Effects of consumption of the test food on postprandial blood glucose levels: a randomized, placebo-controlled, double-blind, crossover comparison study

Effects of consumption of the test food on postprandial blood glucose levels: a randomized, placebo-controlled, double-blind, crossover comparison study - Effects of consumption of the test food on postprandial blood glucose levels

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000057421

Enrollment

Registered

2025-03-27

Start date

2025-03-27

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

&lt

Duration&gt

Single ingestion &lt

Test food&gt

Test 1: Food containing dietary fiber Test 2: Food not containing dietary fiber &lt

Carbohydrate load&gt

Sato No Gohan (200 g) *The intervention sequence is test 1 to test 2. *The washout period is one week or more. &lt

Test 1: Food not containing dietary fiber Test 2: Food containing dietary fiber &lt

Sato No Gohan (200 g) *The intervention sequence is test 1 to test 2. *The washout period is one week or more.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose fasting blood glucose level is 80 mg/dL or more, and whose Cmax of postprandial blood glucose level is 140 mg/dL or more and 199 mg/dL or less at screening (Scr) 6. Individuals whose IAUC of postprandial blood glucose level is relatively large at Scr

Exclusion criteria

Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 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 have irregular lifestyles (such as diet and sleep) by night work, shift work, or others 5. Individuals who are collected blood or donated blood components either 200 mL within one month or over 400 mL within three months before the agreement to participate in this study 6. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 7. Individuals who are taking or using medications (including herbal medicines) or supplements 8. Individuals who are allergic to medicines or foods related to the test product 9. Individuals who are pregnant, lactating, or planning to become pregnant during this study 10. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 11. Individuals who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. The maximum blood concentration (Cmax), and total area under the curve (TAUC) of the blood glucose level 2. The measured values of blood glucose levels at 30, 60, 90, 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