None listed
Conditions
Interventions
4 weeks).
Oral intake of the placebo food (1 capsule / day
4 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] ]Healthy Japanese males and females aged 40-64 years. [2]Individuals with borderline type or elevated postprandial blood glucose levels in glucose tolerance test (75 g OGTT) [3]Individuals who are healthy and have no chronic physical disease including skin disease. [4]Individuals whose written informed consent has been obtained. [5]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals who use or used a drug to treat a disease in the past 1 month. [2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3]Individuals whose fasting blood glucose is over 126mg/dL. [4]Individuals whose two-hour glucose level is over 200 mg/dL in glucose tolerance test. [5]Individuals whose HbA1c is over 6.5%. [6]Individuals whose BMI is less than 18.5kg/m2 or over 30kg/m2. [7]Individuals who excessively take alcohol. [8]Individuals who are a smoker. [9]Individuals who have irregular lifestyles and eating habits, and may change their lifestyles during the test period. [10]Individuals who experienced unpleasant feeling during blood drawing. [11]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [12]Individuals who ingest regularly foods for specified health uses, health foods, or foods with functional claims which may be affect the test in the past 3 months or will use or ingest those foods during the test period. [13]Individuals who may have allergic symptoms to test foods and designated meal, and Individuals who may have serious allergic symptoms to other foods. [14]Individuals who fall under any of the following criteria when using a wrist-watch device. Individuals (1) With illness or heart disease, (2) With photosensitive medication, (3) who have epilepsy or are sensitive to flashing lights, (4) with poor blood circulation or who bruise easily, (5) with tendonitis, carpal tunnel syndrome, or other musculoskeletal disorders, and (6) who may have allergic symptoms to metals. [15]Individuals who participated in other clinical studies in the past 3 months. [16]Individuals who are or are possibly pregnant, or are lactating. [17]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose level on glucose tolerance test (75g OGTT) (Screening, Week 0, Week 4:before glucose tolerance test, 30, 60, 90, and 120 minutes after glucose tolerance test). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1]Indexes for blood glucose in fasting(2). [2]Insulin on glucose tolerance test (75 OGTT)(2,5). [3]Insulinogenic Index(2). [4]Indexes for lipid in fasting(2). *Indexes for exploratory research [1]Watch-type device survey(4). [2]Questionnaire survey(3). *Safety [1]Blood pressure, pulsation(2). [2]Weight, body fat percentage, BMI(2). [3]Subject's diary(4). [4]Doctor's questions(2). [5]Adverse events: number of cases and expression rate of adverse events(3). *Other indexes [1]Hematologic test(1). [2]Blood biochemical test(1). [3]Urine analysis(1). (1):Screening. (2):Screening, Week 0, Week 4. (3):Week 0, Week 4. (4)From the first day of ingestion of a test material to the last day of the test. (5)Screening, 30, 60, 90, and 120 minutes after glucose intake. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed