Healthy Japanese subjects
Conditions
Interventions
Period I: Capsule containing 10-hydroxy-cis-12-octadecenoic acid (HYA) Period II: Placebo Carbohydrate load: Trelan-G 75 g After taking blood samples prior to ingesting test foods, take three act
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects whose BMI are 23 kg/m2 or more and less than 30 kg/m2
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 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 have used insulin for diabetes or taken antihyperglycemic drugs 8. Subjects who have or are undergoing medical treatment for diseases which influence digestion and absorption of nutrients 9. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 10. Subjects who currently taking medications (including herbal medicines) and supplements 11. Subjects who are allergic to medicines and/or the test food related products 12. Subjects who are pregnant, lactation, or planning to become pregnant 13. Subjects who suffer from COVID-19 14. 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 15. Subjects who are judged inappropriate as subjects from answers to lifestyle questionnaires 16. Subjects who are shift workers or late-night shift workers 17. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The incremental area under the curve (IAUC) of the postprandial blood glucagon-like peptide-1 (GLP-1) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. IAUC of peptide YY (PYY), glucose, and insulin in the postprandial blood 2. The postprandial maximum blood concentration (Cmax) of GLP-1, PYY, glucose, and insulin 3. The blood GLP-1 before consumption of the test food and 15, 30, 60, and 120 minutes after consumption of the carbohydrate load 4. The blood PYY before consumption of the test food and 15, 30, 60, and 120 minutes after consumption of the carbohydrate load 5. The blood glucose before consumption of the test food and 15, 30, 60, and 120 minutes after consumption of the carbohydrate load 6. The blood insulin before consumption of the test food and 15, 30, 60, and 120 minutes after consumption of the carbohydrate load | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed