Healthy person (high fasting blood glucose level, up to 125 mg / dl)
Conditions
Interventions
Test substance (300 mg limonite, taken every morning for 12 weeks)
Control substance (potato starch 300 mg, taken every morning for 12 weeks)
Sponsors
Mie University, Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged between 20 and 80 at the time of consent acquisition 2) Fasting blood glucose level 100-125mg / dl (not diabetes) 3) Persons who can take in foods and pharmaceuticals that affect the intestinal flora, such as lactic acid bacteria at the time of registration, can be taken continuously during the test period 4) Participants who have been given sufficient explanations and have given their informed consent with sufficient understanding after participating in this clinical trial
Exclusion criteria
Exclusion criteria: 1) HbA1c value measured during the observation period exceeded 6.5 2) Persons who do not take iron preparations or supplements or drugs intended to take iron (meaning iron 10 mg / day or heme iron more than 100 mg/day) 3) A person who is judged by the doctor to have high blood pressure based on the blood pressure measured during the observation period. (If the measured value exceeds 200 mmHg at the time of visit, the doctor who interviews and judges three times.) 4) Patients who go to the hospital regularly and need to be treated with medicines such as oral medicines (Glucose tolerance and intestinal flora are not affected and transient ones are not excluded. Example: Cold, Transient dermatitis, etc.,Exclude hospital visits due to chronic illness with or without effects) 5) Patients who are judged by the investigator or investigator to be inappropriate as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose metabolism (comparison of changes in fasting blood glucose level from the initial value at 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose metabolism (fasting blood glucose levels other than primary outcomes, HbA1c, insulin), iron (serum ferritin, serum iron, TIBC (iron binding ability)), intestinal flora (intestinal flora, defecation frequency), safety | — |
Countries
Japan
Contacts
Public ContactKoji Umeda
KSK Laboratories,Inc. representative
Outcome results
None listed