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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031023
Receipt No. R000035427
Scientific Title Effects of Lactic acid bacteria R037 on trigryceride elevation: randomized, double blind, placebo-controlled crossover study
Date of disclosure of the study information 2019/01/01
Last modified on 2018/01/26

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Basic information
Public title Effects of Lactic acid bacteria R037 on trigryceride elevation: randomized, double blind, placebo-controlled crossover study
Acronym Effects of Lactic acid bacteria R037 on
triglyceride elevation after high fat loading
Scientific Title Effects of Lactic acid bacteria R037 on trigryceride elevation: randomized, double blind, placebo-controlled crossover study
Scientific Title:Acronym Effects of Lactic acid bacteria R037 on
triglyceride elevation after high fat loading
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of lactic acid bacteria R037 on triglyceride level after high fat loading in subjects under normal high triglyceride level
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy:
1.Area under the triglyceride level-time curve
2.Changes of triglyceride level

Safety:
1. Doctor's questions
2. Subjective/Objective symptoms
3. Adverse events/Side effects
4. Blood pressures, Heart rate
5. Clinical laboratory tests at the end of the study
Key secondary outcomes Efficacy:
1.Area under the RLP-cholesterol level-time curve
2.Changes of RLP-cholesterol level
3.Total cholesterol
4.HDL-cholesterol
5.LDL-cholesterol

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Single ingestion of placebo tablets, and high fat loading
Interventions/Control_2 Single ingestion of active tablets containing 100 mg of lactic acid bacteria R037, and high fat loading
Interventions/Control_3 Single ingestion of active tablets containing 200 mg of lactic acid bacteria R037, and high fat loading
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.Healthy men and women between 30 and 65 years of age
2.Fasting triglyceride level is between 80 and 149 mg/dL
3.Subject who don't have heavy drink habit
4.Agreed the informed consent
Key exclusion criteria 01.Under medication
02.Who can't stop to take supplements which may affect lipid metabolism during the study
03.Who can't stop drinking two days before screening and each examination
04.Who have an allergy to test substance
05.Who have severe disease(s) including diabetes, kidney/liver disease, heart disease, or who have metabolic disease(s) including thyroid gland disease, adrenal disease or who is under medical treatment
06.Who have chronic disease and is under medication
07.Who have digestive disease or surgery history of digestive organ(s) affecting digestion and absorption of foods
08.Inadequate subject judged by screening
09.Judged anemia by screening and cannot tolerate frequent blood sampling
10.Who has diarrhea within 1 week from date of screening
11.Blood drawing over 200 mL within 1 month or over 400 mL within 3 months from date of informed consent
12.Familial hyperlipidemia
13.Drug addict and alcohol addict
14.Who is attending another study using different food supplement(s), pharmaceutical(s), and cosmetic(s). Or who will attend another study
15.Under pregnant, or nursing, willing to become pregnant during the study
16.Person who is inappropriate for the study judged by medical doctor
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Iwama
Organization Nihonbashi Cardiology Clinic
Division name Director
Zip code
Address Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL 03-5641-4133
Email yiwama@well-sleep.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshika Komori
Organization KSO Corporation
Division name Sales department
Zip code
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Kaneka 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
2019 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 29 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 01 Month 26 Day
Last modified on
2018 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035427

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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