A study of the suppressive effects of the test food on the elevation of postprandial blood glucose levels: a randomized, placebo-controlled, double-blind, crossover comparison study

A study of the suppressive effects of the test food on the elevation of postprandial blood glucose levels: a randomized, placebo-controlled, double-blind, crossover comparison study - A study of the suppressive effects of the test food on the elevation of postprandial blood glucose levels

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000055544

Enrollment

Registered

2024-09-19

Start date

2024-09-19

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

Duration: Single ingestion Test food: &lt

Test 1&gt

Active food &lt

Test 2&gt

Placebo food *The intervention sequence is Test 1 to Test 2. *Washout period is for one week or more. Duration: Single ingestion Test food: &lt

Placebo food &lt

Active food *The intervention sequence is Test 1 to Test 2. *Washout period is for 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 less than 126 mg/dL at screening (before consumption; Scr) 6. Individuals whose blood glucose level at 120 minutes after consumption of a carbohydrate load (Trelan-G 75 g) is less than 200 mg/dL, and whose maximum blood concentration (Cmax) of the glucose after consumption of a carbohydrate load (Trelan-G 75 g) is 140 mg/dL or more at Scr 7. Individuals whose incremental area under the curve (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 are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and foods related to the test product 7. Individuals who donated blood within the last two months before the agreement to participate in this study 8. Individuals who are pregnant, lactating, or planning to become pregnant during this study 9. Individuals who have been enrolled in other clinical studies within the last three months before the agreement to participate in this study or plan to participate in another study during this study 10. Individuals who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

Measure	Time frame
1. Postprandial blood glucose levels	—

Secondary

Measure	Time frame
1. Postprandial blood insulin levels	—

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