Tokyo, May 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061613) titled 'A verification study of the consumption of proanthocyanidins derived from Acacia Bark on HbA1c' on May 18.

Study Type: Interventional

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

Primary Sponsor: Institute - Acacia-No-Ki Co., Ltd.

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

Objective: Narrative objectives1 - To verify the effects of consumption of Acacia Bark extract on HbA1c. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Tablet containing proanthocyanidins derived from Acacia Bark Administration: Take six tablets before meal with water without chewing

*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. Interventions/Control_2 - Duration: 12 weeks Test product: Placebo tablet Administration: Take six tablets before meal with water without chewing

*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.

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 Subjects

5. Subjects whose HbA1c is 5.6% or more and less than 6.5% at Scr before intervention Key exclusion 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 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. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims"

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

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects whose daily alcohol intake exceeds 60 g

8. Subjects who are shift workers, such as working a late-night shift or others

9. Subjects who are pregnant, lactating, or planning to become pregnant during this trial

10. Subjects who are judged as ineligible to participate in this study by the physician Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 04 Month 22 Day Date of IRB - 2026 Year 04 Month 22 Day Anticipated trial start date - 2026 Year 05 Month 18 Day Last follow-up date - 2026 Year 12 Month 16 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070490

Disclaimer: Curated by HT Syndication.