Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects

Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, crossover trial - Effects of consumption of the test food on postprandial blood glucose in healthy Japanese subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000045341

Enrollment

Registered

2021-09-01

Start date

2021-09-03

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: Pakupakukoubokun Period II: Placebo Carbohydrate load: Rice (200 g) After taking blood samples prior to the ingestion of test foods, take two packs 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 Cmax of postprandial blood glucose are between 140 mg/dL and 199 mg/dL at screening (before consumption; Scr) 7. Subjects whose IAUC of postprandial blood glucose are relatively large at Scr

Exclusion criteria

Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 5. Subjects currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 8. 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 9. 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 eating the test food and at 30, 60, 90, and 120 minutes after eating 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