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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023927
Receipt No. R000027520
Scientific Title Effect of fragmented Lactobacillus amylovotus CP1563 on substrate oxidation and energy expenditure: a randomized cross-over trial
Date of disclosure of the study information 2016/09/04
Last modified on 2017/09/15

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Basic information
Public title Effect of fragmented Lactobacillus amylovotus CP1563 on substrate oxidation and energy expenditure: a randomized cross-over trial
Acronym Effect of fragmented Lactobacillus amylovotus CP1563 on energy metabolism
Scientific Title Effect of fragmented Lactobacillus amylovotus CP1563 on substrate oxidation and energy expenditure: a randomized cross-over trial
Scientific Title:Acronym Effect of fragmented Lactobacillus amylovotus CP1563 on energy metabolism
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore effect of fragmented lactobacillus amylovorus CP1563 on energy expenditure and substrate oxidation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Energy expenditure, Fat oxidation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of Lactobacillus amylovorus CP1563for 3 weeks, Wash out 1 week and ingestion of Placebo for 3 weeks.
Interventions/Control_2 Ingestion of placebo for 3 weeks, Wash out 1 week and ingestion of Lactobacillus amylovorus CP1563 for 3 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
50 years-old >
Gender Male
Key inclusion criteria 1) Subjects who can make self-judgment and are voluntarily giving written informed consent.
2) Males whose age 40 to 59 years old for Japanese.
Key exclusion criteria 1. Subjects who have diabetes in the second degree.

2. Subjects who have past surgical historyof gastroenterological surgery.

3. Subjects who use pharmaceuticals regularly.

4. Subjects who have an acute disease like a inflammation of the upper airway or acute gastroenteritis.

5. Subjects who excessive alcohol intake
and who have a smoking habit.

6. Subjects with allergies of lactobacillus, milk, soy and citrus.

7. Subjects who is irregular eating habits.

8. Subjects who are participating or will participate other clinical trials.

9. Others who have been determined ineligible by principal investigator or subinvestigator.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Tanaka
Organization Fukuoka univercity
Division name Faculty of Sports and Health Science
Zip code
Address 8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL +81-92-871-6631
Email htanaka@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoichi Hatamoto
Organization Fukuoka univercity
Division name Faculty of Sports and Health Science
Zip code
Address 8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL +81-92-871-6631
Homepage URL
Email y.hatamoto.7@gmail.com

Sponsor
Institute Fukuoka university
Institute
Department

Funding Source
Organization Asahi Holdings
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
2016 Year 09 Month 04 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
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 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
2016 Year 09 Month 04 Day
Last modified on
2017 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027520

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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