UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification test of body fat-reducing effect of lactic acid bacterium containing foods
Title of the study (Brief title)	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	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
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	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 04 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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