UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047804 |
|---|---|
| Receipt number | R000054498 |
| Scientific Title | Study of the glucose metabolism-improving effect of the 12-week intake of yogurt containing heat-treated lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2022/05/20 |
| Last modified on | 2024/11/15 16:56:32 |
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Basic information
Public title
Study of the glucose metabolism-improving effect of the 12-week intake of test 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 containing lactic acid bacteria
Scientific Title
Study of the glucose metabolism-improving effect of the 12-week intake of yogurt containing heat-treated lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
Study of the glucose metabolism-improving effect of yogurt containing heat-treated 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 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
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
Fasted blood glucose
Blood glucose after glucose loading
Glycoalbumin
Fasted blood insulin
Blood insulin after glucose loading
Insulin resistance indexes (HOMA-IR, QUICKI)
Blood 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
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. 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 or lactose intolerance
5. Subjects who were diagnosed with diabetes by the screening test
6. Subjects who have been suffering from or under treatment of 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 were collected or donated more than 200 mL of blood within a month or more than 400 mL within 3 months before the screening test
10. Subjects who drink a lot of alcohol
11. Subjects who have been drug dependency
12. Subjects who participated in other clinical trials within one month before the agreement of participants in this study
13. Subjects engaged in day/night shift work
14. Subjects who are in pregnancy, in nursing or williing to be pregnant during the test period
15. Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
81-3-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales 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
eigyou27@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
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
81-3-5641-4133
niho-jimucho@well-sleep.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
| 2022 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.15534
Publication of results
Published
Result
URL related to results and publications
https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.15534
Number of participants that the trial has enrolled
148
Results
The levels of HbA1c and glycoalbumin decreased significantly in both groups at week 12 in comparison with those at week 0, but only in the OLL2712 group at week 16. HbA1c levels decreased significantly at weeks 12 and 16 in the OLL2712 group in comparison with the placebo group (p = .014 and p = .006, respectively). No significant inter- and intragroup differences in HbA1c levels were observed at week 20.
Results date posted
| 2024 | Year | 11 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Adult participants with prediabetes [n = 148, glycated haemoglobin (HbA1c) range: 5.6%-6.4%, age range: 20-64 years] were assigned randomly to placebo or OLL2712 groups (n = 74/group)
Participant flow
In total, 1084 individuals from the volunteer bank received a screening test and provided written, informed consent. The 616 participants were excluded in accordance with the inclusion and exclusion criteria, while 27 declined to participate for personal reasons. Of the remaining 441 participants, 148 were selected in descending order based on their HbA1c and HOMA-IR levels, excluding those who were judged to have any disease based on clinical examinations.
Adverse events
The number of study participants who experienced adverse events was 29 of 74 in the placebo group and 15 of 74 in the OLL2712 group (p = .019). Typical adverse events included cold, COVID-19 infection, headache, backache, minor injury, fatigue and loose stools; one serious adverse event occurred in the placebo group, which was a hospitalization associated with a fracture during a move. None of the events were judged by the lead physician to be related to the intake of the test yogurt, indicating that no side effects occurred in this study. Regarding the blood tests, the physician judged that the changes in any parameters were within the normal range.
Outcome measures
The primary outcome measures were the 12- and 16-week changes in HbA1c levels. The secondary outcomes were changes in the levels of glycoalbumin (GA), FPG, insulin, HOMA-IR and serum cytokines.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 10 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 19 | Day |
Last modified on
| 2024 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054498
