A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047768

Enrollment

Registered

2022-05-16

Start date

2022-04-28

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

Period I: Sennen no aojiru Period II: Placebo Carbohydrate load: Trelan-G 50 g After taking blood samples prior to the ingestion of test foods, take one pack of the test food or placebo with app

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose IAUC of postprandial blood glucose are relatively large at screening (before consumption)

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 currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. Subjects who 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, lactation, or planning to become pregnant 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 the study by the physician

Design outcomes

Primary

Measure	Time frame
1. The incremental area under the curve (IAUC) of the postprandial blood glucose	—

Secondary

Measure	Time frame
1. The maximum blood concentration (Cmax) of the postprandial blood glucose 2. The blood glucose level before consumption of the test food, at 30, 60, 90, and 120 minutes after consumption of the test food	—

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