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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033943
Receipt No. 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

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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
Email 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
Email suzutani@fmu.ac.jp

Sponsor
Institute Fukushima Medical University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038716

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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