UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033943 |
|---|---|
| Receipt number | R000038716 |
| Scientific Title | Study of lactic acid bacteria (Lactococcus lactis 11/19-B1 strain and Bifidobacterium lactis ) on bowel movement, and blood glucose and cholesterol levels. |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2018/08/29 17:16:31 |
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Basic information
Public title
Study of lactic acid bacteria (Lactococcus lactis 11/19-B1 strain and Bifidobacterium lactis ) on bowel movement, and blood glucose and cholesterol levels.
Acronym
Study of lactic acid bacteria (Lactococcus lactis 11/19-B1 strain and Bifidobacterium lactis ) on bowel movement, and blood glucose and cholesterol levels.
Scientific Title
Study of lactic acid bacteria (Lactococcus lactis 11/19-B1 strain and Bifidobacterium lactis ) on bowel movement, and blood glucose and cholesterol levels.
Scientific Title:Acronym
Study of lactic acid bacteria (Lactococcus lactis 11/19-B1 strain and Bifidobacterium lactis ) on bowel movement, and blood glucose and cholesterol levels.
Region
| Japan |
Condition
Condition
Mild constipation, hyperglycemia and hypercholesterolemia
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify whether the intake of yogurt enriched with Lactococcus lactis 11/19-B1 strain and Bifidobacterium lactis improves bowel movement, blood glucose level and serum cholesterol level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of days with bowel movement during observation period, fasting blood glucose level and serum cholesterol level
Key secondary outcomes
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of 80g of the control yogurt per day for 8 weeks.
Interventions/Control_2
Ingestion of 80g of the test yogurt per day for 8 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A person who fits one of the following conditions:
1) bowel movements less than once every 2 days
2) fasting blood sugar has been found to be relatively high
3) serum cholesterol level has been found to be relatively high
Key exclusion criteria
A person receiving treatment for the above-mentioned abnormalities
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Suzutani |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Microbiology
Zip code
Address
1 Hikarigaoka, Fukushima 960-1295
TEL
024-547-1158
suzutani@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Suzutani |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Microbiology
Zip code
Address
1 Hikarigaoka, Fukushima 960-1295
TEL
024-547-1158
Homepage URL
https://www.fmu.ac.jp
suzutani@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukushima prefacture
Nonprofit foundation
Tohoku Kyodo Milk Co. Ltd.
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tohoku Kyodo Milk Co., Ltd.
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
| 2018 | Year | 10 | Month | 01 | 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
Ingestion of control yogurt had no effect on serum LDL values but the yogurt enriched with Lactococcus lactis 11/19-B1 strain and Bifidobacterium lactis significantly decreased serum LDL values. This effect was observed in the group with high serum LDL values (>120mg/dl), but no effect was observed in the group with normal serum LDL values. Neither the control nor enriched test yogurt had any effect on blood sugar level or bowel movement.
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 | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 29 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 29 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 29 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 29 | Day |
Last modified on
| 2018 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038716
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
