A verification study of the consumption of proanthocyanidins derived from Acacia Bark on HbA1c

A verification study of the consumption of proanthocyanidins derived from Acacia Bark on HbA1c: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A verification study of the consumption of proanthocyanidins derived from Acacia Bark on HbA1c

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061613

Enrollment

Registered

2026-05-18

Start date

2026-05-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese

Interventions

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 te

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. The measured value of hemoglobin A1c (HbA1c: NGSP) at 12 weeks after intervention (12w)	—

Secondary

Measure	Time frame
1. The measured values of glucose (GLU), insulin (IRI), and homeostasis model assessment of insulin resistance (HOMA-IR) at 12w 2. The logarithmic values of hemoglobin A1c (HbA1c: NGSP), glucose (GLU), insulin (IRI), and HOMA-IR at 12w 3. Subjects who experienced adverse events 4. Subjects whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening (Scr) 5. Physical measurements, urinalysis, and peripheral blood test	—

Measure

Time frame

1. The measured values of glucose (GLU), insulin (IRI), and homeostasis model assessment of insulin resistance (HOMA-IR) at 12w 2. The logarithmic values of hemoglobin A1c (HbA1c: NGSP), glucose (GLU), insulin (IRI), and HOMA-IR at 12w 3. Subjects who experienced adverse events 4. Subjects whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening (Scr) 5. Physical measurements, urinalysis, and peripheral blood test

—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026