A verification study of the blood glucose response

A verification study of the blood glucose response: a randomized, placebo-controlled, double-blind, crossover comparison trial - A verification study of the blood glucose response

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000052111

Enrollment

Registered

2023-09-28

Start date

2023-09-05

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

&lt

Duration&gt

Single ingestion &lt

Test food&gt

Period I: Test saccharides Period II: Maltodextrin Carbohydrate load at screening (before consumption

Scr): Maltodextrin &lt

Administration&gt

Test saccharides: 51.8 g (50.0 g as solid) Maltodextrin: 52.0 g (50.0 g as solid) Carbohydrate load at Scr: Maltodextrin 52.0 g (50.0 g as solid) *Washout period is one week or more &lt

Period I: Maltodextrin Period II: Test saccharides Carbohydrate load at Scr: Maltodextrin &lt

Maltodextrin: 52.0 g (50.0 g as solid) Test saccharides: 51.8 g (50.0 g as solid) Carbohydrate load at Scr: Maltodextrin 52.0 g (50.0 g as solid) *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 subjects 5. Subjects whose fasting blood glucose level is 125 mg/dL or less at Scr 6. Subjects whose blood glucose level is less than 200 mg/dL after consuming carbohydrate load at Scr 7. Subjects whose time to Cmax of glucose is 30 or 60 minutes 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 diseases: 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 are 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, lactating, or planning to become pregnant during this trial 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 this study by the physician

Design outcomes

Primary

Measure	Time frame
1. The blood glucose level and the blood insulin level before and 30, 60, 90, and 120 minutes after consumption of the test food	—

Secondary

Measure	Time frame
1. The maximum blood concentration (Cmax) of the glucose after consumption of the test food 2. The incremental area under the curve (IAUC) of the blood glucose 3. The IAUC and Cmax of the blood insulin	—

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