Healthy subjects
Conditions
Interventions
Continuous intake of the test food for 2 weeks.
Continuous intake of the placebo food for 2 weeks.
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese males and females who are aged 20 years or over and less than 65 at the time of obtaining informed consent. 2.Subjects with HbA1c less than 6.5% in the subject panel data. 3.Subjects with fasting blood glucose less than 126 mg/dL in the subject panel data. 4.Subjects with 120-minute glucose value less than 200 mg/dL as a result of a 75 g oral glucose tolerance test (OGTT) in the subject panel data. 5.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects diagnosed with diabetes mellitus by a physician. 2.Subjects receiving medication or outpatient treatment for a serious disease. 3.Subjects receiving exercise or diet therapy under the supervision of a physician. 4.Subjects who are at risk of developing allergies to the test food or the load food. 5.Subjects with current or previous history of drug dependence or alcohol dependence. 6.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder. 7.Night or shift workers with irregular life patterns. 8.Subjects whose eating, sleeping, and other habits are extremely irregular. 9.Subjects who are having a very unbalanced diet. 10.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more) or excessive smokers (21 cigarettes/day or more). 11.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases. 12.Subjects who routinely use or cannot refrain from using health food, supplements, and medications that affect blood glucose levels. 13.Subjects who routinely use or cannot refrain from using health food, supplements, and medications claiming to contain dietary fiber. 14.Subjects with alcohol hypersensitivity which makes alcohol disinfection difficult. 15.Subjects who have difficulty in blood sampling from a finger tip. 16.Subjects who participated in another clinical study within 2 months before the beginning of test food intakes or who plan to participate in another clinical study during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inhibitory effect on postprandial blood glucose elevation | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) life questionnaire (Safety evaluation) Vital signs, physical measurements (body weight and BMI), adverse events | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed