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An investigation study of the glycemic index (GI)

An investigation study of the glycemic index (GI): an open-label trial - An investigation study of the glycemic index (GI)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046166
Enrollment
10
Registered
2021-11-24
Start date
2021-11-24
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: Single dose Test food 1 [glucose loading]: OIKOS fat-free yogurt (plain/sweetened) Test food 2 [glucose loading]: OIKOS fat-free yogurt (strawberry) Test food 3 [glucose loading]: OIKOS f
Take four cups of test food 1 within 15 minutes after the fingertip micro blood sampling before glucose loading. &lt
Take four cups of test food 2 within 15 minutes after the fingertip micro blood sampling before glucose loading. &lt
Test food 3&gt
Take four cups of test food 3 within 15 minutes after the fingertip micro blood sampling before glucose loading. &lt
Take reference food within 15 minutes after the fingertip micro blood sampling before glucose loading. * The intervention sequence is reference food (before consumption and test 1
Scr), reference food (test 2), test food 1 (test 3), test food 2 (test 4), to test food 3 (test 5) and each food is single ingestion.

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 20 or more and less than 50 4. Healthy subjects 5. Subjects whose body mass index (BMI) are 30 kg/m2 or less at Scr 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose maximum concentration (Cmax) of postprandial blood glucose are 199 mg/dL or less at Scr 8. Subjects whose time to maximum concentration (Tmax) of postprandial blood glucose are 30, 45, or 60 minites at Scr 9. Subjects whose incremental area under the curve (IAUC) of postprandial blood glucose are relatively high 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 who currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 4. Subjects who have food allergies and/or food intolerances. Particularly, subjects who have lactose intolerance. 5. Subjects who have abnormal glucose tolerance 6. Subjects who take medications known to affect glucose tolerance 7. Subjects who have taken insulin therapy or antihyperglycemic medication for the treatment of diabetes. 8. Subjects who have been hospitalized for treatment or surgery within the last three months 9. Subjects who plan to have surgery within two weeks after this trial 10. Subjects who have or are undergoing medical treatment for diseases which influence digestion and absorption of nutrients 11. Subjects who are taking steroids, protease inhibitors, or antipsychotics 12. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 13. Subjects currently taking medicines (include herbal medicines) and supplements 14. Subjects who are allergic to medications and/or the test-food-related products 15. Subjects who are pregnant, breast-feeding, and planning to become pregnant 16. Subjects who suffer from COVID-19 17. 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 18. Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

MeasureTime frame
GI

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