diabetes
Conditions
Interventions
20.4 g/day for 8 weeks as a replacement for snack between meals
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Fasting blood glucose level more than(>=)100 mg/dL 2) HbA1c(NGSP)level between(>=) 5.6% to (<)6.9% 3) Fasting serum triglyceride level (>=)100 mg/dL 4) BMI level more than(>=) 25 kg/square meter 5) Nonsmoker 6) Subject, upon briefing of the content of the present study, fully understands and agrees to its objective and is able to personally give written informed consent
Exclusion criteria
Exclusion criteria: 1) Subject taking any diabetes treatment(pharmacotherapy, diet therapy, exercise therapy etc) 2) Subject regularly taking any FOSHU or health food which is capable of improving blood glucose level 3) Subject having no habit of having a snack between meals 4) Subject who ended participation in another clinical trial less than 3 months before and who is currently involved in another clinical trial 5) For female subjects: pregnancy or possibility of pregnancy, or intending to become pregnant during this clinical trial 6) Subject who should have diabetes treatment by the investigator's judgement 7) Subject having a possibility to cause allergy symptoms(especially allergy to soybean) related to clinical test 8) Subject determined unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose, HbA1c and insulin level at each visit (-4W, 0W, 4W, 8W) | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood triglyceride level, BMI and body component analysis at each visit (-4W, 0W, 4W, 8W) | — |
Countries
Japan
Contacts
Public ContactSugino Tomohiro
Soiken Inc. R&D Division
Outcome results
None listed