A verification study of the suppressive effect on the elevation of blood glucose level

A verification study of the suppressive effect on the elevation of blood glucose level: a randomized, placebo-controlled, double-blind, crossover comparison trial - A verification study of the suppressive effect on the elevation of blood glucose level

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049600

Enrollment

Registered

2022-11-24

Start date

2022-11-24

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 subjects

Interventions

Duration: Single ingestion Test food: &lt

Period I&gt

Capsule containing plant extract &lt

Period II&gt

Placebo capsule &lt

Carbohydrate load (screening)&gt

75 g of glucose solution &lt

Carbohydrate load (intervention period)&gt

50 g of glucose solution Administration: &lt

Period I, II&gt

Take two capsules with water 30 minutes before carbohydrate load Duration: Single ingestion Test food: &lt

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects whose fasting blood glucose level is less than 125 mg/dL 6. Subjects whose random blood glucose level is less than 200 mg/dL

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 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 are allergic to medicines and/or the test food related products 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

Design outcomes

Primary

Measure	Time frame
1. The maximum blood concentration (Cmax) of the postprandial blood glucose level	—

Secondary

Measure	Time frame
1. The incremental area under the curve (IAUC) of the postprandial blood glucose level 2. IAUC of the blood glucose 3. The blood glucose level 15, 30, 60, and 120 minutes after consumption of the carbohydrate load	—

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