UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022842 |
|---|---|
| Receipt number | R000026326 |
| Scientific Title | Confirmation trial for body fat-reducing effect of a beverage containing the lactic acid bacterial strain CP1563 - A randomized, double-blind, placebo-controlled parallel group trial - |
| Date of disclosure of the study information | 2016/06/24 |
| Last modified on | 2017/12/25 10:55:49 |
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Basic information
Public title
Confirmation trial for body fat-reducing effect of a beverage containing the lactic acid bacterial strain CP1563 - A randomized, double-blind, placebo-controlled parallel group trial -
Acronym
Trial for body fat-reducing effect of CP1563
Scientific Title
Confirmation trial for body fat-reducing effect of a beverage containing the lactic acid bacterial strain CP1563 - A randomized, double-blind, placebo-controlled parallel group trial -
Scientific Title:Acronym
Trial for body fat-reducing effect of CP1563
Region
| Japan |
Condition
Condition
Healthy adults with BMI values over 23 but less than 30
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of a lactic beverage containing CP1563 on the reduction of body fat, visceral fat and subcutaneous fat
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the effects of a beverage containing CP1563 on fat area determined by CT through the 18-week intervention period
Key secondary outcomes
Evaluate the effects of a beverage containing CP1563 on lipid and sugar metabolisms through the 18-week intervention period
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
Daily intakes of a beverage containing CP1563 for 18 weeks
Interventions/Control_2
Daily intakes of a beverage without CP1563 for 18 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects whose BMI values are over 23 but less than 30 (subjects of high normal and obesity class I)
2. Subjects whose visceral fat area is around 100 cm2
Key exclusion criteria
1. Persons who take drugs for adiposity, hypertension and dyslipidemia
2. Persons who cannot give up the intake of possible supplements which may affect the status of fat, blood pressure and plasma lipids
3. Persons who cannot terminate the consumption of foods containing large number of lactic acid bacteria during the trial
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mamoru Oki |
Organization
Incorporated Medical Association Seishukai
Division name
Seishukai Clinic
Zip code
Address
3-18-5 Matsugatani, Taito-ku, Tokyo
TEL
03-3847-8866
mamoru.oki@seishukai.clinic.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshika Komori |
Organization
KSO Co., Ltd
Division name
Chairperson
Zip code
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
Asahi Group Holdings, Ltd
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Holdings, Ltd
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
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
| 2016 | Year | 06 | Month | 24 | 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
As results of having analyzed the data obtained in the trial using an analysis of covariance for repeated measures, significant differences in both total body fat and visceral fat areas between both groups were recognized.
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 29 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 17 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 10 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 31 | Day |
Other
Other related information
In the stratified analyses using an analysis of covariance for repeated measures, significant differences in both total body fat and visceral fat areas between both groups were also recognized.in subjects who have the initial visceral fat area less than 100cm2.
Management information
Registered date
| 2016 | Year | 06 | Month | 22 | Day |
Last modified on
| 2017 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026326
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/12/25 | CPS-008-01試験実施計画書20160620.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
