UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030079 |
|---|---|
| Receipt number | 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 09:25:18 |
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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
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
Tanaka_Yuusuke@house-wf.co.jp
Sponsor or person
Institute
House Wellness Foods Corporation Research and Development Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034276
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