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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032404
Receipt No. R000036955
Scientific Title Verification test of body fat-reducing effect of lactic acid bacterium containing foods
Date of disclosure of the study information 2018/05/21
Last modified on 2018/10/29

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Basic information
Public title Verification test of body fat-reducing effect of lactic acid bacterium containing foods
Acronym Verification test of body fat-reducing effect of lactic acid bacterium containing foods
Scientific Title Verification test of body fat-reducing effect of lactic acid bacterium containing foods
Scientific Title:Acronym Verification test of body fat-reducing effect of lactic acid bacterium containing foods
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to verify the effects on body fat of test foods in men and women aged 30 years and older and under 65 years of BMI23 and under 30
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visceral fat area, body composition (body weight, body mass index, body fat percentage), and abdominal circumference
Key secondary outcomes Hematologic test, blood biochemical test, vital signs

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 Ingestion of test food containing a lactic acid bacterium for 12 consecutive weeks
Interventions/Control_2 Ingestion of placebo without a lactic acid bacterium for 12 consecutive 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
30 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1)Age: 30 and over, below 45
2)Sex: Males and females with Japanese nationality
3)Individuals with a BMI of 23 or more and less than 30 at screening (high-normal and 1st-degree obesity)
Key exclusion criteria 1)People who regularly drink or drink yogurt containing lactobacilli *Yogurt consumption will not be excluded if habit exists during the study
2)Persons who are unable to limit the use of drugs, health foods, foods for specified health use, functional labeling foods, health supplements, supplements, etc., which may affect body fat, as well as foods high in lactobacilli and oligosaccharides after obtaining informed consent
3)Subjects who were receiving medication at the time of study entry and were attending the clinic for body fat-related disease
4)Persons with or with a history of diseases such as diabetes, liver disease, kidney disease, or heart disease
5)Persons who have been diagnosed with familial hyperlipidemia
6)Persons currently undergoing exercise and diet therapy under the supervision of a physician
7)Persons who regularly engage in strenuous exercise
8)Persons with diseases requiring constant medication
9)Persons with a history of serious disease requiring medical treatment
10)Persons with a history of drug or food allergy
11)Patients who have metal in the CT scan measurement site due to surgery, etc.
12)Patients with cardiac pacemakers or implantable cardioverter defibrillators.
13)People with claustrophobia
14)Subjects who are judged inappropriate as subjects based on the responses to the background questionnaire
15)Subjects with significant deviations from reference ranges in pre-test physical, physical, and laboratory measurements
16)Pregnant, lactating women, or women who wish to become pregnant during the study
17)Persons with a current or past history of psychiatric disorders
18)Persons who work shift,such as night shift workers
19)Patients who are receiving or have a history of drug dependence or drug abuse.
20)Individuals who have participated in other human clinical studies or are currently participating in other human clinical studies within the past 3months
21)Other subjects who are considered inappropriate as subjects
22)Meetings are required
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
Email ochitani@huma-c.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
Homepage URL
Email ochitani@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization Pickles 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
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 05 Month 21 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
2018 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 27 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036955

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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