UMIN ID: UMIN000028600
Registered date:10/08/2017
Evaluation of the effect of lactic acid bacteria on glucose metabolism in subjects with borderline diabetes
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Healthy volunteers |
| Date of first enrollment | 2017/10/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Intake of granulated powder containing Pediococcus pentosaceus LP28 and dextrin (2 g/day) for 12 weeks. Intake of granulated powder of dextrin (2 g/day) for 12 weeks. |
Outcome(s)
| Primary Outcome | 12-week change in OGTT-2h |
|---|---|
| Secondary Outcome | 12-week changes in AUC, Cmax and Tmax of blood glucose and insulin in OGTT, insulinogenic index, FBS, HOMA-R, HbA1c, glycoalbumin, visceral fat area, body fat percentage, abdominal circumference |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) HbA1c>=6.5% 2) Taking medicines or receiving health guidance for hypertension, diabetes, and/or hyperlipidemia 3) Taking drugs or functional food that may affect the trial 4) Participation in any clinical trial within 90 days of the commencement of the trial 5) In pregnancy or nursing a child 6) Judged as ineligible by clinical investigators |
Related Information
| Primary Sponsor | Hiroshima University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Education, Culture, Sports, Science and Technology |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Fumiko Higashikawa |
| Address | Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN Japan |
| Telephone | 082-257-1533 |
| fumiko@hiroshima-u.ac.jp | |
| Affiliation | Hiroshima University, Institute of Biomedical & Health Sciences Project Research Center for Clinical Trial and Preventive Medicine |
| scientific contact | |
| Name | Fumiko Higashikawa |
| Address | Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN Japan |
| Telephone | 082-257-1533 |
| fumiko@hiroshima-u.ac.jp | |
| Affiliation | Hiroshima University, Institute of Biomedical & Health Sciences Project Research Center for Clinical Trial and Preventive Medicine |