Unique ID issued by UMIN | UMIN000030344 |
---|---|
Receipt number | R000034654 |
Scientific Title | A verification study for the effects of DiBloTrig(R) ingestion on HbA1c: an open-label trial |
Date of disclosure of the study information | 2017/12/11 |
Last modified on | 2018/01/15 09:38:38 |
A verification study for the effects of DiBloTrig(R) ingestion on HbA1c: an open-label trial
A verification study for the effects of DiBloTrig(R) ingestion on HbA1c
A verification study for the effects of DiBloTrig(R) ingestion on HbA1c: an open-label trial
A verification study for the effects of DiBloTrig(R) ingestion on HbA1c
Japan |
Japanese adult people with HbA1c levels between 7.0 and 8.0% ranges
Medicine in general | Adult |
Others
NO
To verify the effects on blood HbA1c levels and others with the intake of the test food
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Hemoglobin A1c (HbA1c: NGSP)
* Compare the HbA1c levels between at the registration and 8 weeks after consuming.
HbA1c, Blood glucose level, Total cholesterol, LDL cholesterol, HDL cholesterol, Triglyceride (TG)
* For HbA1c, compare the levels between at the registration and 4 weeks after consuming. For the other outcomes, compare the levels among at the registration and 4 and 8 weeks after consuming.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
Duration: 8 weeks
Active food: DiBloTrig(R)
Administration: Take one pack of test material by dissolving it in a glass of water or warm water before each meal (before breakfast, lunch, and dinner, 3 packs per day).
* If you forget to take the active food, take it as soon as you remember within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese adult people
2. Subjects with HbA1c levels between 7.0 and 8.0% ranges
3. Subjects who are judged as eligible to participate in the study by the principal investigator
1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases
3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
4. Currently taking medicines (include herbal medicines) and supplements
5. Subjects who are allergic to medicines and/or the test food related products
6. Subjects who are pregnant, breast-feeding, and planning to become pregnant
7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
7. Subjects who are judged as ineligible to participate in the study by the principal investigator
3
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO Inc.
CEO
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
ORTHOMEDICO Inc.
Profit organization
Silk Inc.
Medical Corporation Seishinkai, Takara Clinic
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
2017 | Year | 12 | Month | 11 | Day |
Unpublished
Completed
2017 | Year | 09 | Month | 11 | Day |
2017 | Year | 10 | Month | 25 | Day |
2017 | Year | 12 | Month | 11 | Day |
2018 | Year | 01 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034654
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |