Efficacy trial of single intake of plant derived ingredient. [g2018003]
- Conditions
- Adults with diabetic range of fasting glucose (fasting plasma glucose, 126-160 mg/dl)
- Registration Number
- JPRN-UMIN000032374
- Lead Sponsor
- Kao Corporation
- Brief Summary
A significant difference was observed in the primary outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 9
Not provided
(1)Subjects diagnosed with diabetes mellitus (2)Subjects taking drug related diabetes mellitus (3)Subjects who have history or symptom of cardiovascular disease or cerebrovascular disease (4)Subjects who have symptom of liver, kidney or respiratory disease, endocrine disorder, metabolic disorder, organ disorder, gout, rheumatism, autoimmune disease, allergy disease, mental disorder, cancer, infection disease, or other diseases (5)Subjects who have a history of resection of gastrointestinal tract (6)Subjects having thyroid deficiency (7)Heavy drinker (over 30g per day) (8)Subjects who have donated over 200 mL of blood within the last one month prior to the current study or over 400 mL of blood within the last three months prior to the study (9)Subjects who have severe anemia (Hb <=7g/dL) (10)Subjects who have food allergies for test foods (11)Subjects who are planned to participate in other clinical study during current study (12)Subjects who are judged to be inappropriate for the study by the medical doctor or investigator for other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose-response assessment based on concentration of gastrointestinal hormone(tAUC, iAUC, C-max).
- Secondary Outcome Measures
Name Time Method Dose-response assessment based on concentration of insulin and glucose(tAUC, iAUC, C-max).