N/A (healthy adults)
Conditions
Interventions
Test drink, containing HBF2020-02 (a single time intake)
Test drink, containing HBF2020-02 (a single time intake) ->
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Males and females aged 20-64 years old when informed consent and body mass index (BMI) is included between 18.5 to less than 30. [2] Fasting blood glucose level is from 100 to 125 mg/dL, or 75g-oral glucose tolerance test (OGTT) 2-hour after blood glucose level is less than 200 mg/dL. In addition, those who the investigator has determined to be normal high or diabetic borderline. [3] Who don't large amount of alcohol habitually. [4] Who are judged not suffering from a disease by the investigator. [5] Who can make self-judgment and voluntarily give written informed consent.
Exclusion criteria
Exclusion criteria: [1] Who use medical products affecting blood glucose. [2] Who can't stop using supplements and/or functional foods including "foods for specified health use" and/or "food with function claims" which affecting blood glucose level during the study period. [3] Who can't abstinent from alcohol from two days before each examination. [4] Who are allergic to placebo food and/or test food and/or the ingredient of high-carbohydrate diet. [5] Who are judged to be diagnosed with diabetes or carbohydrate metabolic disorders. [6] Who have a history of serious kidney damage, hepatopathy, heart disease, respiratory disease, endocrine disease, or any other metabolic disease(s) or who is under medical treatment. [7] Who have chronic disease and is under medication. [8] Who have digestive organ disease, surgical history affecting digestion and absorption of foods, or a disorder such as stenosis in the digestive tract. [9] Who are judged inappropriate for the study by the investigator. [10] Who are diagnosed as severe anemia in screening and not suitable for frequent collection of blood. [11] Who had an onset diarrhea within a week from the date of screening, and/or who are prone to diarrhea on a daily basis. [12] Who donated blood over 200mL in the past a month or over 400mL in the past 3 months from the date of informed consent. [13] Drug addict and/or alcohol addict. [14] Who are participating in other studies that using food(s), pharmaceutical(s), and cosmetic(s) now, or who have participated or are willing to participate in other studies within a month from the date of informed consent. [15] Who are or are possibly pregnant, or who are lactating, during the study period. [16] Who are judged inappropriate for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time course of blood glucose level and AUC (area under the curve) (0-120 min) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes Time course of blood insulin level and AUC (area under the curve) (0-120 min) Safety Doctor's questions | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Sales department
Outcome results
None listed