UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032837 |
|---|---|
| Receipt number | R000037435 |
| Scientific Title | Study of the glucose metabolism-improving effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2018/08/17 |
| Last modified on | 2024/11/17 20:03:15 |
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Basic information
Public title
Study of the glucose metabolism-improving effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study
Acronym
Study of the glucose metabolism-improving effect of test food
Scientific Title
Study of the glucose metabolism-improving effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
Study of the glucose metabolism-improving effect of test food
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 improving glucose metabolism 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,III
Assessment
Primary outcomes
Fasted blood glucose, HbA1c
Key secondary outcomes
Fasted blood insulin
Insulin resistance indexes (HOMA-IR, QUICKI)
Glycoalbumin
Blood inflammatory cytokines, hsCRP
Blood adiponectin
Blood lipids
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
YES
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects giving written informed consent
2. Healthy men and women of 20 to 64 years age
3. Fasted blood glucose levels were 100 to 125 mg/dL and blood HbA1c levels were 5.6 to 6.4 % at the screening period
Key exclusion criteria
1. Subjects who take the medicine affecting blood glucose levels
2. Subjects with a habit of taking supplements or health food affecting blood glucose levels in one month before the screening test
3. Subjects with a habit of intake more than twice in a week of fermented milk or lactic fermenting beverage in one month before the screening test
4. Subjects with milk allergy
5. Subjects who were diagnosed with diabetes requiring medication by the screening test
6. Sever systemic diseases affecting the results of this study
7. Subjects who have chronic illness and who take medication everyday
8. Subjects who were judged unsuitable as subjects by clinical examination at the screening test
9. Subjects who donated blood of more than 200 mL within a month or more than 400 mL within 3 months
10. Subjects who drink a lot of alcohol
11. Subjects who have been drug dependency or alcohol dependency
12. Subjects who participated in other clinical trials within one month before the agreement of participants in this study
13. Subjects in pregnancy or in nursing
14. 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 | Satoru |
| Middle name | |
| Last name | Suzuki |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Medical examination and treatment management family chief director
Zip code
108-0075
Address
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL
81-3-3452-3381
satoru_suzuki@sempos.or.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Facility Management Department
Zip code
105-0023
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL
81-3-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
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
Ethics Committees of Nihonbashi Egawa Clinic
Address
2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel
81-3-5204-0311
jim@medipharma.co.jp
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
| 2018 | Year | 08 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/12/2/374
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/12/2/374
Number of participants that the trial has enrolled
130
Results
Reduced HbA1c levels after 12 weeks of treatment were observed in both groups compared to those at baseline; however, the 12-week reduction of HbA1c levels was significantly greater in the OLL2712 group than in the placebo group.
Results date posted
| 2024 | Year | 11 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Prediabetic adults (n = 130, age range from 20 to 64 years) were randomly assigned to either the placebo or Lactobacillus plantarum OLL2712 groups (n = 65 each)
Participant flow
A total of 1593 individuals from the volunteer bank received a screening test at the study clinic and provided written informed consent. The participants were recruited from those who personally thought that they had high blood glucose levels. However, 1333 participants were excluded in accordance with the inclusion and exclusion criteria, and 21 declined to participate owing to personal reasons. Among the remaining 239 participants, 130 were selected in descending order, first based on their FBG levels and then based on their HbA1c levels, except for those who were judged to have any disease based on clinical examinations.
Adverse events
No serious adverse events occurred in the study, although a total of 21 nonserious adverse events were accounted for through participants diaries, medical interviews, and blood tests. There were no significant differences in the incidence of adverse events between the groups, and none of these were judged by the physician in charge to be related to the consumption of the test yogurt. Regarding the blood tests, the physician judged that the changes in any parameter were within normal ranges.
Outcome measures
The primary outcome measures were changes in HbA1c and FBG levels. The secondary outcomes comprised changes in glucose metabolism-related parameters including glycoalbumin (GA), HOMA-IR, and chronic inflammation markers measured using blood, such as hsCRP and pro-inflammatory cytokine levels.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 01 | Day |
Last modified on
| 2024 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037435
