UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041194 |
|---|---|
| Receipt number | R000047035 |
| Scientific Title | A study for the effect of intake of lactic acid bacteria on visceral fat, body fat, abdominal CT visual analysis |
| Date of disclosure of the study information | 2021/11/29 |
| Last modified on | 2021/01/06 16:17:46 |
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Basic information
Public title
A study for the effect of intake of lactic acid bacteria on visceral fat, body fat, abdominal CT visual analysis
Acronym
A study for the effect of intake of lactic acid bacteria on visceral fat, body fat, abdominal CT visual analysis
Scientific Title
A study for the effect of intake of lactic acid bacteria on visceral fat, body fat, abdominal CT visual analysis
Scientific Title:Acronym
A study for the effect of intake of lactic acid bacteria on visceral fat, body fat, abdominal CT visual analysis
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of intake of food including lactic acid bacteria on visceral fat, body fat, abdominal CT visual analysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate abdominal visceral fat area and waist circumference when taking the test food continuously for 12 weeks
Key secondary outcomes
Evaluate body weight, BMI, total cholesterol, triacylglyceride, HDL-cholesterol, LDL-cholesterol, body fat percentage and muscle mass, abdominal CT (subcutaneous fat area, visceral fat area, psoas major muscle area), perimeter (neck, chest, arms, thighs, hips), subcutaneous fat thickness (chest, arms, thighs) when taking the test food continuously for 12 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food daily for 12 weeks
Interventions/Control_2
Intake of placebo daily 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 64 years of age
(2) Subjects whose BMI is 23 kg / m^2 or more and less than 30 kg / m^2.
(3) The average blood pressure, triglycerides, HDL-cholesterol, and blood glucose of the entire intake initiator are considered to be within the reference range of each item
Key exclusion criteria
(1)Subjects who regularly ingest food, health food or medicine rich in lactic acid bacteria or natto bacteria
(2)Subjects who are regularly ingest health food or medicine that affects body fat and lipid metabolism
(3)Subjects who are judged to be unsuitable for research from the results of screening test pre-examination
(4)Subjects who always use laxative when defecation
(5)Subjects who have taken antibiotics within 3 months before fecal sampling
(6)Subjects whose feces are unsuitable for research
(7)Subjects who are judged to be unsuitable for the study based on the results of clinical laboratory test or cardiopulmonary function
(8)Subjects who have been possibilities for emerging allergy related to the study
(9)Subjects who are on a diet at the time of screening testpre-examination
(10)Subjects who have diseases requiring regular administration, or who have severe diseases
(11)Subjects who are judged to be unsuitable for the study based on the results of clinical laboratory test or physical examination
(12)Subjects who are judged to be unsuitable for the study based on the results of lifestyle questionnaire
(13)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(14)Subjects who plan to get pregnant or nurse a baby during this study
(15)Subjects judged as unsuitable for the study by the investigator
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Kimiko |
| Middle name | |
| Last name | Uchiyama |
Organization
KAMEDA SEIKA Co., Ltd.
Division name
Rice Research Institute
Zip code
950-0198
Address
3-1-1 Kameda-kogyodanchi, Konan-ku, Niigata-shi, Niigata
TEL
025-382-8879
k_uchiyama@sk.kameda.co.jp
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Hashimoto |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
k.hashimoto@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
KAMEDA SEIKA Co., 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
t.saito@ttc-smo.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
| 2021 | Year | 11 | Month | 29 | 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
66
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
| 2020 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 22 | Day |
Last modified on
| 2021 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047035
