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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-UMIN000041555
Enrollment
10
Registered
2020-08-28
Start date
2020-08-31
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: Napines brown sugar 46.48 g Reference food: Trelan-G 50 g Administration: &lt
Test food &gt
After taking blood samples before intake, dissolve the test food in 200 mL of hot water and drink it. &lt
After taking blood samples before intake, drink the reference food. * The intervention sequence order is 1) reference food, 2) reference food, and 3) test food. * Washout period between each inter

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. Healthy Japanese adult subjects 2. Subjects who are 30 kg/m2 or less in BMI 3. Subjects who are judged as eligible to participate in the study by the physician

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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 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 use insulin to treat diabetes or take antihyperglycemic drugs 8. Subjects who have been hospitalized for treatment or surgery within the last three months 9. Subjects who are the presence or under the treatment of disease which influence digestion and absorption of nutrients 10. Subjects who are taking steroids, protease inhibitors, or antipsychotics 11. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 12. Currently taking medicines (include herbal medicines) and supplements 13. Subjects who are allergic to medicines and/or the test food related products 14. Subjects who are pregnant, breast-feeding, and planning to become pregnant 15. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 16. Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

MeasureTime frame
1. 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