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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030079
Receipt No. R000034276
Scientific Title The clinical trial of lactic acid bacteria in overweight adults
Date of disclosure of the study information 2017/11/22
Last modified on 2019/05/27

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Basic information
Public title The clinical trial of lactic acid bacteria in overweight adults
Acronym The clinical trial of lactic acid bacteria in overweight adults
Scientific Title The clinical trial of lactic acid bacteria in overweight adults
Scientific Title:Acronym The clinical trial of lactic acid bacteria in overweight adults
Region
Japan

Condition
Condition N/A
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effect of intake of lactic acid bacteria on lipid metabolism, health status including upper respiratory tract infection and immune function in healthy overweight adults
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes At the 0th, 4th, 8th and 12th week of the intervention
(1) Concanavalin A induced T cell proliferation
(2) Th1/Th2 ratio
Key secondary outcomes At the 0th, 4th, 8th and 12th week of the intervention
(1) C-reactive protein (CRP)
(2) Interleukin (IL)-1beta
(3) Tumor necrosis factor (TNF)-alpha
(4) Visceral fat area
(5) Questionnaire survey (POMS2 short version)
(6) Questionnaire survey (SF-36v2 standard edition)
(7) Questionnaire survey (WURSS-21 Japanese version)
(8) Blood glucose level
(9) Cholesterol level

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Oral intake of lactic acid bacteria (one tablet per day for 12 weeks)
Interventions/Control_2 Oral intake of placebo (one tablet per day for 12 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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria (1) Male and female subjects whose ages are from 20 to 75 years old
(2) Healthy subjects whose BMI values are more than 23 but less than 30
(3) Subjects who participate in this study with a written informed consent
Key exclusion criteria (1) Subjects who have symptoms of allergic rhinitis or bronchial asthma
(2) Subjects who plan to have medications that may affect the results during this clinical trial.
(3) Subjects who have consumed the lactic acid bacteria used in this clinical trial on a daily basis
(4) Subjects who are in pregnant or plan to get pregnant, or who are breastfeeding
(5) Subjects who have a history of diabetes, hepatic diseases, kidney diseases, cardiac diseases, gastrointestinal diseases, circulatory diseases or the other diseases
(6) Subjects who drink excessive alcohol or smoke heavily
(7) Subjects who are at risk of having allergic symptoms to test product of this clinical trial
(8) Subjects who have extremely irregular dietary habit, and have irregular life rhythm such as shift or midnight workers
(9) Subjects who are participating in the other clinical trial, or have participated in the other one during the past 4 weeks, or plan to enroll in the other one during scheduled period in this trial
(10) Subjects who have made a component blood donation or a blood donation of 200 mL within the last one month prior to this clinical trial
(11) Male subjects who have made a blood donation of 400 mL within the last three months prior to this clinical trial
(12) Female subjects who have made a blood donation of 400 mL within the last four months prior to this clinical trial
(13) Male subjects who have made a blood donation in amounts greater than 1,200 mL including the estimated volume of blood sampling in this clinical trial within the last one year prior to this clinical trial
(14) Female subjects who have made a blood donation in amounts greater than 800 mL including the estimated volume of blood sampling in this clinical trial within the last one year prior to this clinical trial
(15) Subjects judged as unsuitable for this clinical trial by the investigator or sub investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoshitaka
Middle name
Last name Hirose
Organization House Wellness Foods Corporation
Division name Research and Development Institute
Zip code 664-0011
Address Imoji 3-20, Itami, Hyogo
TEL 072-778-1127
Email Hirose_Yoshitaka@house-wf.co.jp

Public contact
Name of contact person
1st name Yusuke
Middle name
Last name Tanaka
Organization House Wellness Foods Corporation
Division name Research and Development Institute
Zip code 664-0011
Address Imoji 3-20, Itami, Hyogo
TEL 072-778-1127
Homepage URL
Email Tanaka_Yuusuke@house-wf.co.jp

Sponsor
Institute House Wellness Foods Corporation Research and Development Institute
Institute
Department

Funding Source
Organization House Wellness Foods Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Chiyoda Paramedical Care Clinic
Address 2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel 03-5297-5548
Email IRB@cpcc.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
2017 Year 11 Month 22 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
2017 Year 10 Month 17 Day
Date of IRB
2017 Year 09 Month 22 Day
Anticipated trial start date
2017 Year 11 Month 24 Day
Last follow-up date
2018 Year 03 Month 14 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 06 Month 13 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 22 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034276

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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