A verification study of the effects of test food consumption on postprandial blood glucose levels in healthy Japanese

A verification study of the effects of test food consumption on postprandial blood glucose levels in healthy Japanese: a randomized, placebo-controlled, double-blind, crossover comparison study - A verification study of the effects of test food consumption on postprandial blood glucose levels in healthy Japanese

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000062467

Enrollment

Registered

2026-08-04

Start date

2026-08-04

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Healthy Japanese

Interventions

&lt

Duration&gt

Single ingestion &lt

Test products&gt

Test 1: Food containing rice bran extract Test 2: Food not containing rice bran extract Load food: Bread (Pasco Shikishima Corporation), strawberry jam (Sudo Jam Co., Ltd.) &lt

Administration&gt

Test 1: Consume 10 capsules with water 30 minutes before the load food consumption. Test 2: Consume 10 capsules with water 30 minutes before the load food consumption. Load food: At screening, after

Test 1: Food not containing rice bran extract Test 2: Food containing rice bran extract Load food: Bread (Pasco Shikishima Corporation), strawberry jam (Sudo Jam Co., Ltd.) &lt

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose blood glucose level is relatively high 6. Individuals whose IAUC of GLU is relatively large at screening 7. Individuals whose BMI is relatively high

Exclusion criteria

Exclusion criteria: 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction 2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator 3. Individuals 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. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medications or foods related to the test product (particularly, rice, wheat, milk ingredients, or pork) 7. Individuals who are smokers or have not yet completed one year since quitting smoking 8. Individuals who are pregnant, lactating, or planning pregnancy during this study 9. Individuals who are deemed unsuitable for participation in this study by the principal investigator

Design outcomes

Primary

Measure	Time frame
1. Measured value of the incremental area under the curve (IAUC) of blood glucose (GLU)	—

Secondary

Measure	Time frame
1. Maximum blood concentration (Cmax) and delta-Cmax of GLU, and measured values of GLU at each assessment point (before test food consumption, and 30, 60, 90, and 120 minutes after the load) 2. Individuals who experienced adverse events 3. Systolic and diastolic blood pressure in Test 1 and Test 2	—

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: Sep 19, 2026