UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Test of the energy metabolism-promoting effect of lactic acid bacteria beverage
Title of the study (Brief title)	Test of the energy metabolism-promoting effect of lactic acid bacteria beverage
Region	Japan

Condition
Condition	Obesity
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the energy metabolism-promoting efficacy and safety of lactic acid bacteria beverage
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	energy metabolism
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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	lactic acid bacteria beverage
Interventions/Control_2	lactic acid bacteria-free beverage
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Males and females aged 20 to less than 65 years old. 2) 25 kg/m2 <= BMI < 30 kg/m2.
Key exclusion criteria	1) Subjects who regularly take part in exercise and/or sports (except taking a walk) or do muscle training three times and more a week. 2) Subjects who are on a diet. 3) Subjects who have the habit of taking foods containing a high number of lactic acid bacteria (fermented milk drink, yoghurt, kimuchi, and so on) and/or lactic acid bacteria preparations three times and more a week. 4) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the body fat and/or fat metabolism, or who constantly use medicines and/or functional foods affecting the test results. 5) Subjects who take continuous medical treatment. 6) Subjects who have allergic reaction to food. 7) Subjects who drink alcohol a lot (20 g and more of alcohol a day on average) and/or smoke a lot (21 and more cigarettes a day on average) 8) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift 9) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	64

Research contact person
Name of lead principal investigator	Junichi Nakamura
Organization	Suntory Global Innovation Center Limited
Division name	Research Institute
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL	050-3182-0460
Email	Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person	Eiji Fukushima
Organization	Suntory Global Innovation Center Limited
Division name	Research Institute
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL	050-3182-0544
Homepage URL
Email	Eiji_Fukushima@suntory.co.jp

Sponsor
Institute	TTC Co.,Ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Suntory Beverage & Food Limited
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	2015 Year 07 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 23 Day
Anticipated trial start date	2015 Year 07 Month 27 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	2015 Year 07 Month 24 Day
Last modified on	2016 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021316