UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023466 |
|---|---|
| Receipt number | R000027038 |
| Scientific Title | Study of the glucose metabolism-improving effect of the 12-week intake of beverages containing lactic acid bacteria |
| Date of disclosure of the study information | 2016/08/03 |
| Last modified on | 2018/06/01 10:06:48 |
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Basic information
Public title
Study of the glucose metabolism-improving effect of the 12-week intake of beverages containing lactic acid bacteria
Acronym
Study of the glucose metabolism-improving effect of the 12-week intake of beverages containing lactic acid bacteria
Scientific Title
Study of the glucose metabolism-improving effect of the 12-week intake of beverages containing lactic acid bacteria
Scientific Title:Acronym
Study of the glucose metabolism-improving effect of the 12-week intake of beverages containing lactic acid bacteria
Region
| Japan |
Condition
Condition
Hyperglycemia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of reducing blood glucose levels by the intake of lactic acid bacteria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Fasted blood glucose level
Glycoalbumin
Insulin resistance index
Key secondary outcomes
Blood fat level
Body fat percentage
Blood inflammatory cytokines
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12-week intake of the test food
Interventions/Control_2
12-week intake of the placebo food
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 35 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects giving written informed consent
2. Healthy men and women of 35 to 74 years age and whose fasted blood glucose levels were 110 mg/dl to 126 mg/dl at the screening period
Key exclusion criteria
1. Subjects in the drug therapy or in the hospital care
2. Sever systemic diseases affecting the results of this study
3. Subjects with an immunodeficiency
4. Subjects with a previous history or merger of malignant tumors
5. Subjects in pregnancy or in nursing
6. Subjects with a habit of intake more than twice in a week of fermented milk or lactic fermenting beverage in three months before screening test
7. Constant use of oral medication or supplements affecting glucese or lipid matabolism in three months before screening test
8. Subjects with food allergy or medicine allergy
9. Subjects who drink a lot of alcohol
10. Subjects who participated in other clinical trials within one month before the agreement of participants in this study
11. Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Matsuoka |
Organization
HUMA R&D CORP
Division name
Clinical Depelopment Division
Zip code
Address
9F RBM Hamamatsucho Build. 1-27-12 Hamamatsucho Minato-ku, Tokyo 105-0013 Japan
TEL
81-3-3431-1260
matsuoka@huma-c.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Matsuoka |
Organization
HUMA R&D CORP
Division name
Clinical Depelopment Division
Zip code
Address
9F RBM Hamamatsucho Build. 1-27-12 Hamamatsucho Minato-ku, Tokyo 105-0013 Japan
TEL
81-3-3431-1260
Homepage URL
matsuoka@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Food Microbiology Research Laboratories, Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 20 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 03 | Day |
Last modified on
| 2018 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027038
