCC UESHIMA COFFEE CO., LTD.

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

Objective: Narrative objectives1 - To verify the safety of consuming five times the regular daily consumption of the test product. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Duration: Four weeks Test product: Capsule containing coffee cherry pulp extract Administration: Consume five capsules per day with water.

*If you forget to take the test product, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next day. Interventions/Control_2 - Duration: Four weeks Test product: Capsule containing dextrin powder Administration: Consume five capsules per day with water.

*If you forget to take the test product, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next 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 medications (including herbal medicines) or supplements

6. Individuals who are allergic to medicines or foods related to the test product, particularly those who are allergic to coffee or have caffeine sensitivity

7. Individuals who smoke 21 or more cigarettes per day

8. Individuals whose daily alcohol intake exceeds 20 g

9. Individuals who have irregular sleeping time or habit due to work such as a late-night shift

10. Individuals who have irregular lifestyles (such as diet, exercise, and sleep)

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

12. 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

13. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 12 Day Date of IRB - 2025 Year 11 Month 12 Day Anticipated trial start date - 2025 Year 11 Month 26 Day Last follow-up date - 2026 Year 03 Month 23 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068492

Disclaimer: Curated by HT Syndication.