Healthy Japanese
Conditions
Interventions
<
Duration>
Single ingestion (three times) <
Test 1: Green rooibos HCP active capsule + Green rooibos HCP placebo capsule Test 2: Green rooibos HCP active capsule Test 3: Green rooibos HCP placebo capsule <
Trelan(R) G 75 g <
Test 1: Four capsules per intake (2 green rooibos HCP active capsules + 2 green rooibos HCP placebo capsules) Test 2: Four capsules per intake (4 green rooibos HCP active capsules) Test 3: Four caps
Test 1: Green rooibos HCP active capsules Test 2: Green rooibos HCP placebo capsules Test 3: Green rooibos HCP active capsules + Green rooibos HCP placebo capsules <
Test 1: Four capsules per intake (4 green rooibos HCP active capsules) Test 2: Four capsules per intake (green rooibos HCP placebo capsules) Test 3: Four capsules per intake (2 green rooibos HCP act
Sponsors
Nikken Foods Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged >=40 and <=64 years 4. Healthy individuals 5. Individuals whose fasting blood glucose level is <=125 mg/dL and whose 2-hour blood glucose level during a 75 g OGTT is <=199 mg/dL 6. Individuals whose Cmax of blood glucose following a 75 g OGTT is >=140 mg/dL and <=199 mg/dL 7. Individuals whose IAUC for blood glucose during a 75 g OGTT load at screening is relatively high 8. Individuals whose BMI is >=18.5 kg/m2 and <30 kg/m2
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) or supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals who are smokers or have not yet completed one year since quitting smoking 8. Individuals who are pregnant, lactating, or planning to become pregnant during this study 9. Individuals who have participated in other clinical studies within 28 days before informed consent, 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. The incremental area under the curve (IAUC) for glucose (GLU) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The maximum blood concentration (Cmax) of GLU, and the measured values of GLU at each time point (before and 30, 60, 90, and 120 minutes after the load) and their changes from before the load 2. The IAUC and Cmax of insulin, and the measured values of insulin at each time point (before and 30, 60, 90, and 120 minutes after the load) and their changes from before the load 3. Individuals who experienced adverse events 4. Systolic and diastolic blood pressure in Test 1, Test 2, and Test 3 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed