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

Effects of consumption of the test food on the blood glucose level in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on the blood glucose level in healthy Japanese subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047846

Enrollment

Registered

2022-05-24

Start date

2022-05-24

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: 12 weeks Test food: Capsule containing pentadecyl-containing auran oil Glucose load: Trelan-G 75 g Administration: &lt

Test food&gt

Take one capsule with water without chewing two times a day each after breakfast and dinner. If you don not have breakfast, take the test food in the morning. If you don not have dinner, take the tes

Glucose load&gt

Take one bottle (225 ml) within 15 minutes following the blood sampling before glucose loading. *Daily dose should be taken within the day. If you forget to take the test food, take it as soon as y

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects whose Cmax of blood glucose after glucose load are between 140 mg/dL and 199 mg/dL at screening (before consumption: Scr) 6. Subjects whose IAUC of blood glucose after glucose load are relatively large at Scr

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 disease: 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 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
The incremental area under the curve (IAUC) of the postprandial blood glucose level	—

Secondary

Measure	Time frame
1. The maximum blood concentration (Cmax) of the postprandial blood glucose 2. Blood glucose level before and 30, 60, 90, and 120 minutes after glucose load 3. The amount of change of blood glucose level between before and 30, 60, 90, and 120 minutes after glucose load 4. Insulin and 1,5-anhydroglucitol (1,5-AG), hemoglobin A1c (HbA1c), total homocysteine, pentadecanoic acid, HOMA-beta, and HOMA-IR* *HOMA-beta = (fasting blood insulin level (micro-U/mL) x 360) / (fasting blood glucose level (mg/dL) - 63) HOMA-IR = fasting blood insulin level (micro-U/mL) x fasting blood glucose level (mg/dL) / 405	—

Measure

Time frame

1. The maximum blood concentration (Cmax) of the postprandial blood glucose 2. Blood glucose level before and 30, 60, 90, and 120 minutes after glucose load 3. The amount of change of blood glucose level between before and 30, 60, 90, and 120 minutes after glucose load 4. Insulin and 1,5-anhydroglucitol (1,5-AG), hemoglobin A1c (HbA1c), total homocysteine, pentadecanoic acid, HOMA-beta, and HOMA-IR* *HOMA-beta = (fasting blood insulin level (micro-U/mL) x 360) / (fasting blood glucose level (mg/dL) - 63) HOMA-IR = fasting blood insulin level (micro-U/mL) x fasting blood glucose level (mg/dL) / 405

—

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